Pre-Market Overview
Before a medical device can be manufactured, imported, or sold in Mexico, it must hold a sanitary registration (registro sanitario) issued by COFEPRIS — unless the device is explicitly exempt under the 2025 Annex 2 classification decree or falls outside health supply regulation (Annex 3).
What sanitary registration covers
A COFEPRIS sanitary registration:
- Confirms the device has been assessed for safety and performance.
- Authorises the device for the specific intended use described in the application.
- Is tied to the specific model, configuration, and manufacturer reviewed.
- Is held by the Mexico Registration Holder (MRH) — not directly by the foreign manufacturer.
The two registration routes
COFEPRIS offers two pathways to sanitary registration:
| Route | Basis | Target timeline |
|---|---|---|
| Standard Route | Full technical dossier reviewed from scratch | 20–180 business days (varies by class) |
| Equivalency (Abbreviated) Route | Leverages existing IMDRF/MDSAP authority approval | 30 working days |
Key pre-market steps
- Classify your device (Class I · II · III or Annex category).
- Appoint an MRH (foreign manufacturers only).
- Choose your route (standard or equivalency).
- Prepare your dossier (technical documentation, GMP evidence, labelling).
- Submit via DIGIPRiS and pay government fees.
- Respond to COFEPRIS requests for additional information.
- Receive sanitary registration — listed on COFEPRIS website with unique homoclave.
After registration
Registration is the start of your obligations, not the end. Post-market requirements — technovigilance, GMP, labelling compliance, and 5-year renewal — begin immediately. See Post-Market.