Post-Market Overview
Obtaining a COFEPRIS sanitary registration is the beginning of your regulatory obligations in Mexico, not the end. Once your device is on the Mexican market, an ongoing framework of requirements applies throughout the registration lifecycle.
Core post-market obligations
| Obligation | Governing standard | Who is responsible |
|---|---|---|
| Technovigilance system | NOM-240-SSA1-2012 | MRH (primary), distributors, facilities |
| Adverse event reporting | NOM-240-SSA1-2012 | MRH → CNFV |
| FSCAs and recalls | NOM-240 / COFEPRIS guidance | MRH + manufacturer |
| GMP compliance | NOM-241-SSA1-2025 | Manufacturer |
| Labelling compliance | NOM-137-SSA1-2008 | MRH / manufacturer |
| Registration renewal | Reglamento de Insumos | MRH |
| Distribution records | NOM-241-SSA1-2025 | MRH + distributors |
Technovigilance — Mexico's PMS system
Technovigilance (tecnovigilancia) is Mexico's post-market surveillance system for medical devices. It is mandatory for all registration holders and is overseen by CNFV (Centro Nacional de Farmacovigilancia), a division within COFEPRIS.
A well-functioning technovigilance system is not just a compliance requirement — it is essential for maintaining your sanitary registration at renewal.
See Technovigilance overview for full detail.
Registration renewal
Sanitary registrations are valid for 5 years. Renewal must be applied for through DIGIPRiS before expiry, with a comprehensive technovigilance report covering the prior 5-year period. From January 2026, subsequent renewals may be granted for up to 10 years.