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
- 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.
- 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.
- 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.
- Amendments can trigger it again. A change of sponsor (modality J of COFEPRIS-09-012) requires the policy or fund again.
- Local insurer. We haven’t found a COFEPRIS rule requiring a Mexican-admitted insurer. Ask your broker how Mexican insurance law applies to your placement.
Related guides
- Clinical trial liability insurance in Latin America: requirements by country (our hub guide)
- What insurers need before they’ll quote a clinical trial policy
- Costa Rica: Ley 9234 insurance requirements
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.
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: 28 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.