Mexico clinical trial regulatory guide

Regulator: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)

Mexico is rapidly emerging as a clinical trial powerhouse in Latin America. COFEPRIS has undergone significant digital modernization through its DIGIPRIS platform, offering an abbreviated pathway (Vía Abreviada) for certain study types. Mexico's large, diverse population and proximity to the US make it an increasingly attractive destination for FIH and pivotal studies.

Approval process

1. Ethics Committee Review. Submit to a CONBIOÉTICA-registered ethics committee. Mexico requires both a Research Ethics Committee (CEI) and a Research Committee approval.
2. COFEPRIS Application. Submit clinical trial authorization via DIGIPRIS digital platform. Includes protocol, IB, device dossier, ethics approval, and investigator credentials.
3. Import Permit. Obtain COFEPRIS import authorization for investigational devices.
4. Site Activation. Complete site agreements, investigator training, and regulatory binder setup.

Ethics requirements

• Ethics committee must be registered with CONBIOÉTICA
• Dual committee review: CEI (ethics) + CI (research committee)
• Informed consent in Spanish per NOM-012-SSA3-2012
• Participant insurance/indemnity required
• Annual continuing review

Documentation requirements

• Clinical trial protocol in Spanish
• Investigator brochure
• Device technical dossier
• GMP/ISO 13485 certificates
• Insurance certificate for participants
• Investigator CV and GCP training certificates

Device registration

Mexico follows a risk-based classification (Classes I, II, III). COFEPRIS registration requires a local legal representative, technical documentation, and typically varies by study (we confirm it per protocol). The Vía Abreviada pathway can expedite approvals for devices with prior FDA or CE approval.

FDA acceptance of Mexico data

FDA accepts Mexican clinical data under 21 CFR 812.28. Mexico's proximity to the US, large diverse patient population, and COFEPRIS's alignment with international standards make Mexican data particularly well-regarded by the FDA for IDE and 510(k) submissions.

Key contacts

• COFEPRIS — Federal Commission for Health Risk Protection
• CONBIOÉTICA — National Bioethics Commission

Frequently asked questions

What is COFEPRIS's Vía Abreviada?

An abbreviated COFEPRIS review pathway for certain clinical trials with prior approvals from reference regulators. The timeline varies by study; we confirm it per protocol.

How has DIGIPRIS changed the process?

DIGIPRIS is COFEPRIS's digital platform that has streamlined submissions, reduced paperwork, and improved transparency.

Can I use Mexican data for FDA submissions?

Yes. FDA readily accepts Mexican clinical data when studies follow ICH-GCP and ISO 14155 standards.

What's unique about Mexico's ethics review?

Mexico requires dual committee review — a Research Ethics Committee (CEI) and a separate Research Committee (CI).

Is Mexico suitable for FIH studies?

Increasingly yes, especially with the Vía Abreviada pathway. Mexico is positioning itself as a regional clinical trial hub.

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