General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.
What the law says (verified 29 October 2026)
Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. The rule for this country, from the primary text:
- Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.
If you searched Mexico COFEPRIS clinical trial coverage, buy trial insurance Mexico device FIH, COFEPRIS liability policy, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.
Mexico is a real FIH geography for devices. COFEPRIS reviews the protocol after ethics clearance, on a calendar we confirm per protocol. Neither review is a premium. Coverage still has to be documented: ethics committees review it, and since April 2025 COFEPRIS receives the policy or financial fund within 15 business days after it authorizes the protocol. bioaccess® is not the Mexican carrier.
This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: COFEPRIS / Mexican ethics coverage exhibit. Same operator: the CRO runs the trial; a carrier writes the paper.
The CRO is not the carrier
Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:
- Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
- Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
- CRO. Protocol, IB, ICF, ethics/COFEPRIS packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.
Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.
Do not confuse registro sanitario with trial liability
The Mexico hub keeps trial clocks separate from registro sanitario (~30 working days on that hub). A commercial registro is not a clinical-trial form. A COFEPRIS trial authorization is not a 21 CFR 812.28 clearance. Buying “Mexico coverage” from a product-liability broker who has never seen an investigational IB is how you get a territory endorsement that still fails the committee.
Spanish certificate, named site, named PI
Mexican ethics will read Spanish. They will look for the site and the investigator. They will look for a period that covers follow-up. Guadalajara, Monterrey, Mexico City, Zapopan, and Veracruz campuses on our site pages are sites — they are not insurers. Do not email a hospital asking them to “include insurance” and call it COFEPRIS-ready. The hospital’s institutional policy is not the sponsor’s trial form.
What ethics and COFEPRIS actually ask for
Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.
Since the April 2025 COFEPRIS Acuerdo (art. 5), the insurance or financial fund is filed within 15 business days after protocol authorization rather than with the initial application; missing it can lead to revocation. Typical asks (confirm with the reviewing body):
- Territory that names every country on the protocol.
- Site and principal investigator as additional insureds when the committee requires it.
- Policy period through last-patient last-visit plus the protocol follow-up window.
- Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
- Claims-notice language that can sit next to the SAE clock, not against it.
None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. Ask the carrier and the CRO together, before the packet goes in.
Local policy vs controlled master
A master that names “Mexico” in a 100-country schedule can still fail if it cannot issue a Spanish certificate for this protocol. A local Mexican policy can still fail if the protocol later adds Colombia. Ask which object you are buying. bioaccess® can introduce a specialty carrier. We do not bind COFEPRIS risk.
A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.
What bioaccess® still owns after you have a quote
- Regulatory-fit, not tourism. Mexico is not a substitute for Colombia or Panama. We pick the country the device needs. bioaccess® still runs trials in Colombia. A Mexican certificate does not replace an INVIMA exhibit.
- Protocol, IB, ICF, and the ethics / COFEPRIS packet with insurance documents in the same stack — not a parallel founder email.
- Importer of record and device accountability. A binder does not import the investigational product.
- Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
- Introducing a specialty carrier when the founder does not already have admitted paper. An introduction is not a partnership or a quote.
The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.
Frequently asked questions
Does bioaccess® sell clinical trial insurance?
No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind.
Is this the same article as the LATAM insurance hub?
No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page is COFEPRIS / Mexican ethics coverage exhibit.
Can a U.S. product-liability policy cover a LATAM device FIH?
Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.
Next step
If the search that brought you here was Mexico COFEPRIS clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico operator pages: Clinical Trials in Mexico and CRO in Mexico. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.
Julio G. Martinez-Clark, CEO · bioaccess®