IMDRF — Mexico's Membership & Alignment
COFEPRIS is a member of the International Medical Device Regulators Forum (IMDRF), the principal international body that brings together medical device regulatory authorities to harmonise regulatory approaches globally.
What IMDRF membership means for Mexico
IMDRF membership has directly driven Mexico's regulatory modernisation:
- The Equivalency Route (Sept 2025) explicitly recognises approvals from all IMDRF member authorities — making IMDRF membership the primary basis for Mexico's fast-track pathway.
- COFEPRIS alignment with IMDRF SaMD guidance is shaping Mexico's evolving digital health framework.
- Mexico participates in IMDRF working groups on SaMD, UDI, auditing, and clinical evidence — influencing future NOM updates.
IMDRF members recognised for the Equivalency Route
All full IMDRF member regulatory authorities are recognised by COFEPRIS for the Equivalency Route (per the June 2025 Acuerdo):
- FDA (USA)
- Health Canada (Canada) — Class II and above
- European Commission / EU MDR (via CE marking)
- TGA (Australia)
- PMDA (Japan)
- Swissmedic (Switzerland)
- MFDS (South Korea)
- HSA (Singapore)
- ANVISA (Brazil)
- COFEPRIS itself is a member
IMDRF guidance documents relevant to Mexico
| IMDRF document | Relevance |
|---|---|
| SaMD N10, N12, N23, N41 | SaMD classification, clinical evaluation, lifecycle |
| UDI guidance | COFEPRIS alignment with unique device identification |
| Clinical evidence | Framework for assessing clinical data across markets |
| Adverse event terminology | Harmonised definitions used in technovigilance |
| MDSAP audit programme | QMS audit recognition |