Mexico medical device registration timeline
Source-linked clocksComisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) review clocks and end-to-end planning ranges, using the 3-class (I, II, III) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Libre de Venta (LR) or Registration) RIS Art. 179: Clase I resolved within 30 calendar days, with positive administrative silence (deemed approval) on lapse | 30 days | 3 months | — | Verified |
| Class II(Registration or Equivalency) RIS Art. 179: Clase II resolved within 35 calendar days (15 days with a favourable Tercero Autorizado dictamen) | 35 days | 1.3-2.6 years | 8-16 months | Verified |
| Class III(Registration or Equivalency) RIS Art. 179: Clase III resolved within 60 calendar days (15 days with a favourable Tercero Autorizado dictamen) | 60 days | 1.3-2.6 years | 8-16 months | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Mexico Medical Device Registration Process
Step-by-step COFEPRIS registration process. Total estimated timeline: 3 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by COFEPRIS. Appoint a Mexico Registration Holder (MRH).
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to COFEPRIS including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksCOFEPRIS reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
30 daysIn-depth technical assessment of device safety and performance. COFEPRIS may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, COFEPRIS issues Mexico market authorization certificate.
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Eligibility: Prior authorisation by a Reference Regulatory Authority in one of the twelve IMDRF Management Committee jurisdictions: Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom, the United States, MDSAP full members are recognised for the good-manufacturing-practice certificate, Filed under homoclave COFEPRIS-04-050 rather than the ordinary COFEPRIS-04-060 registration, Post-market surveillance or technovigilance evidence from the reference market, translated into Spanish under RIS Art. 153
- Mexico Registration Holder (MRH) - mandatory for foreign manufacturers
- NOM certification (GMP, labeling)
- Spanish labeling and IFU
- Free Sale Certificate
- First prórroga filed 150 natural days before expiry and resolved within a maximum of 120 days (RIS Arts. 190 Bis 6-7); Annex 1 dossier deficiencies cured within 20 working days
MDSAP: Since the July 2025 Lineamientos, MDSAP full members are recognised for the good-manufacturing-practice certificate. It is not a substitute for the registration decision itself, which still goes through COFEPRIS-04-050 or the ordinary route.
Reviewed 2026-08-30. End-to-end totals remain planning estimates.