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  • Procedural readiness for first-in-human device trials: proctoring, simulation, dry runs and sign-off

    The contract is signed, the ethics committee has approved the protocol and the devices cleared customs last week. Then the first patient is on the table, the delivery system is in the physician’s hands for the first time under live fluoroscopy, and the scrub nurse is opening packaging she has only seen in a slide deck. That’s the morning when a first-in-human (FIH) device study is most fragile, and it’s where the early protocol deviations come from.

    I am Julio Martinez-Clark, CEO of bioaccess®. We run early feasibility and FIH device studies across Latin America for sponsors who plan to take the data to FDA. This page covers how I build procedural readiness before the first case: benchtop and simulation training, dry runs in the real room, device-placement training logs, proctor sign-off and a monitor check that ties it together. It also sets out what 21 CFR Part 812 actually asks for, and what it leaves to the sponsor. It sits next to our guide on foreign proctors and field engineers at FIH cases in Latin America, which covers the permits the visiting team needs to be in the room.

    This is operator guidance, not legal or medical advice. The device’s instructions, the investigational plan and the site’s own credentialing rules always come first.

    One-sentence answer

    Before the first subject is enrolled, every person who will touch the investigational device should have practiced the procedure on a bench or simulator against written pass criteria, rehearsed the case in the actual procedure room with the actual team, had each training session recorded in a log tied to the device version and protocol version, and been signed off by a qualified proctor, and the monitor should have checked those records against the protocol steps before the site is activated.

    What the evidence says about early cases

    There is no single number for how many deviations happen in the first cases of a device trial, and I’d be careful with anyone who quotes one without a source. Two published studies are worth knowing, as long as you read them for what they measured.

    • Deviations follow a learning curve. A retrospective analysis of the VALIANT trial (Taekman et al., Quality & Safety in Health Care, 2010) looked at 12,367 patients at 931 sites and found that protocol departures were more common for patients enrolled earlier at each site. In the authors’ words, compared with the 30th patient, the first had 47% more departures. Departures were also more common at sites that enrolled slowly. VALIANT was a drug trial in acute myocardial infarction, not a device study, but the pattern is the one every device sponsor sees: the first patients at a site carry the most risk of a departure from the plan.
    • Training to a benchmark beats training for time. A randomized study in JAMA Network Open (Mascheroni et al., 2023) compared two simulation curricula for 30 novice cardiac device implanters performing a virtual cardiac resynchronization therapy implant. The group that had to demonstrate a predefined proficiency level before advancing completed 27% more procedural steps and made 73% fewer errors and 84% fewer critical errors than the group that received the same simulation training without the proficiency requirement. That was measured on a simulator, not in patients and not as protocol deviations, so it shouldn’t be quoted as a clinical trial deviation rate. What it does show is that how you gate training matters as much as whether you do it.

    FDA’s draft guidance on protocol deviations (December 2024, non-binding and not yet final) draws the operational conclusion. It says sponsors should train investigators on the protocol to help them follow it, and should also train them to identify important protocol deviations. Its list of deviations FDA considers important includes implanting an incorrect device. It also notes that a high number of deviations at a site may suggest that more resources, such as staffing or training, are needed.

    What 21 CFR Part 812 requires, and what it doesn’t

    Part 812 doesn’t use the words “simulation” or “proctor,” and it doesn’t set a number of training cases. It does set the obligations that a training program has to satisfy, and an FDA reviewer or inspector will look for evidence of them.

    • Qualified investigators. Under § 812.43(a), the sponsor must select investigators qualified by training and experience to investigate the device. Under § 812.43(c), the signed investigator agreement includes the CV and, where applicable, a statement of relevant experience with dates, location, extent and type. Under § 812.43(d), monitors must also be qualified by training and experience.
    • Informed investigators. Under § 812.45, the sponsor must give every participating investigator the investigational plan and the report of prior investigations, which under § 812.27 covers the prior clinical, animal and laboratory testing of the device.
    • Written monitoring procedures. Under § 812.25(e), the investigational plan includes the sponsor’s written monitoring procedures. Under § 812.46(a), a sponsor who finds an investigator not complying with the agreement or the plan must promptly secure compliance or stop shipments and end that investigator’s participation.
    • Supervised device use. Under § 812.110(c), the investigator may let the device be used only with subjects under the investigator’s supervision, and may not supply it to anyone not authorized to receive it. That’s the basis for keeping the local investigator, not the visiting proctor, responsible for each case.
    • Deviation records and approvals. Under § 812.140(a)(4), the investigator keeps the protocol with documents showing the dates of and reasons for each deviation. Under § 812.150(a)(4), a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency must be reported to the sponsor and the reviewing IRB as soon as possible, and no later than 5 working days after the emergency. Outside an emergency, changes in or deviations from the plan need the sponsor’s prior approval, and, if they may affect the scientific soundness of the plan or the rights, safety or welfare of subjects, FDA and IRB approval as provided in § 812.35(a).
    • Data from outside the US. When data from a study run outside the US, such as an FIH study in Latin America, supports an IDE or a marketing submission, § 812.28(a)(1) asks for a statement that the study followed good clinical practice. Section 812.28(b) asks for a description of what the sponsor did to ensure it, including the investigators’ qualifications (b)(2), how the sponsor monitored the study and ensured it followed the protocol (b)(11), and how investigators were trained to comply with GCP and to conduct the investigation in accordance with the protocol (b)(12). That last item is the most direct regulatory hook for everything on this page: you will have to describe the training, so build it so it can be described.

    In other words, the regulation tells you to use qualified people, monitor them and document deviations. Benchtop work, dry runs, logs and proctor sign-off are how I make “qualified by training and experience” something I can show to a reviewer rather than something I assert.

    The readiness stack I use

    1. Benchtop and simulation training with pass criteria

    The physician’s general experience with similar procedures is the starting point, not the finish line. A novel delivery system, a new anchoring step or an unfamiliar sizing tool needs hands-on time before it goes near a patient.

    • Train on the bench model, anatomical phantom or simulator the engineering team used to verify the device, with the same device configuration and instructions for use that the site will receive.
    • Write the pass criteria before training starts: the steps that must be completed in order, the errors that fail a run, and the critical errors that fail it outright. Agree them with the lead investigator and the proctor.
    • Train the whole team, not just the implanter. The scrub nurse prepares and hands off the device, the technologist sets up imaging, the anesthesia team needs to know the expected procedure time and the points where the patient must not move.
    • Repeat until the criteria are met, and record each attempt. Hours spent at the bench prove attendance. A passed run against written criteria shows competence.

    2. A dry run in the real room

    The bench teaches the device. The dry run teaches the room. I schedule it at the site, in the procedure room where the first case will happen, with the people who’ll be on that case’s schedule.

    • Walk the case from patient arrival to recovery. Who checks eligibility on the day, who confirms consent, who opens which package and when, where the device and its backups sit.
    • Rehearse the handoffs on the sterile field and the imaging set-up for each step of the protocol.
    • Rehearse what happens when something goes wrong: the bailout plan in the protocol, who decides to stop, which backup devices are open, how the case is documented.
    • Check that the protocol-required measurements and images can actually be captured and saved the way the case report form expects.
    • Run it in the team’s working language. In most of our sites that’s Spanish or Portuguese, and the training materials and procedure checklist should be in that language too, approved under the site’s document control.

    Much of what a dry run catches isn’t clinical skill. It’s a missing extension cable, an imaging protocol that wasn’t loaded, a step in the case report form that nobody knew how to capture, or a device box stored where the sterile nurse can’t reach it.

    3. Device-placement training logs

    If it isn’t in the log, it didn’t happen. I set up the training log before training starts, so every session is recorded the same way. For each entry the log records:

    • The trainee’s name and study role, and the trainer’s name.
    • Date, location and training format (bench, simulator, dry run, proctored case).
    • Device model and version, and the revision of the instructions for use and of the protocol used for training.
    • The specific steps practiced, the pass criteria used and the result.
    • Signatures of trainee and trainer.

    The log goes into the investigator site file and the sponsor’s trial master file, alongside the delegation log. Two checks I run every time: nobody is delegated a device task on the delegation log without a matching training entry, and when the device or the instructions change, everyone affected is retrained and the log shows it. That record is also what lets the device receipt, use and disposition records under § 812.140(a)(2) match the people who actually handled the device. We cover the accountability side in our post on investigational device accountability in FIH studies.

    4. Proctor sign-off

    Proctoring is where the device’s most experienced operator watches, coaches and, when the plan allows it, steps in. Sign-off is the documented decision that a trainee can do the next case without that support, or with less of it.

    • Define in advance who can proctor, what qualifies them and how many proctored cases the plan calls for. Write it in the training plan, not in an email.
    • Use a sign-off form with the same criteria as the bench training: steps completed, errors, how the operator handled anything unexpected. The proctor signs, and the lead investigator acknowledges.
    • Keep the roles clear. The local investigator stays responsible for the subject under § 812.110(c). The proctor advises and, where the local authorization and the plan permit, assists.
    • Get the permits sorted before you book flights. In Colombia and Brazil, a foreign physician who takes part in a procedure needs an authorization requested by the host institution, and in Panama medicine is a profession reserved for nationals, with case-by-case routes. In Brazil the medical council asks for the request at least 30 days in advance. The details for Colombia, Brazil and Panama are in our foreign proctors guide.

    5. The monitor closes the loop

    Before site activation, the monitor checks the training log, the sign-offs and the delegation log against the protocol steps. After each of the early cases, I want a short debrief within days, not at the next routine visit: what deviated from the plan, why, and whether the cause was training, the device, the protocol or the room. My rule is that if the same deviation shows up twice, it gets a root-cause analysis and, if needed, retraining or a protocol clarification. FDA’s draft guidance, which is non-binding, recommends a root-cause analysis when similar deviations recur.

    A readiness gate before the first subject

    I don’t let a site enroll until these are true and filed:

    1. Every person on the delegation log for a device task has a passed bench or simulator run against written criteria.
    2. A full dry run has been done in the actual procedure room with the first-case team, and the issues it found are closed.
    3. The training log is complete, signed, and tied to the current device version, instructions for use and protocol.
    4. Proctor qualifications, the number of proctored cases and the sign-off criteria are written into the training plan.
    5. Any visiting proctor or field engineer has the local authorization the country requires, or a documented reason none is needed.
    6. The monitor has reviewed the training records against the protocol and signed off on activation.
    7. The deviation reporting route is clear to the site team: what goes to the sponsor, what goes to the ethics committee and in what time frame.

    This gate sits after the regulatory and ethics gate we describe in our cross-functional FIH readiness gate and the investigator selection steps in how we qualify FIH sites and investigators.

    Common mistakes

    • Treating a slide deck at the site initiation visit as device training.
    • Training only the implanting physician and not the nurses, technologists and anesthesia team.
    • Measuring training in hours instead of against pass criteria.
    • Skipping the dry run because the team “does this procedure every week” with a different device.
    • Training on one device version and shipping another, without retraining or a log entry.
    • A proctor who arrives without the local authorization, so the first case moves or the proctor watches from outside the room.
    • Waiting for the next scheduled monitoring visit to review the first case’s deviations.

    How bioaccess® runs this

    On our FIH and early feasibility studies, we build the training plan with the sponsor’s clinical and engineering team, translate and control the site materials, schedule the bench sessions and the dry run around the site’s procedure calendar, file the logs and sign-offs, and handle the visiting team’s local authorizations. Our monitors review the training records before activation and debrief the site after each of the early cases. If you are planning a first-in-human device study in Latin America, you can contact us.

    FAQ

    Does 21 CFR Part 812 require proctoring or simulation training?

    Not by name. Part 812 requires investigators and monitors qualified by training and experience (§ 812.43), written monitoring procedures (§ 812.25(e)) and records of deviations (§ 812.140(a)(4)). Proctoring, simulation and training logs are the usual way sponsors meet and document those requirements for a novel device.

    How many proctored cases should a site do?

    There’s no regulatory number. It depends on the device, the procedure and how close it is to what the team already does. Set it in the training plan before the first case, and base sign-off on criteria rather than a count alone.

    Can the visiting proctor be the operator?

    Only if the plan allows it and the country authorizes it. Under § 812.110(c) the device can only be used with subjects under the investigator’s supervision, and in Colombia and Brazil a foreign physician needs a local authorization, requested by the host institution, to take part in a procedure. See our foreign proctors guide.

    What happens if there’s a deviation in the first case?

    Record it with the date and reason, as § 812.140(a)(4) requires. If it was an emergency deviation to protect the subject, notify the sponsor and the IRB as soon as possible and within 5 working days under § 812.150(a)(4). Any other deviation should have had the sponsor’s prior approval, so treat it as a compliance finding and report it the way the protocol and the ethics committee require. Then debrief the team before the next case and decide whether the cause calls for retraining, a protocol clarification or a change to the room set-up.

    Sources: 21 CFR Part 812, §§ 812.25(e), 812.27, 812.28(a)(1) and (b)(2), (b)(11) and (b)(12), 812.35(a), 812.43(a), (c) and (d), 812.45, 812.46(a), 812.110(c), 812.140(a)(2) and (a)(4) and 812.150(a)(4) (eCFR, current as of October 2026); FDA, Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices, draft guidance for industry (December 2024); Taekman JM et al., “Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve,” Quality & Safety in Health Care, 2010 (doi:10.1136/qshc.2008.028605); Mascheroni J et al., “Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters,” JAMA Network Open, 2023;6(8):e2322750 (doi:10.1001/jamanetworkopen.2023.22750).

  • Breaking Into GLP-1 Trials Without Prior GLP-1 Experience: The Transferable Evidence Sponsors Actually Screen For

    Every sponsor running a glucagon-like peptide-1 (GLP-1) program has the same problem: more sites want in than the protocol can support, and the first screening call is usually short. In our experience, sites expanding from adjacent specialties — orthopedics, rheumatology, general cardiology — often lose that call early. Not because they lack ability, but because they answer feasibility questions the way sites answered them a decade ago: with enthusiasm, an equipment list, and a claim about patient access that nobody can verify.

    Prior GLP-1 experience helps, but it is not the only evidence sponsors accept. What wins the call is transferable evidence — documented proof from the work you already do that maps directly onto what a GLP-1 trial demands. This article lays out what that evidence is, what carries no weight, and how to assemble it in about two weeks.

    Why Sponsors Screen GLP-1 Feasibility Differently

    GLP-1 trials are not ordinary outpatient studies, and experienced sponsors know where they fail:

    • Demand cuts both ways. Public use of these drugs is already widespread: in a KFF poll fielded October 27 to November 2, 2025, 18% of US adults said they had ever taken a GLP-1 drug and 12% said they were taking one at the time. Recruitment interest is rarely the problem. The work is screening out volunteers who do not meet eligibility criteria (check each protocol’s rules on prior or current GLP-1 use) and managing the disappointment of those randomized to placebo.
    • Retention is the real risk. These protocols run long. FDA’s January 2025 draft guidance on weight-reduction drugs describes long-term effect as at least one year on the maintenance dose. The STEP 1 trial of semaglutide 2.4 mg ran 68 weeks, with dose escalation every four weeks up to week 16. Gastrointestinal side effects cluster early: in a pooled analysis of STEP 1–3, they occurred most often during or shortly after dose escalation, and nausea, diarrhea and vomiting peaked around week 20. A site that enrolls fast and loses patients by month three is worse than a site that enrolls steadily and keeps them.
    • Injection training is a protocol task, not a detail. In injectable programs, participants usually self-inject at home between visits. The Wegovy prescribing information, for example, tells prescribers to train patients on injection technique before the first dose and to delay escalation when a dose is not tolerated. Sites must teach technique, document training, and handle missed-dose and storage questions for the full study duration. Oral programs change the details, not the adherence burden.
    • Metabolic monitoring must be exact. Weight, body mass index (BMI), hemoglobin A1c (HbA1c), and laboratory values are primary data, not background information. In FDA’s weight-reduction draft guidance, the primary efficacy endpoint is the mean percentage change in body weight; in FDA’s 2023 draft guidance on diabetes efficacy endpoints, HbA1c remains an acceptable primary endpoint for glycemic control. Sloppy measurement discipline shows up directly in the endpoint data.

    Every feasibility question a sponsor asks is really one of these four risks in disguise. Answer the risk, not the question.

    The Transferable Evidence That Actually Carries Weight

    1. An adjacent cardio-metabolic enrollment record. You do not need a prior GLP-1 study. You need documented enrollment in conditions that share the same patient: type 2 diabetes, hypertension, dyslipidemia, cardiovascular risk-reduction studies. Name the therapeutic area, the enrollment target, what you actually randomized, and your screen-failure rate. Specifics from adjacent work beat adjectives about the new indication every time.

    2. A verifiable count of your own eligible patients. Run a query against your electronic health record (EHR) system using the protocol’s headline criteria — age range, BMI threshold, HbA1c range, key exclusions — and report only the aggregate, de-identified count. Under the HIPAA Privacy Rule, reviewing records to prepare for research is a defined pathway with conditions, including that no protected health information leaves the covered entity (45 CFR 164.512(i)(1)(ii); see also HHS research guidance), so involve your privacy officer. For example, a sentence such as “214 active patients in our practice met the published inclusion criteria as of this month” (an illustrative number) is something a sponsor can act on. It proves the patients exist, that your team can operate its own records, and that your recruitment estimate has a denominator.

    3. Principal investigator oversight in metabolic care. The principal investigator (PI) does not need a GLP-1 publication. The PI needs a credible story of managing metabolic patients over time: titration decisions, comorbidity management, and longitudinal follow-up. In our experience, sponsors are screening for clinical judgment across a long trial, not for a bibliography in one molecule class.

    4. Documented startup speed. Give dates, not promises: your average time from contract execution to site activation, and from activation to first patient in (FPI), across your last several studies. For example, a site that can show a consistent 45-day path to activation (an illustrative figure), with the paperwork to prove it, is a lower-risk choice than a famous site with no timeline data.

    5. A retention system, described concretely. Explain your reminder cadence, how you handle visit windows when a participant travels, who on your staff owns lifestyle and adherence support between visits, and your historical retention rate on your longest completed study. Retention is where GLP-1 trials are won or lost, and in our experience many sites improvise it.

    What Does Not Work

    • “Access to thousands of patients.” Without a query, a date, and criteria, this is noise — and reviewers hear it constantly.
    • Equipment lists. Every credible site has the equipment. It is a threshold requirement, not evidence of capability.
    • Generic enthusiasm for the indication. Interest in weight management is assumed. It differentiates no one.
    • Borrowed credentials. Listing affiliated physicians who will not actually see study patients surfaces quickly — usually at the site selection visit — and can end the conversation for good.

    A Two-Week Checklist for Sites Without GLP-1 Experience

    • ☐ Pull your enrollment history for cardio-metabolic studies: targets, actual randomized numbers, screen-failure rates.
    • ☐ Run one de-identified EHR query against a current GLP-1 protocol’s published criteria (with your privacy officer’s sign-off); date and save the aggregate output only.
    • ☐ Write a one-paragraph PI summary focused on longitudinal metabolic care, not publications.
    • ☐ Compile activation and FPI dates from your last three to five studies into a single timeline.
    • ☐ Document your retention workflow: reminder cadence, visit-window handling, injection-training documentation, and the staff role responsible for between-visit support.
    • ☐ Record your retention rate on your longest completed trial.
    • ☐ Assemble these into a two-page capability brief you can send within one business day of any feasibility request.

    Our Perspective

    At bioaccess®, the first-in-human clinical research organization (CRO) for the Americas — the US, Canada and Latin America — we qualify sites and investigators for sponsors’ early-stage programs. Our sister company, Amavita Research Services, is a cardiovascular clinical research site in Miami, so we also answer these questionnaires from the site side. Working both sides taught us the lesson this article is built on: sponsors do not fund potential. They fund evidence. Sites that learn to present the evidence they already have — precisely, verifiably, and matched to the protocol’s real risks — get shortlisted in indications they have never run before. For what feasibility numbers look like on the recruitment side, see our article on patient recruitment feasibility for first-in-human trials.

    FAQ

    Can a site with no GLP-1 trial experience get selected for a GLP-1 study?

    In our experience, yes. Sponsors do select sites without indication-specific experience when the site presents transferable evidence: documented enrollment in adjacent cardio-metabolic conditions, a verifiable count of eligible patients from its own records, and a concrete retention system.

    What patient number should a site quote in a GLP-1 feasibility response?

    An aggregate, de-identified count from the site’s own electronic health record (EHR) query, run against the protocol’s actual inclusion and exclusion criteria and dated. Keep the query within HIPAA’s preparatory-to-research conditions. An unverifiable estimate of “thousands of patients” carries no weight with reviewers.

    What matters more in GLP-1 feasibility: enrollment speed or retention?

    Retention, in our view. GLP-1 protocols are long — STEP 1 ran 68 weeks — and gastrointestinal side effects cluster during dose escalation. Sponsors screen for reminder systems, visit-window discipline, and between-visit support because a patient lost at month three costs more than a patient enrolled a month later.

    How long does it take to build a credible GLP-1 feasibility package?

    About two weeks for a site with organized records: one EHR query, an enrollment history summary, activation and first-patient-in timelines from recent studies, and a written retention workflow.

    Sources: KFF Health Tracking Poll (fielded October 27 to November 2, 2025); FDA, Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction, draft guidance (January 2025); Wilding JPH et al., Once-Weekly Semaglutide in Adults with Overweight or Obesity, N Engl J Med 2021;384:989-1002 (STEP 1); Wharton S et al., Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, Diabetes Obes Metab 2022 (pooled STEP 1–3); WEGOVY prescribing information (FDA, 2025); FDA, Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products, draft guidance (May 2023); 45 CFR 164.512(i)(1)(ii); HHS, Research (HIPAA Privacy Rule guidance).

  • The DDR in Brazil: how a registration holder authorizes a third party to import a medical device

    The question usually comes a few weeks after the ANVISA registration is published. The manufacturer has a distributor or a hospital ready to buy, the first shipment is booked, and someone asks the holder for “the authorization letter.” In Brazil that request has a precise regulatory meaning. If the company clearing the device through customs is not the registration holder, ANVISA expects a specific document on the import file: the Declaração do Detentor da Regularização do Produto Autorizando a Importação por Terceiro, which everyone calls the DDR. If it’s missing, the import is rejected outright.

    I am Julio Martinez-Clark, CEO of bioaccess®. We act as the in-country registration holder for medical device manufacturers in Latin America, and this question keeps coming up. This page covers what the DDR is, what the rules require, how it differs from a commercial authorization letter, what changes when the device is still investigational, and the checklist I use so the first commercial shipment doesn’t sit at the port.

    One-sentence answer

    When anyone other than the ANVISA registration holder imports a registered device into Brazil, each import file must include a DDR on ANVISA’s own template, linked to one importer and to the products on that import license, valid for no more than 90 days and signed by the holder’s legal representative and its technical responsible. The holder stays legally responsible for the product in Brazil.

    What the rules actually require

    The import regulation: ANVISA RDC 81/2008

    Brazil’s technical regulation on imported goods under health surveillance is RDC 81 of 5 November 2008. ANVISA’s legislation database lists it as in force with amendments. The import-file rules quoted here were rewritten by RDC 208/2018, and the regulation was amended again in 2025. Chapter VII covers outsourced (“terceirizada”) imports:

    • Who counts as a third-party importer. Item 1 covers imports between companies that hold ANVISA operating authorization (AFE) to import, or to import and manufacture; imports by predetermined intermediation (the “encomenda” and “conta e ordem” models); and imports by public health bodies and multilateral international organizations.
    • The holder keeps the obligations. Item 5 puts the following on the holder of the product’s ANVISA regularization: compliance with the import rules at every step from shipment abroad to health clearance in Brazil, good practices in transport, handling and storage, and responsibility for the information on the import, even when a third party supplied it. Item 5.2 adds that the third-party importer still has to follow the regulation itself.
    • The fee follows the holder. Item 6 says the health surveillance inspection fee (TFVS) is set by the size of the legal entity that holds the regularization, not by the importer’s size.
    • The DDR, on every import. Item 7 says a third-party import goes ahead with the health authority’s consent, and that each import must include the clearance petition and a declaration from the holder authorizing the import. Under item 7(b), that declaration must (i) be tied to one single, exclusive legal entity, with any onward transfer of the authorization prohibited; (ii) be legally valid for no more than 90 days from signature; (iii) be signed by the holder’s legal representative and its technical responsible; and (iv) state the commitment to follow health legislation and acknowledge the penalties under Law 6.437/1977. For predetermined intermediation, item 7(c) also requires the authorization form in Chapter VIII.

    For medical devices specifically, Procedure 4 in Chapter XXXIX makes device imports subject to an import license (LI) in SISCOMEX and health inspection before customs clearance (item 33). Item 36 lists the documents for the import file: the clearance petition, the commercial invoice, the bill of lading, proof of sterility for sterile products, and the declaration from the holder authorizing import by a third party.

    Who the “holder” is: RDC 751/2022

    ANVISA’s device registration rule, RDC 751/2022, defines the holder (Art. 4, VIII) as the public or private legal entity, manufacturer or importer, that is responsible for the device in Brazil and holds the marketing concession issued by ANVISA. The DDR is how that entity lets another company bring the product in without handing over that responsibility.

    What ANVISA says about the template

    • Two official models. ANVISA publishes the DDR for third-party importers on its forms page and a separate DDR for imports by health facilities. According to ANVISA’s notice on the current models, the first applies to companies that only do outsourced importing. The second applies to hospitals and health facilities that import directly for their own therapeutic or diagnostic use, and those products may not be passed on to another facility or sold.
    • Tied to the import license. The same notice says the models now cite the import license that covers the products. A DDR that lists products outside the license under review is not allowed.
    • Responsibility doesn’t move. ANVISA describes the DDR as the document that shows the holder knows all obligations for the product in Brazil are its own, and that they can’t be transferred to another company.

    ANVISA’s manual for reviewing device import files (PAFPS, version 2, July 2018), section 8.1.4, adds the practical rules reviewers apply:

    • The DDR is mandatory whenever the importer is not the holder.
    • Only the model on ANVISA’s website may be used. No changes to its form or wording are allowed.
    • File one DDR per import license, listing only the products on that license. A DDR with products not on the license goes into an “exigência” (a request for correction).
    • The legal and technical responsible may sign by hand or digitally. A digitally signed document that was printed, scanned and attached is not accepted, because the signature can’t be verified. An e-CNPJ certificate validates only the legal representative’s signature, so the technical responsible has to sign another accepted way.
    • A missing DDR leads to summary rejection of the import.

    Sections 8.1.5 and 8.1.6 of the manual cover two related documents. The Chapter VIII responsibility form applies only to “encomenda” and “conta e ordem” imports. It is signed by the holder’s legal representative and technical responsible and by the importer’s legal representative. A complementary fee is due when the importer is a smaller company than the holder, which follows from item 6 above.

    DDR versus a “commercial authorization letter”

    This is where most first shipments go wrong. A commercial authorization letter (distributor appointment, territory, exclusivity) is a private document between the manufacturer, the holder and the distributor. It may be very useful for tenders or customers, but it isn’t the DDR, and ANVISA won’t accept it in place of one. The DDR has no commercial terms. It is a fixed regulatory template that ties one importer to the products on one import license for a period of up to 90 days. When someone asks for “the letter,” my first question is which of the two they need. For a first import, it is almost always the DDR, sometimes both.

    Why it matters if you use an independent holder

    Many manufacturers keep their registration with a neutral holder so they can add or change distributors without re-registering. I explained why on our page about keeping the license separate from the channel. The DDR is what makes that model work day to day. Every distributor that imports needs its own DDR, and the authorization can’t be passed on. Each DDR lasts at most 90 days and covers only the products on one import license, so a distributor importing every month needs a steady flow of DDRs from the holder. The holder still carries the obligations under item 5. So a good holder reviews each request: whether the importer has the right authorization, whether the products and presentations match the registration, and whether there is an open field action or complaint that should hold the shipment. That review protects the manufacturer. It is not red tape.

    If the plan is to move the registration itself to a new company, that is a different process, covered in how to transfer a device registration to a new holder. The DDR leaves the registration where it is and authorizes imports under it.

    What changes in a first-in-human or early feasibility study

    An investigational device has no registration yet, so there is no holder and no DDR. In Brazil, devices for clinical investigation are imported under the Clinical Investigation Dossier (DICD) set out in RDC 837/2023:

    • Art. 70: the import is subject to health inspection through a clearance petition in SISCOMEX, and the importer must put the number of the Official Gazette (DOU) resolution approving the DICD in the product description.
    • Art. 71: the file needs the bill of lading and the commercial invoice. If someone other than the DICD holder imports, a document delegating import responsibilities, signed by both parties, is required. That is the trial-side counterpart of the DDR.
    • Arts. 72 to 75: the outer packaging must show the DICD resolution number, storage conditions and a lot or serial number. Products or quantities not covered by the DICD may not enter. The products may not be sold, and the purpose of the import may not change.

    I plan both paths together. The importer of record you choose for the study (see importer of record for clinical trial devices) and the unit-level trail you keep (see investigational device accountability) are often what sets up the commercial structure later, once the device is registered.

    How I set it up

    1. Name the import model first. Is it a third-party importer buying for its own resale, an “encomenda” or “conta e ordem” import (which adds the Chapter VIII form), or a hospital importing for its own use (the health-facility DDR)? Each uses a different document set.
    2. Check the importer before signing. Chapter VII, item 1.1 covers imports between companies with ANVISA operating authorization to import. Get the importer’s CNPJ and AFE details at the start, because the Chapter VIII form asks for them as well.
    3. Build the DDR from the import license. The product list on the DDR should match the license line for line. Nothing extra and nothing missing.
    4. Use the current ANVISA template as published. Download it fresh. Don’t reformat it, translate it or add a letterhead that changes the text.
    5. Sort out signatures early. You need both the legal representative and the technical responsible, in a format ANVISA can verify. Don’t print and scan a digitally signed file, and don’t rely on e-CNPJ alone for the technical responsible.
    6. Track the 90-day clock. I keep a register of every DDR issued: importer, import license, products, signature date and expiry. That way nothing expires in transit, and the holder can show who it authorized.
    7. Check the fee. If the importer is smaller than the holder, have the complementary fee paid and attached before the file is finally filed.

    Common mistakes

    • Sending a commercial authorization letter where ANVISA expects a DDR.
    • Issuing one open-ended DDR for “all products, all shipments,” or one that names two importers.
    • Letting the distributor’s customs broker reuse a DDR issued to another company.
    • Signatures that ANVISA can’t verify, or a missing technical responsible.
    • Listing presentations or models that are on the registration but not on the import license under review.
    • Assuming the DDR moves product responsibility to the importer. ANVISA says it can’t. The holder stays responsible.

    How bioaccess® runs this

    When bioaccess® is the Brazil registration holder, we handle DDR requests ourselves. We confirm the import model, check the importer’s authorization, prepare the ANVISA template from the import license, collect the legal and technical signatures and keep the register. The manufacturer’s distributors deal with us, so the holder’s controls and contact details stay in one place. The same approach applies across the countries on our market access page, and the Brazil specifics are on our ANVISA registration holder page.

    FAQ

    Is the DDR needed if the holder imports the device itself?

    No. ANVISA’s import manual says the DDR is required whenever the importer is not the holder. If the holder is also the importer on the license, no DDR is needed.

    How long is a DDR valid?

    No more than 90 days from signature, under RDC 81/2008, Chapter VII, item 7(b)(ii). In practice it is also tied to the specific import license it cites.

    Can one DDR cover two distributors?

    No. Item 7(b)(i) ties it to one single, exclusive legal entity and prohibits passing the authorization on.

    We are only running a clinical study. Do we need a DDR?

    No. Investigational devices are imported under the DICD rules in RDC 837/2023. If the importer is not the DICD holder, you need the signed delegation of import responsibilities instead.

    Sources: ANVISA RDC 81/2008 (as amended, including by RDC 208/2018), Chapter VII, items 1, 5, 6 and 7, Chapter VIII, and Chapter XXXIX, Procedure 4, items 33 and 36; ANVISA RDC 751/2022, Art. 4, VIII; ANVISA RDC 837/2023, Arts. 70 to 75; ANVISA, “Novos modelos de DDR já estão disponíveis” (published 4 July 2022); ANVISA DDR forms pages (third-party importer and health facility); ANVISA, Manual de Análise de Processo de Importação de Produtos para Saúde, PAFPS, version 2 (July 2018), sections 8.1.4 to 8.1.7.

  • How to Run a First-in-Human Medical Device Clinical Trial in Costa Rica: The Regulatory Pathway

    General information, not legal advice. Requirements change and each ethics committee applies its own procedures. Confirm with the scientific ethics committee (CEC), CONIS and Costa Rican counsel before you commit a timeline. Last verified 28 October 2026.

    This is our one-page regulatory pathway for a first-in-human (FIH) medical device clinical trial in Costa Rica. It is written for sponsors who already have a protocol and want to know who approves what, in what order, what it costs, and where the time goes. Every rule below is linked to the public source we read it from. Where the law is silent, or where we only have experience and no published data, we say so.

    Key takeaways

    • One law, one regulation. Clinical research in humans is governed by Ley 9234 (Ley Reguladora de Investigación Biomédica, 2014) and its regulation, Decreto Ejecutivo 39061-S (2015, as amended by 39533-S).
    • The ethics committee is the gate. A CONIS-accredited CEC must approve the protocol in writing before anything starts. Each committee sets its own submission format, fees and meeting calendar, so ask the CEC that will review your study.
    • CONIS registration plus a 3% levy. The approved study is registered with CONIS, the national health research council under the Ministry of Health. At registration the principal investigator pays CONIS 3% of the total study budget (Ley 9234, art. 60).
    • Insurance must be enforceable in Costa Rica, and the Spanish consent form has to describe the policy.
    • Device import comes last. Investigational units may be imported only after CEC approval and CONIS registration (Decreto 39061-S, art. 55).
    • Public (CCSS) hospitals add a second layer: their own regulation, a central CCSS committee, a contract signed by the CCSS and CCSS tariff-based cost recovery. Plan for materially longer than a private site.

    The legal framework

    • Ley 9234 regulates biomedical research with humans in both public and private settings and creates CONIS (official SCIJ text).
    • Decreto 39061-S sets out the submission package, committee deadlines, the levy and the rules for importing investigational products (consolidated copy; official SCIJ record).
    • Reglamento de Investigación Biomédica de la CCSS (La Gaceta, Alcance 50, 10 March 2021) applies only at CCSS public facilities (PDF from CENDEISSS).
    • CONIS lists all three on its legislation page.

    An investigational device does not need Costa Rican sanitary registration to be used in an approved study. The regulation authorizes the import and use of registered and unregistered products for research purposes, limited to studies that are properly approved and registered (Decreto 39061-S, art. 53). Commercial registration later is a separate file. See how to register a medical device with MINSA.

    Step 1: Choose the site, and with it the committee

    In Costa Rica the site and the ethics committee choice go together:

    • Private hospital or research center. The study normally goes to that institution’s own CONIS-accredited CEC, or to another accredited CEC if it has none. Each committee publishes, or will send you, its own forms, fees and session dates. Ask that CEC directly what it requires; there is no single national form. See the table of private and university CECs below.
    • CCSS public hospital. Proposals go to one of the CCSS’s central CECs (CEC-CENTRAL), not to a committee chosen by the sponsor (CCSS regulation, art. 14). See the CCSS section below.
    • Is a device FIH “Phase I”? Ley 9234 makes the Ministry of Health’s own committee (CEC-MS) the only committee in the country that can approve Phase I and bioequivalence studies (art. 46, as summarized in the Ministry’s CEC-MS notice). The law defines the phases in drug and vaccine terms. Whether a given device FIH is routed to CEC-MS or can be reviewed by a site CEC should be confirmed in writing with CONIS or the committee before you plan the calendar.

    Every investigator must be accredited by CONIS and hold a Good Clinical Practice course certificate less than three years old (Decreto 39061-S, art. 44(z)–(aa)).

    Step 2: Build the Spanish submission package

    Decreto 39061-S art. 44 lists the package for any experimental, clinical or interventional study. For a device FIH the items that usually drive the schedule are:

    • Protocol and investigator’s brochure in the original language plus an official Spanish translation, dated and versioned (art. 44(b)–(c)).
    • Informed consent in Spanish, in plain language (art. 44(d)). Ley 9234 art. 11(f) requires it to address the insurance policy.
    • IDE or equivalent, or a copy of an approval letter from FDA, EMA or another recognized agency, unless CONIS grants a qualified exception or the research is of Costa Rican authorship (art. 44(h)).
    • Device classification by FDA, EMA or another recognized agency (art. 44(i)).
    • Evidence the device was made under good manufacturing practice, plus a sterility certificate for sterile devices (art. 44(r)).
    • The investigator–sponsor contract and the study budget (art. 44(l)–(m)). The budget matters twice: the CEC reviews it, and the 3% CONIS levy is calculated on it.
    • Insurance policies and sponsor commitments on injury treatment and compensation (art. 44(jj)–(ll)).
    • A commitment to provide the study product free after the trial where it proved beneficial (art. 44(mm); Ley 9234 arts. 28 and 53). See our note on post-trial access for devices.
    • Site description, team CVs, CONIS accreditations and conflict-of-interest declarations (art. 44(p), (z)–(cc)).
    • A sworn statement naming any CRO (OIC) or site management organization (OAC) and its CONIS accreditation (art. 44(tt)).

    Step 3: Insurance enforceable in Costa Rica

    A civil liability policy is mandatory (Ley 9234, art. 31). It must be valid and enforceable in Costa Rica, through an insurer with branches or service centers in the country (Decreto 39061-S, art. 14(f)). It covers participants from consent signature until three years after their participation ends, and the sponsor must also cover the investigator and team. Each participant receives proof of the policy with the consent form. There is no monetary minimum in the law. Full detail: Costa Rica clinical trial insurance under Ley 9234, and the country-by-country LATAM clinical trial insurance guide.

    Step 4: CEC review

    Committees must rule on approval, rejection or renewal within one calendar month from the business day after the submission (Decreto 39061-S, art. 42). In practice that clock only helps if the package is complete. Query cycles, translation fixes and committee session calendars add time, and none of that is published. Resolutions can be appealed to the committee and then to CONIS.

    Step 5: CONIS registration and the 3% levy

    Once the CEC approves, the study is registered with CONIS. To register, the principal investigator pays CONIS 3% of the total research budget, and a copy of the signed contract, reviewed by the CEC, goes to CONIS (Ley 9234, art. 60, as quoted by the CCSS’s CENDEISSS FAQ). CONIS verifies the payment, which goes into a CONIS collection account (Decreto 39061-S, art. 49). Studies declared of public interest or a health priority can apply for an exemption (Ley 9234, art. 61; Decreto art. 50). A sponsored device FIH normally will not qualify. Budget the levy from day one and keep the CEC budget and the CONIS budget identical.

    Step 6: Institutional authorization

    CEC approval does not by itself open the site. Under Ley 9234 the health center where the study runs, public or private, must also authorize it. At a private site this is usually a letter from the institution’s legal representative or medical director. At a CCSS hospital it is a multi-office process, described next.

    Step 7: Import the investigational devices

    Investigational devices may be imported only after the study is approved by the CEC and registered with CONIS. Before the first shipment, the investigator or importer files with CONIS a list of the units and supplies needed for the whole study, approved beforehand by the CEC. CONIS uses it to issue the sanitary authorization for each customs entry, and any increase needs a new approval (Decreto 39061-S, art. 55(a)–(b)). Every product must be traceable through the supply chain to the site (art. 54).

    Public CCSS hospitals versus private sites

    The Caja Costarricense de Seguro Social (CCSS) runs the public hospitals. Sponsored studies are allowed there, but under an extra regulation with its own committees, offices and contract:

    • Pre-review sign-offs. The service head and the hospital’s medical director must sign a “no objection” on the application before the CEC sees it (CCSS regulation, art. 73(b); CENDEISSS requirements). The regulation sets no deadline for this step.
    • Central CCSS committee reviews the protocol: 30 calendar days for full-committee review from a complete submission, 15 for expedited review (arts. 14, 17, 18). A CCSS review fee applies; for the second half of 2026 it is ₡1,442,664 for a first submission (CENDEISSS tariffs).
    • A CCSS employee on the team. Every study run in the CCSS must include at least one CCSS staff member, accredited by CONIS, as principal investigator or sub-investigator (art. 13). The CENDEISSS checklist adds that if the principal investigator is not a CCSS employee, a CCSS employee must be named sub-investigator and shares responsibility for the study with the principal investigator (CENDEISSS requirements, item 1). An investigator who is not on CCSS staff cannot run a study at a CCSS hospital alone.
    • Contract before approval. For sponsored studies, the contract between the investigator, the CCSS, the sponsor and any CRO or site-management company must be signed before the CEC authorizes the protocol (art. 12).
    • Conditions for industry studies: the study must be of institutional interest, must not affect patient care, must use idle capacity, and must benefit the CCSS and participants (art. 27).
    • Cost recovery. The sponsor pays the CCSS direct, indirect and administrative costs under the CCSS tariff model. Costs not in the tariff are set by the CCSS cost-accounting area, which has up to 30 calendar days (arts. 28, 77).
    • A three-party contract between the CCSS (signed by the CENDEISSS director), the investigator and the sponsor or CRO. The regulation gives 10 business days to draft it, 5 for legal review and 5 to sign (arts. 31, 69(i), 70(f), 75).
    • Sponsor paperwork. The sponsor must be current with CCSS obligations, file sworn statements on the origin of funds and, if foreign, provide apostilled corporate documents and powers of attorney with official Spanish translations (arts. 29–30).
    • Start authorization by the hospital authority within 5 business days of the CEC’s request (art. 73(c)).

    CCSS central CEC: the rules, the package and the fees

    The CCSS rules come from its Reglamento de Investigación Biomédica (La Gaceta, Alcance 50, 10 March 2021). The articles that matter most for a sponsored device study:

    • Art. 12, approval. Research is allowed in CCSS units only if it does not disrupt the unit and respects patients’ rights. It needs approval by a CONIS-accredited CCSS committee and authorization by the competent CCSS authority, plus CENDEISSS authorization (through its research area, AISSS) and CONIS registration. If a hospital director objects, the matter goes to the CCSS General Management for a final decision. For sponsored studies, the contract between the investigator, the CCSS, the sponsor and any CRO or site-management company must be signed before the committee authorizes the protocol.
    • Art. 13, CCSS staff. At least one CCSS employee, accredited by CONIS, must be principal investigator or sub-investigator. The only exception is research for an academic degree, which needs a CCSS tutor instead.
    • Art. 14, where to submit. Proposals go to one of the CCSS central committees (CEC-CENTRAL). Its technical secretariat checks that the package is complete and on the official forms.
    • Art. 27, conditions for sponsored studies. The study must be of institutional interest; must not affect patient care (study tasks during normal care hours can be done by trained third parties with the unit’s authorization); must use idle capacity of facilities and equipment; must benefit the CCSS and participants; must recognize the CCSS in publications; and must have a signed contract.
    • Art. 28, payments. Sponsored studies pay the CCSS direct, indirect and administrative costs under the CCSS health-insurance tariff model, based on the total study budget. Items not in the tariff are priced by the CCSS cost-accounting area within 30 calendar days. The money goes to the CENDEISSS research and innovation fund.
    • Art. 73, the hospital authority. The head of the hospital gives the administrative no-objection before committee review, coordinates the start within 5 business days of the committee’s request, informs the service head, and grants electronic-record access to authorized investigators.

    The submission package. The CENDEISSS checklist for interventional studies has 22 protocol items. In summary:

    • An investigator’s request letter (naming a CCSS sub-investigator if the principal investigator is not CCSS staff).
    • CCSS forms AP-IA to AP-VA: application with the service head’s and medical director’s no-objection signatures for each hospital, protocol, protocol summary, lab and pathology tests, and budget.
    • Investigator’s brochure in the original language plus an official Spanish translation, and the case report form.
    • IDE (or equivalent) or an FDA, EMA or other recognized approval letter; the device’s classification by a recognized agency; Costa Rican registration certificates if the device is already registered.
    • List of countries and sites with expected enrollment per site; approval by an accredited committee in the sponsor’s country if it has sites there; history of submissions to other Costa Rican committees.
    • GMP evidence and, for sterile devices, a sterility certificate.
    • Site licences, sample-transfer agreements, external-lab licences, and recruitment materials.
    • Spanish informed consent (and assent if needed), dated and versioned.
    • For every team member: signed CV, ID, professional licence, a CONIS-endorsed GCP certificate under three years old, CONIS accreditation, and signed commitments and conflict-of-interest declarations.
    • From the sponsor: proof of payment of the review fee; certification that the sponsor is current with CCSS social-security contributions; the investigator-sponsor contract covering all study costs; injury compensation with a policy valid at least two years after the study ends; liability insurance for the investigator and team; free post-study treatment where shown beneficial (Ley 9234 arts. 28 and 53); commitments to report final results and to involve the investigator in publication; and a sworn statement on any CRO or site-management company involved, with its CONIS accreditation.

    Fees for the second half of 2026 (CENDEISSS tariffs; they include 25% administrative costs and are paid by SICO voucher or bank transfer after requesting the payment form from the AISSS):

    Request Fee
    First review ₡1,442,664
    Amendment ₡52,454
    Annual renewal ₡849,663

    CENDEISSS states that committee review takes two to four weeks from receipt of a complete submission. It does not publish how long the sign-offs, contract and cost steps take in practice.

    How long does a CCSS approval take? On paper, the regulation’s own deadlines add up to roughly three months after a complete submission. That excludes dossier preparation, the director’s sign-off, query cycles, corporate paperwork and CONIS registration. The CCSS does not publish actual approval times, and neither does any public source we found, so plan for materially longer than a private site and ask the hospital for its recent track record. CENDEISSS itself states that committee review takes two to four weeks from receipt of a complete submission; the institutional steps around it are what add time. For context, no new clinical trials could start in Costa Rica from February 2010, when the Constitutional Court required a law, until Ley 9234 in April 2014, and until the CCSS adopted this regulation in March 2021 trials could only run in the private sector (Salud y Fármacos, 2020 report).

    Where industry-funded trials actually run in Costa Rica

    We queried the ClinicalTrials.gov API on 28 October 2026 for interventional studies with an industry lead sponsor and at least one site in Costa Rica, then classified each named Costa Rican site as CCSS/public or private:

    • 185 industry-funded interventional studies list a Costa Rican site. 84 name at least one identifiable site; the rest show only placeholders such as “Pfizer Investigational Site”.
    • None of the 84 lists a CCSS hospital or clinic. Named sites are private hospitals and research centers such as CIMCA, ICIMED, Hospital Clínica Bíblica, Hospital Metropolitano, Hospital CIMA, Clínica 20/20 and Policlínico San Bosco.
    • Of the 68 started in 2016 or later, 62 name a site, and none is at a CCSS facility.
    • All 16 industry-funded device studies (all started 2020 or later) are at private sites.
    • The same search across all funders does find CCSS hospitals (Hospital México, San Juan de Dios, Calderón Guardia) in 6 studies, all sponsored by the CCSS, universities or research networks, so the method does pick up public sites when they are listed.

    Caveats: ClinicalTrials.gov does not capture every study approved in Costa Rica, older records often hide site names, and our public/private split is based on facility names. It is a snapshot of where sponsors have registered their Costa Rican sites, not an official count.

    Method. One ClinicalTrials.gov API v2 query per country, using AREA[LocationCountry], AREA[LeadSponsorClass]INDUSTRY and AREA[StudyType]INTERVENTIONAL, pulled on 28 October 2026. For each study we kept only sites in that country, set aside placeholder names (for example “Research Site” or “Investigational Site Number…”), and classified the rest as public or private by facility name. Public means a social-security, ministry, national-institute, public-university or other state hospital or clinic (in Costa Rica, the CCSS network). “Device” means at least one intervention of type Device. “Since 2016” uses the study start date.

    Public versus private sites in nearby countries

    The same method applied to four other countries. The figures show the share of studies that name a site and have at least one public site:

    Country Industry interventional studies With a named site With at least one public site Since 2016: with a public site Device studies: with a public site
    Costa Rica 185 84 0 (0%) 0 of 62 (0%) 0 of 16 (0%)
    Panama 290 150 18 (12%) 9 of 83 (11%) 1 of 35 (3%)
    Colombia 1,359 700 76 (11%)* 55 of 476 (12%)* 1 of 48 (2%)*
    Chile 1,819 900 292 (32%) 170 of 633 (27%) 24 of 79 (30%)
    Mexico 3,635 1,772 806 (45%) 531 of 1,215 (44%) 36 of 102 (35%)

    In short, public sites are rare for industry-funded trials in Costa Rica, Panama and Colombia, and more common in Mexico and Chile, where national institutes, social-security hospitals and public university hospitals often take part. Caveats: name-based classification is approximate; *Colombia’s public hospitals have many naming patterns, so its figures are a lower bound; placeholder site names hide a large share of older records in every country; and the registry does not capture every study approved locally.

    Published sources on public-sector research in Costa Rica

    • The 2010–2014 halt. In 2010 the Constitutional Court (ruling 2010-1668) annulled the decree that regulated research on humans and suspended new studies until a law was passed. Ley 9234 was approved in April 2014 and its regulation (Decreto 39061-S) was published in July 2015. Source: Homedes N. and Ugalde A., “Costa Rica: Los Comités de Ética y la Protección de los Participantes en Investigación Biomédica,” Salud y Fármacos, December 2020.
    • Private sector only until 2021. The same report states that, as of November 2020, clinical trials could only be done in the private sector because the CCSS had not yet approved its internal regulation. It also documents that the CCSS reviewed sponsored interventional studies through a central committee from 2005 on.
    • The CCSS regulation. The CCSS Reglamento de Investigación Biomédica was published on 10 March 2021 and is the current framework (see above).
    • CENDEISSS research staffing. Semanario Universidad (6 November 2024) reported that on 6 June 2023 the CCSS board withdrew authorization to use vacant resident positions to support research at CENDEISSS. A later internal audit found no irregularities and warned that the withdrawal affected ongoing research projects.
    • Size of the sector. El Financiero (14 May 2022) reported about 200 studies in the private sector and more than 400 in the public sector, and that industry groups were then working to make the contract and financial steps of the CCSS regulation operational. The article does not say how many of the public-sector studies were industry-funded clinical trials; most are likely academic or observational. We found no official count of industry-funded trials approved by the CCSS since 2021.

    CONIS-accredited private and university ethics committees

    A private site normally uses its own CEC or any other CONIS-accredited CEC. These are the non-CCSS, non-government committees on CONIS’s accredited list as of 28 October 2026. Fees and calendars change; confirm with the committee before you budget. Where a committee does not publish an item, we say so.

    Committee Type Published requirements Published fees Meetings / turnaround Contact (per CONIS and the committee)
    CEC Hospital Clínica Bíblica Private hospital Not published online Not published Not published Dra. Jessie Orlich Montejo; (506) 2522-1000 ext. 8116; investigacionhcb@clinicabiblica.com (CEC notice)
    CEC-UCIMED (Universidad de Ciencias Médicas) Private university; founded 2002 Online submission platform and full form set for interventional studies, including the CONIS 3% calculation form (CEC-UCIMED) Tariff document linked; amount not shown on the page Not published Dr. José Pablo Díaz Madriz; cec@ucimed.com; (506) 2291-6754
    CEC-UH (Universidad Hispanoamericana) Private university Procedures, forms and checklist; submit by email (CEC-UH) Interventional (2024 tariff): first review US$2,200 (US$2,486 with VAT); renewal US$1,150, protocol amendment US$350 and each additional site US$2,000 (before VAT). Pay within 7 business days of submission (tariff) Sessions in the first week of each month; review within 30 calendar days Dr. Francisco Rodríguez Fallas; cecuh@uh.ac.cr; (506) 2106-3199
    CEC-UNIBE (Universidad Iberoamericana) Private university; since 2008 Submission checklist and forms posted (CEC-UNIBE) Not found online Not confirmed Lic. David Torres Fernández; (506) 2240-0400 ext. 2203
    CEC-ULatina (Universidad Latina) Private university Accepts phase II, III and IV studies only; separate requirement guides for observational and interventional studies (CEC-ULatina) Published list (fees): interventional protocol amendment ₡196,000 (₡252,000 with consent changes); observational first review ₡1,064,000. No interventional first-review fee is shown Monthly. The page gives both “second Monday” and “last Wednesday, 2 p.m.”; documents are due by noon the Wednesday before the session Dr. Norbel Román Garita; cec.ulatina@ulatina.cr; (506) 2207-6017 ext. 16024
    CEC-USP (Universidad Santa Paula) Private university Requirements list and FO-05 checklist (CEC-USP) Fee schedule referenced, not online File at least 7 business days before an ordinary session; three reviewers have 10 business days Dra. Marlene Roselló Araya; (506) 2216-4400
    CEC Fundación INCIENSA (FUNIN) Foundation linked to the public INCIENSA institute Nothing found online Not published Not published Dr. Alejandro Calderón Céspedes; (506) 2668-1125 ext. 1348

    None of these committees states publicly whether it reviews device first-in-human studies. Ley 9234 reserves Phase I approval to the Ministry of Health’s committee (CEC-MS), and the law defines phases in drug terms, so confirm in writing with CONIS or the committee how a device first-in-human study will be routed. Public universities (UCR, UNA), INCIENSA, the Ministry of Health and CCSS hospitals also have accredited committees; they are not listed here.

    Hospital CIMA and Hospital Metropolitano do not appear on the current CONIS list, so studies at those hospitals go to another accredited CEC.

    Step-by-step timeline

    Step Who Published clock What to plan for
    1. Site, CEC and Phase I routing Sponsor, CRO, site None Get the CEC choice (or CEC-MS routing) confirmed in writing
    2. Spanish package, translations, contract, budget Sponsor, CRO, PI None Usually the longest controllable step
    3. Costa Rica–enforceable insurance Sponsor, local broker None Start early; the consent form depends on it
    4. CEC review Accredited CEC 1 calendar month (Decreto 39061-S art. 42); CCSS 30 days full review (CCSS art. 17) Add at least one query cycle and the committee’s session calendar
    5. CONIS registration and 3% levy PI Not published Confirm the current procedure with CONIS
    6. Institutional authorization Site; CCSS offices at public sites Private: none. CCSS: contract 10+5+5 business days, costs up to 30 days, start 5 business days CCSS adds the director sign-off before review plus contracting and cost steps
    7. Device import Importer, CONIS Not published Only after steps 4 and 5; quantity list approved by the CEC
    8. Site initiation and first patient Sponsor, CRO, site None Only once steps 4–7 are complete

    For a week-by-week planning view at a private site, see our Costa Rica FIH activation calendar.

    Document checklist

    • Cover letter from the PI requesting review
    • Protocol and investigator’s brochure, original plus official Spanish translation
    • Spanish informed consent describing the insurance policy
    • IDE or equivalent, or FDA/EMA/other agency approval letter (or CONIS exception)
    • Device classification, GMP evidence and sterility certificate
    • Investigator–sponsor contract and full study budget
    • Costa Rica–enforceable insurance policies and sponsor indemnity commitments
    • Post-trial access commitment
    • CVs, IDs, professional licenses, GCP certificates and CONIS accreditations for the team
    • Site description and habilitation certificate
    • Recruitment materials and the emergency and adverse-event plan
    • CRO/OAC sworn statement and accreditations
    • Investigational device quantity list for CONIS (before import)
    • At CCSS sites: director and service-head no-objection, CCSS co-investigator, CCSS fee receipt, corporate and origin-of-funds documents, CCSS contract

    Using Costa Rica data with the FDA

    If the data will support a U.S. submission, 21 CFR 812.28 lets FDA accept a foreign clinical investigation not conducted under an IDE if it followed good clinical practice, including review and approval by an independent ethics committee and informed consent, and if FDA can validate the data through an on-site inspection if needed (eCFR). A CONIS-accredited CEC approval and an ISO 14155-compliant conduct plan are how most sponsors meet that standard.

    FAQ

    Who sets the requirements for my study?
    The law and regulation set the minimum. The CEC that reviews your protocol applies them and adds its own forms, fees and calendar. If you already work with specific hospitals, ask their committee what it needs.

    Do I pay the Ministry of Health?
    The 3% levy on the total study budget is paid to CONIS, which sits under the Ministry of Health, when the approved study is registered. CEC review fees are separate and set by each committee.

    Do I need a U.S. IDE first?
    The submission package asks for an IDE or equivalent, or an approval letter from FDA, EMA or another recognized agency, unless CONIS grants a qualified exception. Discuss your situation with the committee early.

    Is a public CCSS hospital slower than a private one?
    It has more steps: director sign-off, a central CCSS committee, cost setting and a CCSS contract. No public data on actual durations exists, so plan for longer and ask the hospital.

    Does the device have to be registered in Costa Rica?
    No. Unregistered products may be imported and used for properly approved and registered research.

    Related guides

    How bioaccess® helps

    bioaccess® runs first-in-human and early feasibility device studies in Costa Rica and across Latin America. We assemble the Spanish package, line up the CEC, insurance and CONIS steps, and manage import and site activation so the regulatory clocks start on a complete file.

    Contact bioaccess®

    Last verified: 28 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.

  • Costa Rica Clinical Trial Insurance Under Ley 9234: Enforceable Locally, With a Legal Tail

    General information, not legal or insurance advice. Confirm with the scientific ethics committee (CEC), CONIS and a broker licensed in Costa Rica.

    Costa Rica has one of the most detailed clinical trial insurance regimes in Latin America. Its rules spell out who must be insured, for how long, where the policy must be enforceable, and how fast the insurer must pay.

    Key takeaways

    • A civil liability policy is mandatory for clinical research (Ley 9234, art. 31).
    • It must be valid and enforceable in Costa Rica, and the insurer must have branches or service centers in the country (Reglamento 39061-S, art. 14(f)).
    • Term: from the start of the research until at least two years after it ends, and for each participant from consent signature until three years after their participation ends.
    • The sponsor must also cover the investigator and team, and the PI must hold their own policy.
    • Every participant receives proof or a copy of the policy with the consent form.
    • Insurers must pay within 30 days of receiving complete documentation.

    What the law says

    Ley 9234, the Biomedical Research Law:
    – Art. 31: clinical research must be covered by a civil liability policy protecting participants from damage arising from the research, for the duration of the research and for at least two years after the participant’s participation ends. Policies must follow the principle of proportionality and the dignity of human life, and must be enforceable in the country. The CEC evaluates the policy and sets its term starting from that minimum.
    – Art. 32: with the consent form, each participant receives proof or a copy of the policy showing its number, issuer, term of protection, conditions and claim procedure.
    – Art. 11(f): the consent form for clinical research must address the insurance policy.

    What the regulation adds (Decreto 39061-S)

    Art. 14 sets out the policy requirements:
    – (a) The sponsor’s policy runs from the start of the research until at least two years after the research ends. The research is treated as ended when the final report is delivered to the CEC.
    – (b) Each participant is covered from their consent signature until three years after their participation ends.
    – (c) The CEC checks that the policy’s legal coverage period is at least two years.
    – (d) The sponsor must provide legal coverage and a civil liability policy for the investigator and team for claims attributable to the research, except negligence, malpractice or protocol violations.
    – (e) The PI must hold their own civil liability policy for the cases excluded in (d).
    – (f) Every policy must be valid and enforceable in Costa Rica. Sponsors, PIs and CRO-type organizations must make sure their insurers have branches or service centers in the country, so that participants can actually exercise their rights.

    Art. 15 covers claims:
    – the PI explains to the CEC how participants will understand and use their rights
    – the consent form explains how to access benefits under the insurer’s procedures
    – insurers deliver funds within 30 days of complete documentation, and may make advances for immediate expenses
    – CONIS reports non-compliance to SUGESE, the insurance regulator, for sanctions

    Art. 16 says disputes over insurance benefits follow Ley 8956 on insurance contracts.

    Note that Ley 9234 art. 31 counts the two years from the end of each participant’s participation, while Reglamento art. 14(a) counts them from the end of the study. Plan for the longer period, and confirm with the CEC.

    Planning implications for foreign sponsors

    1. A worldwide certificate alone is unlikely to work. The test is enforceability in Costa Rica through an insurer with a local service presence. Ask your broker for a Costa Rica solution early.
    2. Budget for the tail. The policy period extends years beyond last-patient-last-visit.
    3. Three policies may be involved: the sponsor’s trial policy, the sponsor-provided cover for the investigator and team, and the PI’s own policy.
    4. Prepare the participant copy. Each participant needs the policy proof, so build it into the consent form packet.
    5. The protocol comes first. The CEC evaluates the policy against the specific study.

    Related guides

    How bioaccess® helps

    Costa Rica is a core market for us. We line up the protocol, consent form and CEC requirements with your broker so the policy package passes review the first time. We don’t sell insurance.

    Contact bioaccess®

    FAQ

    Is there a minimum coverage amount in Costa Rica?
    Neither Ley 9234 nor Decreto 39061-S sets a monetary minimum. The CEC evaluates the policy and its term.

    Does the policy have to come from a Costa Rican insurer?
    The rule is that it must be valid and enforceable in Costa Rica, with the insurer having branches or service centers in the country. Confirm the structure with a broker licensed in Costa Rica.

    Does the rule apply to device trials?
    Yes. The regulation (Decreto 39061-S) applies to all biomedical research in Costa Rica (art. 2), and art. 14(a) requires a policy from the sponsor of “toda investigación biomédica”. The regulation also defines medical devices and asks device studies to file the IDE or equivalent and the device’s risk classification.

    Last verified: 29 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.

  • Mexico Clinical Trial Insurance After COFEPRIS’s 2025 Simplification: The 15-Business-Day Rule

    General information, not legal or insurance advice. Confirm current requirements with COFEPRIS, your ethics committee and a broker.

    Many sponsors still treat Mexican study insurance as something that must be in the protocol application. That was true before 2025. Under COFEPRIS’s simplification Acuerdo, the policy now comes after authorization, on a short clock.

    Key takeaways

    • The rule: within 15 business days after the protocol is authorized, file (1) the ethics-approved consent form, (2) the study insurance (policy or certificate) or a current financial fund covering participants, and (3) the emergency-care form and agreement.
    • The penalty: authorizations without this complete information can be revoked, and the applicant has to file again.
    • The exemption: no-risk observational studies don’t file the insurance or emergency-care items.
    • The alternative: Mexico accepts a financial fund instead of an insurance policy, as it already did under NOM-012-SSA3-2012.

    What the rule says

    The Acuerdo por el que se establecen acciones de simplificación para trámites que se realizan ante la COFEPRIS was signed on 24 April 2025 and published in the Diario Oficial de la Federación on 28 April 2025 (text). It does three things that matter here.

    • It removes the insurance from the initial application. Article 1 lists the requirements removed from protocol authorization (COFEPRIS-04-010). That list includes “Seguro del estudio (Póliza/Certificado) o fondo financiero vigente que acredite la cobertura al sujeto de investigación”.
    • It adds the post-authorization step. Article 5 requires the applicant, once the protocol is authorized, to file the consent form, the insurance or fund, and the emergency-care documents within 15 business days. Missing or incorrect information is grounds for revocation.
    • It adds a sworn statement. The new Formato Único del Patrocinador includes a declaration that the sponsor will file these documents after authorization.

    The Acuerdo also gives COFEPRIS a maximum of 30 calendar days to resolve these procedures.

    The underlying obligation hasn’t changed

    NOM-012-SSA3-2012 still applies:
    – §5.14: the research budget must include a financial fund and mechanisms that guarantee continued treatment and the compensation the participant is legally owed for directly related damage. That fund may be covered by the study insurance.
    – §7.2: the institution, committees, PI and, where applicable, sponsor are responsible for health damage arising from the research.
    – §10.6: the consent form must state the participant’s right to compensation and to free medical treatment, even if they withdraw.

    What the policy or fund should show

    According to NIH ClinRegs, earlier COFEPRIS guidance said the policy or fund document must:
    – cover all study participants locally
    – be in the name of the license holder and the sponsor
    – show the number of participants, the study title and the protocol number

    ClinRegs notes that COFEPRIS hadn’t yet updated that guidance to match the 2025 Acuerdo, so treat it as the expected minimum.

    Planning implications

    1. Don’t wait for authorization to start the insurance. Fifteen business days is short for a new multi-country placement. Get a quote on the near-final protocol and be ready to bind as soon as COFEPRIS authorizes.
    2. Keep the consent form and policy consistent. The consent form you file must be the ethics-approved version and must match NOM-012’s compensation language.
    3. Decide early between a policy and a fund. A fund is allowed, but it has to be “vigente” (current) and has to show coverage for participants. Most foreign sponsors use a policy. Discuss this with counsel.
    4. Amendments can trigger it again. A change of sponsor (modality J of COFEPRIS-09-012) requires the policy or fund again.
    5. Local insurer. COFEPRIS’s rules don’t address it, but Mexico’s Ley de Instituciones de Seguros y de Fianzas does. Art. 21 IV prohibits buying liability insurance for events that can occur in Mexico from a foreign insurer, and art. 21 I(b) does the same for insurance of persons that a company buys for people resident in Mexico. The CNSF can grant an exception when no authorized Mexican insurer can or will write the risk (art. 22 II), and contracts that breach art. 21 have no legal effect (art. 24).

    Related guides

    How bioaccess® helps

    We plan the COFEPRIS filing and the 15-day post-authorization package together, and coordinate with your broker so the certificate matches the protocol and participant numbers. We’re not an insurer.

    Contact bioaccess®

    FAQ

    Is insurance still mandatory in Mexico?
    Yes, insurance or a current financial fund, except for no-risk observational studies. Only the timing changed: it’s now filed after authorization.

    What happens if I miss the 15 business days?
    Under Article 5 of the Acuerdo, authorizations without the complete information can be revoked, and you’d have to file again.

    Does this apply to device studies?
    Yes. The Acuerdo merged the drug, bioequivalence, “nuevos recursos” (which includes devices and procedures) and no-risk modalities into a single procedure, COFEPRIS-04-010.

    Is there a minimum limit?
    No minimum is set in the Acuerdo or NOM-012. Limits come from contracts, ethics review and underwriting.

    Last verified: 29 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.

  • What Insurers Need Before They’ll Quote a Clinical Trial Policy (and Why You Can’t Insure a Study That Doesn’t Exist Yet)

    General information, not insurance advice. bioaccess® is a CRO. We don’t sell or underwrite insurance.

    A common stall in early study planning goes like this. A sponsor wants the insurance sorted before it commits to a CRO, a country or a final protocol. It calls a broker, the broker asks for the protocol, and everything stops.

    That isn’t the broker being difficult. Clinical trial liability insurance is written for one specific study. The insurer is pricing the chance that a defined product, used in a defined way, on a defined number of people, in defined countries, for a defined time, injures someone. Until those things are written down, there’s nothing to price.

    Key takeaways

    • No protocol, no policy. Insurers underwrite the study described in the protocol. Some brokers will quote from a near-final draft. A pitch deck or a one-line study description isn’t enough.
    • The certificate names the study. In Mexico (per NIH ClinRegs) and at some Chilean ethics committees (for example CEC Salud UC), the policy or certificate must identify the protocol and, in Mexico, the number of participants.
    • There’s a circular dependency. In Peru, Costa Rica and Argentina the consent form must contain the policy or insurer details. So you need the protocol to get the policy, and the policy to finish the consent form.
    • Start early, but in the right order. Countries, then protocol, then quote, then consent form, then certificate, then ethics submission.

    Why the protocol comes first

    The protocol defines every variable an underwriter prices:

    • What’s being tested. Drug, biologic or device; implantable or not; first-in-human or not; prior human data.
    • How it’s used. Dose or procedure, invasiveness, exposure duration, comparator or placebo.
    • On whom. Patients or healthy volunteers, age range, vulnerable groups, pregnancy exclusions.
    • How many and where. Enrollment overall and by country, number of sites, named institutions.
    • For how long. Start date, treatment period, follow-up, and expected final report. These drive the policy period and any required tail.

    Regulators then tie the policy to that study. Mexican guidance, as summarized by NIH ClinRegs, says the policy and certificate must state the number of participants, the study title and the protocol number. COFEPRIS’s single sponsor form, introduced in April 2025, asks for:
    – the Mexican sample size and the global number of participants
    – the number of Mexican sites
    – study start and end dates
    – the risk level

    These are the same facts an insurer needs.

    The document checklist

    Brokers and insurers vary, but this is what you should expect to provide. The Willis clinical trial submission platform, for example, asks for a completed quote request plus the protocol and the informed consent forms, and recommends submitting a complete request at least two weeks before you need the certificate. Marsh notes that a draft protocol is acceptable for a quote, because later changes are usually minor.

    About the study
    1. Protocol, or near-final draft: title, number, version, phase or stage, design, endpoints, procedures, risk level
    2. Investigator’s Brochure, or the device equivalent: preclinical, bench and biocompatibility data and prior human experience
    3. Informed consent form, or at least the injury, compensation and insurance section
    4. Synopsis showing enrollment by country and overall, participant population and inclusion/exclusion criteria

    About where and when

    1. Country list and number of sites. Include named sites and PIs if known, because these are needed for additional-insured endorsements.
    2. Timeline: first participant in, last participant out, follow-up duration, and final report date

    About the sponsor

    1. Legal entity, address and ownership. Some markets have know-your-customer checks.
    2. Existing master, product liability or clinical trial program, and its territory clause
    3. Contract requirements from sites and CROs, such as additional insureds and limits

    About each country

    1. The local requirement, such as an in-country insurer, a policy term, or consent form wording. See our pillar guide, Clinical trial liability insurance in Latin America: requirements by country.

    The consent-form loop

    In several countries the consent form can’t be finished until the policy exists:

    • Peru: the policy’s in-country coverage, and the local representative if the insurer is foreign, must be stated in the consent form (DS 021-2017-SA, art. 28).
    • Costa Rica: each participant receives proof or a copy of the policy showing its number, issuer, term, conditions and claim procedure (Ley 9234, art. 32).
    • Argentina: the consent form names the insurance company and its address (ANMAT Disp. 7516/2025, Appendix D).

    The practical answer is to request quotes on the near-final protocol. Draft the consent form with placeholders for the policy number and insurer, and fill them in once the policy is bound, before the ethics submission.

    A workable sequence

    1. Choose countries based on the product’s regulatory pathway and enrollment, not on insurance.
    2. Freeze the protocol design. Enrollment, sites and duration should be stable.
    3. Brief the broker with the checklist above, and ask which countries need locally admitted paper.
    4. Get quotes for a master policy plus local policies where needed.
    5. Bind and get certificates and endorsements naming the protocol, sites and PIs.
    6. Finish the consent forms with the policy details.
    7. Submit to ethics and regulators. In Mexico, file the policy or fund within 15 business days after COFEPRIS authorization.

    Common mistakes

    • Asking for a quote on a “platform” or a pipeline. Underwriters price a study, not a company.
    • Relying on a US product liability policy whose territory clause excludes research outside the US, or which a Latin American committee won’t accept as local cover.
    • Choosing a site because “it has insurance”. A hospital’s own malpractice cover isn’t the sponsor’s trial policy.
    • Letting the policy expire at last-patient-last-visit. Costa Rica and Peru require cover beyond that.

    Related guides

    How bioaccess® helps

    We assemble the protocol package, country plan and consent form drafts that insurers ask for. We coordinate with your broker so certificates match each ethics committee’s checklist, and we keep the timeline realistic. We don’t sell insurance.

    Contact bioaccess®

    FAQ

    Can I get clinical trial insurance before choosing a CRO?
    Yes. The CRO doesn’t drive the quote, the protocol does. But you need the protocol, the countries and a realistic enrollment and timeline.

    Will an insurer accept a synopsis instead of a full protocol?
    Some brokers will give an indication from a detailed synopsis. Binding and certificate issuance generally need the protocol, and some platforms also ask for the consent form.

    Do I need a separate policy for each country?
    Often, for countries that require locally admitted or in-country cover. Examples are Argentina (“seguro constituido en el país”), Peru (coverage in Peru) and Costa Rica (enforceable locally). A master policy can sit above the local policies.

    How far in advance should I start?
    Begin broker conversations once the protocol design is stable. Willis recommends submitting a complete request at least two weeks before the certificate is needed. Allow more time for multi-country programs and local policies.

    What if the protocol changes after binding?
    Tell the broker. Changes to enrollment, countries, sites or duration usually require an endorsement, and some regulators require the policy again for certain amendments. Mexico, for example, requires it for a change of sponsor.

    Last verified: 29 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.

  • Clinical Trial Liability Insurance in Latin America: Requirements by Country for Foreign Sponsors

    General information, not legal or insurance advice. Rules change. Confirm the current requirement with the reviewing ethics committee, the health authority and a broker licensed in each country before you rely on it. bioaccess® is a CRO. We don’t sell, underwrite or bind insurance.

    If you’re a US or other foreign sponsor planning a study in Latin America, insurance will come up early. It also tends to come up in the wrong order. Sponsors often try to buy a policy before they have a protocol, or assume the US product-liability policy they already hold will satisfy an ethics committee in Lima or San José.

    This guide covers what the law actually says in the main Latin American markets. For each country we answer five questions: is insurance mandatory, which rule requires it, does the policy have to sit with a local insurer, what term or minimum applies, and when in the submission you need it. Every cell in the comparison table cites the rule it comes from, with a link to the official text. Where a law is silent on a point, we say the law is silent rather than guess.

    Key takeaways

    • Most of the region requires it, but not in the same way. Peru, Costa Rica, Argentina (drug trials), Chile, Guatemala and Mexico have written requirements. Colombia, the Dominican Republic and El Salvador put the policy on the ethics or submission checklist. Brazil’s 2024 law imposes an indemnity duty on the sponsor but doesn’t require a policy in the statute. Panama’s 2026 decree requires financial provisions for compensation.
    • “Local” matters. Argentina requires a policy “constituted in the country”. Peru requires coverage in Peru, and a foreign insurer must have a legal representative there. Costa Rica requires a policy that is “valid and enforceable” in Costa Rica from an insurer with a branch or service center in the country. Separately, the general insurance laws of Mexico, Brazil, Chile, Colombia, Panama and the Dominican Republic limit cover bought from insurers that aren’t authorized in the country; how far those limits reach a trial policy bought abroad is a question for a local broker. A worldwide master certificate on its own often won’t satisfy the reviewer.
    • The policy follows the protocol, not the other way around. Insurers price a specific study: its design, risk, number of participants, countries, sites and duration. In Mexico (per NIH ClinRegs) and at some Chilean ethics committees, the policy must identify the study. Without a protocol there’s nothing to underwrite.
    • Tail periods are written into statute or regulation in some countries. Costa Rica requires cover for at least two years after the final report is delivered to the ethics committee, and three years after each participant’s participation ends. Peru requires the policy to run until the National Final Report and to be renewed while late damages are possible.
    • Mexico changed the sequence in 2025. COFEPRIS now authorizes the protocol first. The sponsor then has 15 business days to file the policy or a financial fund, or the authorization can be revoked. That changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve.

    Why Latin American rules differ from what US sponsors expect

    In the United States no federal rule requires clinical trial insurance. Coverage is usually driven by site and CRO contracts. Much of Latin America works differently: participant-injury protection is written into health regulation, ethics committees check the policy as part of approval, and several countries’ general insurance laws limit cover placed with insurers that aren’t authorized locally.

    There’s also a liability point. Several countries make the sponsor responsible for trial-related injury whether or not anyone was at fault, and regardless of what the policy pays:

    • Chile: the holder of the investigational-use authorization is liable even for damage that couldn’t have been foreseen. Once damage is shown, causation by the trial is presumed, and the limitation period is ten years from when the damage appears (Código Sanitario art. 111 E).
    • Guatemala: if the policy doesn’t cover the full damage, the sponsor is liable for the rest without any need to show fault (Acuerdo Ministerial 82-2019, §11.4).
    • Peru: the sponsor’s duty to compensate is independent of the policy’s validity or limits (DS 021-2017-SA, art. 29).

    So the policy is how the sponsor proves it can pay for that duty. It doesn’t replace the duty.

    Country comparison table

    Country Insurance mandatory? Legal basis Local insurer or local policy? Term or minimum in the rule When it’s needed
    Brazil Sponsor must indemnify; the statute has no insurance mandate Lei 14.874/2024, arts. 23, 26 XV Yes for Brazil-domiciled buyers: cover for risks in Brazil must be placed in Brazil, with narrow exceptions (Lei Complementar 126/2007, arts. 19–20) None in the statute Not fixed by the statute. CEP/Conep ethics review doesn’t ask for proof of insurance (CONEP manual, 2015), so any timing comes from site contracts
    Mexico Yes: insurance or a financial fund COFEPRIS Acuerdo of 24 Apr 2025, art. 5; NOM-012-SSA3-2012 §5.14 Yes: liability cover for events that can occur in Mexico may not be bought from a foreign insurer unless the CNSF grants an exception (Ley de Instituciones de Seguros y de Fianzas, arts. 21 IV, 22, 24) None in the rule COFEPRIS: within 15 business days after protocol authorization. Ethics committees may ask for it before they approve
    Colombia On the GCP ethics and sponsor checklists (drugs); INVIMA also checks for a policy in device studies Res. 2378/2008, Technical Annex; Res. 8430/1993, art. 13; INVIMA device-study inspection tool No trial-specific rule. Foreign insurers may not sell cover in Colombia; residents may buy abroad except mandatory insurance (EOSF art. 39, as amended by Ley 1328/2009, art. 61) Value “according to international standards” (Res. 2378); no amount or term In the ethics file before approval
    Argentina Yes for national drug trials for registration. Buenos Aires City requires insurance or another financial guarantee for research there; Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved ANMAT Disp. 7516/2025, Annex II §3.14; CABA Ley 3301, art. 12; Buenos Aires Province Decreto 3389/2024, art. 8 Yes (drug trials): “seguro constituido en el país”. Buenos Aires Province: insurer recognized by the national insurance regulator (SSN) No national minimum. Buenos Aires Province: at least 1 year after the study ends. Buenos Aires City: through the civil-code limitation period Before the study starts; insurer named in the consent form
    Chile Yes, for drugs; for devices, in the classes a decree is to set (not yet issued) Código Sanitario arts. 111 A and 111 F; DS 114/2010, art. 25 (as amended by DS 30/2012) On our reading, art. 111 F makes this a legally required insurance, which would bring it within DFL 251, art. 4 (insurers established in Chile). We found no CMF or ISP ruling, and Hospital Clínico U. de Chile asks industry sponsors to name their representative in Chile rather than a Chilean insurer. Confirm with a Chilean broker None in the statute. Claims can be brought for 10 years (art. 111 E). CEC Salud UC requires cover through formal closure Filed with the ISP authorization request, after ethics approval (art. 111 A)
    Peru Yes, plus a financial fund DS 021-2017-SA, art. 28 Coverage in Peru; foreign insurer needs a legal representative in Peru Until the National Final Report, then renewed while late damage is possible Before authorization; details in the consent form
    Costa Rica Yes Ley 9234, art. 31; Reglamento 39061-S, art. 14 Enforceable in Costa Rica; insurer with a branch or service center in the country Decreto 39061-S art. 14: at least 2 years after the final report is delivered to the CEC, and 3 years after each participant’s participation ends. Ley 9234 art. 31 floor: 2 years after participation ends Ethics review before start; each participant gets proof of the policy
    Panama Sponsor “financial provisions” required Decreto Ejecutivo 21/2026, art. 67(2) On our reading, yes for Panama-domiciled buyers: insurance on people and property in Panama must come from locally authorized insurers, unless the cover isn’t available or is declined locally (Ley 12 de 2012, art. 153) None in the decree Attached to the bioethics submission
    Dominican Republic Yes (submission requirement) CONABIOS requirements (2025) and Manual (12 July 2022) Insurance on people’s life and health must be written in the country by locally authorized insurers; surplus lines are exempt (Ley 146-02, art. 6). Art. 6 lists life, health and property; whether it reaches a trial-liability policy is a question for a local broker None in the CONABIOS rules At submission to CONABIOS
    Guatemala Yes (drug and device trials) Acuerdo Ministerial 82-2019, §§2, 11, 41, 43.8 Insurer established in the country or working with a national insurer (§11.3) Payouts must equal what the sponsor would pay for the same damage in the trial’s country of origin (§11.3) Before the trial starts
    El Salvador Yes, as a CNEIS submission and SRS inspection requirement CNEIS SOP manual (2018); SRS GCP inspection guide (2025) Policy must show how it applies in El Salvador None in the CNEIS or SRS documents With the CNEIS submission; checked at inspection

    How to read the “local insurer” column: where a clinical-trial rule is silent, we cite the country’s general insurance law. Brazil’s, Colombia’s and Panama’s rules bind buyers who are resident or domiciled in the country; Mexico’s is framed by where the event can occur. How these rules apply when a foreign sponsor buys cover abroad is a structuring question for a broker licensed in that country. Every cell was checked against the linked text on 29 October 2026. Where a cell says “on our reading”, it is our interpretation of the text, not an official ruling.

    None of the rules above sets a minimum dollar limit. Limits come from site and CRO contracts and the insurer’s underwriting. None of the ethics-committee rules we read sets a minimum either.

    Country by country

    Brazil

    Legal basis: Lei 14.874/2024, the national law on research with human beings. Art. 23 says participants will be indemnified for damage arising from their participation and will receive related health care, and that the sponsor is responsible for both. Art. 26 XV repeats this among the sponsor’s duties. Art. 26 §3 makes the participating institutions jointly responsible for full care of participants. Art. 18 §3 bars any consent-form language suggesting the participant waives rights or that the sponsor is exempt from liability. Lei 14.874 is regulated by Decreto 12.651 of 7 October 2025, which covers the national ethics system, CEP accreditation, risk classification and post-study access; we found no insurance requirement in it.

    Is a policy mandatory? The statute doesn’t require an insurance policy. It requires the sponsor to pay. Ethics review doesn’t add a policy requirement either (see CONEP’s guidance below). If a policy is bought, Brazil’s insurance law shapes where it is placed. Under Lei Complementar 126/2007, art. 19, insurance bought by people resident in Brazil or companies domiciled there to cover risks in Brazil must be placed in Brazil. Art. 20 allows cover abroad only in narrow cases, such as when no Brazilian insurer offers it. In practice that points to a local policy from an insurer authorized by SUSEP, the federal insurance regulator, when a Brazil-domiciled party buys the cover. Whether it reaches a foreign sponsor buying abroad is a question for a SUSEP-registered broker.

    Ethics-committee practice (CONEP guidance, not law): CONEP, which runs Brazil’s national ethics-review system, says in its Manual de orientação: pendências frequentes em protocolos de pesquisa clínica (version 1.0, 2015) that “O Sistema CEP/Conep não solicita a comprovação da existência de seguro para execução da pesquisa”. It treats indemnity as the duty of the sponsor, investigator and institution whether or not a policy exists. It says indemnity can’t be limited to the amount insured, and that the consent form must not tie the right to indemnity to a policy the sponsor has bought. The manual was issued in 2015 under CNS Resolution 466/2012, before Lei 14.874/2024 and Decreto 12.651/2025. Art. 39 of the decree keeps CNS ethics norms in force, where they don’t conflict with the law or the decree, until the new national ethics body issues its own. We found nothing newer that changes CONEP’s position.

    For device sponsors: the law applies to medical devices “no que couber” (where applicable) (art. 62). ANVISA’s device-trial rule is RDC 837/2023.

    Mexico

    Deep dive: Mexico’s 15-business-day insurance rule.

    Legal basis:

    • NOM-012-SSA3-2012 §5.14: the research budget must include a financial fund and mechanisms to guarantee continued treatment and the compensation a participant is legally owed for directly related damage. That fund “may be covered with the study insurance”.
    • §7.2: the institution, the committees, the PI and, where applicable, the sponsor are responsible for health damage caused by the research.
    • §10.6: the consent form must state the participant’s right to compensation and to free treatment.

    What changed in 2025: COFEPRIS’s simplification Acuerdo (signed 24 April 2025, published in the DOF on 28 April 2025) removed the study insurance from the initial protocol application. Article 5 now requires the applicant to file three things within 15 business days after the protocol is authorized:

    • the ethics-approved consent form
    • the “Seguro del estudio (Póliza/Certificado) o fondo financiero vigente” that covers the participants
    • the emergency-care form and agreement

    Authorizations without this complete information may be revoked. No-risk observational studies are exempt from the insurance and emergency-care items. The sponsor also signs a sworn statement in the new single sponsor form (Formato Único del Patrocinador) committing to file these documents. Changing sponsor (amendment J) requires the policy or fund again.

    Policy content: according to ClinRegs, earlier COFEPRIS guidance said the policy or certificate must be in the name of the license holder and the sponsor, cover all local participants, and show the number of participants, the study title and the protocol number.

    Local insurer: the COFEPRIS rules don’t address it, but Mexico’s insurance law does. Ley de Instituciones de Seguros y de Fianzas art. 21 prohibits buying from foreign insurers both liability insurance for events that can occur in Mexico (fraction IV) and insurance of persons where a company buys it for people resident in Mexico (fraction I(b)). The CNSF can grant an exception when no authorized Mexican insurer can or will write the risk (art. 22 II). Contracts that breach art. 21 have no legal effect (art. 24). In practice, that points to a policy issued by an insurer authorized in Mexico.

    Colombia

    Legal basis: Resolución 2378 de 2008 adopts Good Clinical Practice for institutions running research with medicines. Its Technical Annex lists “Póliza de seguro para los participantes” among the documents the ethics committee reviews and files. The sponsor checklist asks whether the sponsor provides a “póliza contractual y extracontractual para eventos adversos asociados y atribuibles al producto de investigación, cuyo valor estará de acuerdo con estándares internacionales”. In plain terms: contractual and non-contractual liability cover for adverse events attributable to the investigational product, sized to international standards.

    Who and when: the sponsor, before ethics approval.

    Device studies: Res. 2378 is written for medicines. For devices, Resolución 8430 de 1993, art. 13, makes the research institution or sponsor responsible for care of any participant harmed by the research, “sin perjuicio de la indemnización que legalmente le corresponda”. INVIMA’s inspection tool for device clinical research checks that the contract includes a policy, that the policy is in force, and that neither the policy nor the consent form limits the participant’s rights or right to sue.

    Local insurer: no clinical-trial rule requires a Colombian insurer. Colombia’s general insurance law (Estatuto Orgánico del Sistema Financiero, art. 39, as amended by Ley 1328 de 2009, art. 61) bars foreign insurers from selling or advertising cover in Colombia, except marine, aviation and goods-in-transit lines. Residents may buy insurance abroad, except mandatory insurance (“seguros obligatorios”) and a few other categories. The Superintendencia Financiera reads that exception to mean that mandatory cover can’t be bought abroad.

    Ethics-committee practice (not law): Clínica Universidad de La Sabana’s ethics committee (initial-submission requirements, web page, undated) asks for the “Póliza de seguros que cubre el protocolo”. For multinational policies it also asks for a description of the indemnity and coverage arrangements and of how the policy applies locally. Fundación Valle del Lili’s ethics committee lists the “Póliza de Responsabilidad” among the documents reviewed for new pharmaceutical protocols (Circular No. 01, 2026 fees, 6 January 2026). Neither sets an amount.

    Argentina

    Legal basis: ANMAT Disposición 7516/2025. It was published on 9 October 2025, took effect on 1 December 2025, and replaced the 6677/2010 regime. Annex II covers local GCP requirements for clinical pharmacology studies for registration:

    • §3.14.1: the sponsor must ensure medical care and contract insurance “en el país” for harm the study causes to participants. Approval doesn’t exempt the sponsor from legal liability.
    • §3.14.2: a study may only be carried out once the sponsor has contracted a “seguro constituido en el país” to cover the risks or potential damage to participants.
    • §1.2.2(t): the study insurance policy is part of the ethics committee file.
    • Appendix D (consent form): the consent form must name the insurance company and its address. It may not include limiting phrases such as “damages will be covered if you followed the study doctor’s instructions” or “reasonable costs will be covered”.

    Device studies: ANMAT’s device-trial rule, Disposición 969/1997, has no insurance clause. It makes the sponsor bear all study costs (§2.3.6). Local law fills the gap in Argentina’s two largest research hubs:

    • City of Buenos Aires: Ley 3301, art. 12, allows research to proceed only once insurance or another financial guarantee is in place, unless the sponsor is a state body. The sponsor buys it. It must cover the sponsor, PI, team and institution, cover direct and indirect damage, and run after the study for the civil-code limitation period. The participant information sheet that goes with the consent form must name the insurer and policy number (art. 10(p)). The authority may grant exemptions from the insurance requirement (art. 5.1.18).
    • Buenos Aires Province: Decreto 3389/2024 (regulating Ley 15.462), art. 8, requires the health institution to show a care-and-indemnity insurance before a higher-risk (“riesgo mayor”) protocol is approved, plus professional liability cover for the research team. The insurer must be recognized by the Superintendencia de Seguros de la Nación, and cover must last at least one year after the study ends.
    • Córdoba (provincial ethics council rule): the CoEIS, which accredits Córdoba’s institutional research ethics committees under provincial Ley 9694, requires in Disposición CoEIS 44/2023 (28 April 2023), art. 2(e), that pilot studies not intended for national registration present “el Seguro de Responsabilidad Civil para Investigación Clínica según lo establecido en la Disposición CoEIS N°: 37/18”. The rule covers studies of medicines and of “productos médicos” (devices) (art. 3). We could not open Disposición 37/18 itself.

    Chile

    Legal basis: Código Sanitario art. 111 F, added by Ley 20.850. Holders of the special provisional-use authorization for research with pharmaceuticals or medical devices must hold civil liability insurance, under a Ministry of Health regulation. A supreme decree is to set which classes of medical devices require the policy; it hasn’t been issued. Ley 20.120’s regulation (DS 114/2010, art. 25, as amended by DS 30/2012) also requires every protocol for scientific research in human beings under that law to set out “los resguardos necesarios para precaver mediante los seguros y garantías que procedan” the foreseeable and unforeseeable adverse events, which applies to device studies too. Art. 111 E makes the holder liable even for unforeseeable damage, presumes causation once damage is shown, and sets a ten-year limitation period from when the damage manifests.

    What ethics committees ask for: the Health Sciences Ethics Committee of the Pontificia Universidad Católica (CEC Salud UC) issued a statement in March 2025 setting its minimums. The insured must be the authorization holder, the policy must identify the study, it must cover all civil damages related to the research, and it must stay in force until formal closure, including the last follow-up visit.

    Ethics-committee practice in Chile (committee rules, not law)

    With the art. 111 F regulation still pending, we read the published rules of accredited Chilean scientific ethics committees (CECs) on 29 October 2026. Every committee whose rules we could open asks for the policy as a submission document for clinical trials, and several name device trials expressly. None sets a minimum amount.

    • CEC Salud UC (Pontificia Universidad Católica), Declaración sobre pólizas (March 2025): applies to drug, vaccine and medical-device trials. The insured is the authorization holder, the policy names the study and covers all civil damages, and it stays in force through formal closure, including the last follow-up. It must show start and end dates and be current at each annual renewal.
    • Universidad de Chile, Faculty of Medicine CEISH, Reglamento approved by Resolución Exenta 697 (30 October 2024): covers trials of “productos farmacéuticos y dispositivos médicos”; for clinical trials it asks for “la póliza y certificado de seguro”, and its review form includes “compensación por daños / seguro de riesgos”. Its submission checklist (v3.6, 19 June 2025) asks for the insurance certificate.
    • Hospital Clínico Universidad de Chile, requirements for industry-funded studies (March 2026): for studies sponsored by the pharmaceutical industry, a copy of the policy, “señalar quién es el representante en Chile y su vigencia” (name the Chilean representative and the policy period).
    • Clínica Alemana–Universidad del Desarrollo CEC, Reglamento Interno (January 2026): “Póliza de seguros asociados (en caso de ensayos clínicos)” in the submission file; the consent form must state the insurance guarantee for compensation; the committee reviews device and surgical-procedure trials.
    • Clínica Las Condes CEI, Reglamento (v3.0, revised January 2026): “Seguros asociados” among required documents (art. 12) and “previsión de compensación por daños” as a review criterion (art. 14). The committee must protect participants “mediante los seguros o garantías suficientes”, citing standard 10 of MINSAL Norma Técnica 0151.
    • Hospital del Trabajador CEC, committee web page (undated): for trials “con productos farmacéuticos o implantes”, “Póliza de seguro según normativa del ISP”.
    • Universidad Mayor CEC, committee web page (undated; refers to its 2025/2026 forms): “Póliza de Seguros o garantías en idioma español para la realización del ensayo clínico en Chile”. If the policy excludes investigator malpractice, a separate policy covering it is required.

    The binding rule and the accreditation standard behind this: the binding source is DS 114/2010, art. 25 (as amended by DS 30/2012), quoted above. MINSAL Norma Técnica 0151 (Resolución Exenta 403, 11 July 2013; copy hosted by the Servicio de Salud Araucanía Norte), standard 10, restates it for committee accreditation: protocols must state how adverse events will be covered “mediante los seguros y garantías que procedan”. NT 0151 was amended by Resolución Exenta 183/2016, which replaced only standard 9.

    Where practice goes beyond the statute: committees already ask for a policy in device trials although the decree setting device classes under art. 111 F hasn’t been issued; that practice rests partly on DS 114 art. 25, which applies to all research in human beings under Ley 20.120. CEC Salud UC also sets a term (through formal closure) that the statute doesn’t. Universidad Mayor asks for Spanish-language cover for Chile, and the Hospital Clínico asks industry sponsors to name a Chilean representative. We found no published insurance requirements on the official sites of the Metropolitan health-service committees (SSM Oriente, Norte, Sur, Central) or of Clínica MEDS and Clínica INDISA.

    The policy is part of the ISP application: art. 111 A requires the applicant to file the protocol, the consent form and “la póliza de seguros”, after ethics approval, to obtain the ISP’s provisional-use authorization for any unregistered drug or device.

    Local insurer: DFL 251 de 1931, art. 4, lets anyone buy insurance abroad except “los seguros obligatorios establecidos por ley”, which may only be bought from companies established in Chile. On our reading, art. 111 F makes this policy a legally required insurance, which would bring it within that exception. We found no CMF or ISP ruling applying art. 4 to research policies, and Hospital Clínico Universidad de Chile asks industry sponsors to name their representative in Chile rather than requiring a Chilean insurer. The opposite reading is also arguable: art. 111 F leaves the policy’s terms to a regulation that hasn’t been issued. Confirm the structure with a Chilean broker.

    Regulation still pending: art. 111 F leaves the policy’s conditions to a Ministry of Health regulation and the covered device classes to a supreme decree. We found neither in searches of official Chilean sources on 29 October 2026. Until they are issued, the statute itself (arts. 111 A, 111 E and 111 F), DS 114/2010 art. 25 and the ethics committees’ requirements are what apply.

    Peru

    Legal basis: DS 021-2017-SA, the Clinical Trials Regulation.

    • Art. 27: the PI and sponsor provide free care for trial-related injury, and the sponsor must indemnify.
    • Art. 28: the sponsor must contract a policy covering damages to participants. Until the policy pays out, the sponsor must keep a financial fund for immediate free treatment. The policy must have coverage in Peru, and if the insurer is foreign it must have a legal representative in Peru. This information must appear in the consent form. The policy must stay in force until the National Final Report is submitted, and then be renewed while late damage is possible, up to the end of any lawsuit.
    • Art. 29: defines what is compensable, including pregnancy-related damage, and says the sponsor’s duty doesn’t depend on the policy.

    Art. 67(j)–(k): the authorization application must include a copy of the policy in force and the sponsor’s sworn statement that it holds the financial fund for immediate free care until the policy pays.

    Ethics-committee practice (not law): the EsSalud research ethics committee of the Red Asistencial Cusco, in its procedures manual (2024 edition, published by EsSalud’s IETSI), asks clinical-trial submissions for a “copia de la póliza de seguro del patrocinador (copia original y traducida al español certificada por el traductor)”, specifying how it applies in Peru. Its deviation-report form records the policy’s expiry date. It sets no amount.

    Costa Rica

    Deep dive: Costa Rica insurance under Ley 9234.

    Legal basis: Ley 9234, the Biomedical Research Law.

    • Art. 31: clinical research must be covered by a civil liability policy, from the start of the research until at least two years after the participant’s participation ends. The policy must be enforceable in Costa Rica, and the scientific ethics committees (CEC) set its term starting from that minimum.
    • Art. 32: each participant receives proof or a copy of the policy showing its number, issuer, term, conditions and claim procedure.

    Regulation: Decreto 39061-S, art. 14:

    • the sponsor’s policy runs from the start of the study until at least two years after the final report is delivered to the CEC
    • each participant is covered from the signing of the consent form until three years after their participation ends
    • the sponsor must also cover the investigator and team, except for negligence or protocol violations
    • the PI must carry their own civil liability policy
    • insurers must have branches or service centers in Costa Rica

    Under art. 15, insurers must pay within 30 days of receiving complete documentation, and CONIS refers non-compliance to SUGESE, the insurance regulator.

    Panama

    More on the decree: Panama Decreto 21 of 2026: what sponsors need to know.

    Legal basis: Ley 84 de 2019 and Decreto Ejecutivo 21 of 23 April 2026. Art. 61 gives participants the right to the compensation they need for research-related adverse events, “según los estándares del país”. Art. 67(2) requires the investigator to obtain from the sponsor “las previsiones financieras para la compensación efectiva de los posibles daños” and attach that agreement to the CNBI or accredited bioethics committee submission.

    Our reading: the decree requires a documented financial provision. We didn’t find an explicit insurance-policy mandate in its text. A certificate of insurance is the usual way to document that provision, and committees may ask for one.

    Local insurer: Ley 12 de 2012, art. 153, requires entities and people domiciled in Panama to buy insurance on people and property in Panama from insurers authorized there. The exceptions are treaties, cover that doesn’t exist in Panama, and cover that authorized insurers have declined, in which case the Superintendency can authorize placement abroad.

    Dominican Republic

    Basis: the submission checklist of CONABIOS, the national bioethics council, lists “Póliza de seguro para participantes“. Its Manual de Normas y Procedimientos Operativos (12 July 2022) describes this as a civil liability, health or research policy for participants, “as the Council considers appropriate”. The Council also checks the insurance or indemnity that covers the sponsor’s and investigator’s liability.

    Local insurer: CONABIOS doesn’t address it. Ley 146-02 on insurance and bonds, art. 6, requires insurance on the life and health of persons, and on property located in the country, to be written in the Dominican Republic through insurers authorized there. Surplus lines (“líneas excedentes”) are exempt, as are cases where the rule would conflict with a treaty the Dominican Republic has signed. Art. 6 lists life, health and property; whether it reaches a trial-liability policy is a question for a local broker.

    Guatemala

    Basis: Acuerdo Ministerial 82-2019 (MSPAS). It applies to “todo ensayo clínico con un dispositivo o una sustancia” in the investigational phase (§2) and regulates “ensayos clínicos con medicamentos y dispositivos médicos” (§41). The device-trial application must include a “copia de la póliza del seguro del ensayo clínico” (§43.8). Its insurance provisions:

    • §11.1–11.2: a trial of an investigational product, a new indication, or one without therapeutic interest for the participant may begin only after insurance covering all resulting damage is in place. Every participant must be covered for injury, disability and death.
    • §10.2: the policy covers the civil liability of the sponsor, investigators, collaborators and site, and must be documented before the trial starts.
    • §11.3: insurers must be recognized nationally or internationally and either established in Guatemala or working with Guatemalan insurers. Payouts must equal what the sponsor would pay in the trial’s country of origin for the same damage.

    El Salvador

    Basis: the CNEIS submission checklist asks for information on the sponsor’s participant policy, “specifying how it applies in El Salvador”. The trial regulator, the Superintendencia de Regulación Sanitaria (SRS), uses a 2025 GCP inspection guide that checks whether trials hold policies “under current regulation” (item 4.1.8). The CNEIS manual dates from 2018; the guide doesn’t say which regulation it means, and neither document sets a policy term or minimum.

    What every LATAM policy needs to show

    Across these countries, reviewers check the same handful of things:

    1. The study: protocol number and title, and in Mexico the number of participants. A policy can’t be issued for a study that hasn’t been defined.
    2. The insured parties: the sponsor or authorization holder, and often the PI, team and site. Costa Rica and Guatemala write this into the rule.
    3. Territory and enforceability: in-country coverage (Peru), “constituted in the country” (Argentina), or enforceable with a local service presence (Costa Rica).
    4. Period: through the final report and beyond (Costa Rica and Peru), and in Chile at least through closure.
    5. Consent-form alignment: insurer name and policy details in the consent form (Peru, Costa Rica, Argentina). The policy has to exist before the consent form is final.
    6. No limiting language: Argentina bans specific phrases, and Brazil bars any waiver of rights.

    How to sequence insurance with your submission

    1. Pick the countries first. Local-insurer and term rules differ, and a policy built for one country doesn’t automatically travel.
    2. Get the protocol to near-final. Insurers underwrite a specific study. Some brokers will quote from a solid draft, but they still need the design, risk level, enrollment, sites and duration. See our companion guide, What insurers need before they’ll quote a clinical trial policy.
    3. Request quotes for both a master policy and local policies at the same time. Ask the broker to confirm in writing which countries need admitted local paper.
    4. Draft the consent form injury section with the policy details in hand.
    5. Bind and issue certificates before the ethics submission in countries that require the policy upfront. In Mexico, have it ready to file within 15 business days of COFEPRIS authorization.
    6. Diarize the tail. Costa Rica and Peru set minimum periods after the study ends.

    Related guides

    How bioaccess® helps

    We build insurance into the submission plan from the first country decision. We line up the protocol, consent forms and site list the insurer needs, coordinate certificates and named-insured endorsements with your broker, and check the paperwork against each ethics committee’s checklist. We’re not an insurer, and we don’t sell or bind policies.

    Talk to bioaccess® about your country plan

    FAQ

    Is clinical trial insurance legally required in Latin America?
    In most of the main markets, yes. It’s required by statute or regulation in Peru, Costa Rica, Argentina (drug trials), Chile, Guatemala and Mexico, where a financial fund is the alternative. Colombia, the Dominican Republic and El Salvador list it in ethics or submission requirements. Brazil requires the sponsor to indemnify but doesn’t require a policy in its 2024 law, and CONEP’s guidance says ethics review doesn’t ask for proof of insurance. Panama requires documented financial provisions.

    Can I use my US product liability or global master policy?
    Sometimes, as part of the program, but often not by itself. Argentina requires insurance constituted in Argentina. Peru requires coverage in Peru with a local legal representative for foreign insurers. Costa Rica requires a policy enforceable in Costa Rica from an insurer with a local service presence. Mexico’s insurance law bars foreign insurers from writing liability cover for events in Mexico, and Brazil, Chile, Colombia, Panama and the Dominican Republic have their own limits on cover from insurers that aren’t authorized locally.

    Can I get a quote before I have a protocol?
    Not a meaningful one. Insurers price the specific study: its design, risk, enrollment, countries, sites and duration. In Mexico (per NIH ClinRegs) and at some Chilean ethics committees, the policy must identify the study. A near-final draft is the practical minimum.

    Is there a minimum coverage amount?
    None of the national rules we reviewed sets a dollar minimum. Colombia’s GCP resolution refers to “international standards”, and Guatemala requires payouts equal to what the sponsor would pay for the same damage in the trial’s country of origin. None of the ethics-committee rules we read in Chile, Colombia, Peru, Brazil or Córdoba sets one either. Limits are set by contracts and underwriting.

    How long must the policy last?
    It depends on the country. In Costa Rica, under Decreto 39061-S art. 14, at least two years after the final report is delivered to the CEC, and three years after each participant’s participation ends; Ley 9234 art. 31 sets a floor of two years after participation ends. In Peru, until the National Final Report and longer while late damage is possible. In Chile, CEC Salud UC asks for coverage through formal closure, including the last follow-up; the other Chilean committee rules we read don’t set a term.

    Who must hold the policy, the sponsor or the CRO?
    The sponsor, or the authorization holder in Chile. According to ClinRegs, Peru accepts a policy held by the sponsor or the CRO, but under art. 29 the sponsor’s duty to compensate stays in place. Costa Rica also requires the sponsor to cover the investigator and team, and the PI to hold their own policy.

    Does Mexico still require the policy before approval?
    COFEPRIS no longer requires it in the initial application, since its April 2025 simplification Acuerdo. The policy or fund is filed within 15 business days after protocol authorization, and missing it can lead to revocation. Ethics committees may still ask to see it before they approve.

    Are medical-device trials treated the same as drug trials?
    Mostly, but through different rules. Argentina’s 2025 rule and Colombia’s GCP resolution are written for medicines. Guatemala’s Acuerdo 82-2019 covers device trials too (§§2, 41, 43.8). In Argentina, ANMAT’s device rule has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there, and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved. Colombia’s INVIMA checks for a policy in device studies under Res. 8430/1993. Chile’s statute covers devices, with the classes still to be set by a decree that hasn’t been issued, and DS 114/2010 art. 25 requires every protocol to set out its insurance and guarantees; in the meantime, Chilean ethics committees such as Universidad de Chile’s CEISH and Hospital del Trabajador’s CEC already ask for the policy in device or implant trials. Córdoba’s ethics council requires it for non-registration pilot studies of devices. Costa Rica’s Ley 9234 requires the policy for clinical research, defined as experimental, clinical or interventional biomedical research (arts. 2 and 31), whatever the product, so device trials are included. Peru’s DS 021-2017-SA defines the investigational product as a pharmaceutical product or a medical device (art. 2), so its art. 28 insurance rule applies to device trials too.

    Sources

    Primary texts were read on 28 October 2026 and re-checked, with the insurance laws added, on 29 October 2026. See the inline links above and in the table. Ethics-committee documents (CONEP; Córdoba’s CoEIS; La Sabana and Valle del Lili in Colombia; EsSalud Cusco in Peru; and seven Chilean committees) were read on 29 October 2026 and are linked where cited; they describe committee practice, not law. Secondary, and labelled where used: NIH ClinRegs country profile for Mexico.

    Last verified: 29 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.

  • Precision for Medicine New Zealand vs a Latin America First-in-Human Device CRO (bioaccess®)

    If you typed Precision for Medicine (New Zealand) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Precision publishes (Precision for Medicine: New Zealand Clinical Trial Landscape (21 Nov 2025)) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

    What Precision publishes

    Precision for Medicine says New Zealand runs “about 20-25% of Australia’s” trial load and “can start even faster than Australia, including in First-In Human (FIH) studies”. It cites 4–6 weeks from ethics submission to trial start, no IND, and 30–50% lower costs than the U.S. or Europe. It also lists Medsafe “approval time of 45 days”. Medsafe’s current guideline gives a target of 32 working days for drug trial applications, and device trials don’t need Medsafe approval at all. The article names New Zealand early-phase sites but doesn’t describe Precision’s own device first-in-human studies there.

    Precision vs bioaccess®

    Dimension Precision bioaccess®
    Core focus Global CRO, oncology and precision-medicine led First-in-human and early feasibility studies for medical devices
    Geography Global, including Australia and New Zealand Latin America, since 2010
    Device FIH track record Not covered in the New Zealand article Published case studies on bioaccessla.com
    After the trial See provider site Multi-country sanitary registration and in-country holder service

    Where each one fits

    For biomarker-heavy oncology or early-phase drug programs spanning Australia and New Zealand, Precision’s model makes sense.

    If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Precision, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

    New Zealand offers real country advantages:
    – device trials need HDEC ethics approval but no Medsafe approval;
    – one ethics review covers all sites;
    – HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

    Those advantages belong to the country, not to Precision. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

    Frequently asked questions

    How long does Medsafe take to approve a trial?

    For new medicines, Medsafe’s guideline targets an outcome within 32 working days of receiving the application, once fees are paid. Medical device trials need HDEC ethics approval but no Medsafe approval.

    Does a device trial in New Zealand need Medsafe approval?

    No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

    Can Latin American device data support an FDA submission?

    Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

    When is bioaccess® the better choice than Precision?

    When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts come from the Precision public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

  • Novotech New Zealand vs a Latin America First-in-Human Device CRO (bioaccess®)

    If you typed Novotech (New Zealand) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Novotech publishes (Novotech: Why New Zealand Is Emerging as a Clinical Trial Hub (3 Feb 2025)) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

    What Novotech publishes

    Novotech promotes New Zealand as a “high-quality, cost-efficient hub for early-phase and innovative clinical research”. It says trials “can typically begin within 4–6 weeks of ethics submission”, with “no need for IND approval for most early-phase studies”, and that New Zealand can be “30–50% more cost-effective” than the U.S. and Europe, plus a 15% R&D tax credit. It positions New Zealand as “a pilot study location before expanding globally” and “a back-up country”. The article focuses on oncology, vaccines, CNS and rare diseases, and doesn’t discuss device first-in-human studies.

    Novotech vs bioaccess®

    Dimension Novotech bioaccess®
    Core focus Full-service Asia-Pacific CRO, drug-led First-in-human and early feasibility studies for medical devices
    Geography Asia-Pacific, including New Zealand Latin America, since 2010
    Device FIH track record Not covered in the New Zealand article Published case studies on bioaccessla.com
    After the trial See provider site Multi-country sanitary registration and in-country holder service

    Where each one fits

    For a drug program that will expand across Asia-Pacific, Novotech’s New Zealand-plus-region model is coherent. For Novotech’s Australian positioning, see our Novotech Australia page.

    If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Novotech, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

    New Zealand offers real country advantages:
    – device trials need HDEC ethics approval but no Medsafe approval;
    – one ethics review covers all sites;
    – HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

    Those advantages belong to the country, not to Novotech. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

    Frequently asked questions

    Are the 4–6 week and 30–50% figures official?

    No. They are Novotech’s own claims. The official figures are HDEC’s 15- and 35-day review targets and Medsafe’s 32-working-day target for drug trial applications. Devices don’t need Medsafe approval.

    Does a device trial in New Zealand need Medsafe approval?

    No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

    Can Latin American device data support an FDA submission?

    Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

    When is bioaccess® the better choice than Novotech?

    When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts come from the Novotech public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.