Mexico COFEPRIS Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios)
Key Legislation:
- Ley General de Salud (General Health Law)
- NOM-241-SSA1-2025: Good Manufacturing Practices for Medical Devices (replaced NOM-241-SSA1-2021, effective April 2025)
- NOM-137-SSA1-2008: Labeling of Medical Devices
Classification: Risk-based, 3 classes:
- Class I (low risk) | Class II (medium risk) | Class III (high risk)
Registration Pathway:
- Standard route: Full technical dossier submission with GMP certification
- Abbreviated Regulatory Pathway (Equivalency Route): For devices approved by reference authorities (FDA, EU, MDSAP members) -- 30 business day target review
- GMP certification: COFEPRIS BPF certificate, or ISO 13485 / MDSAP certificate accepted as equivalent
Key Requirements:
- Sanitary Registration (Registro Sanitario) required before commercialization
- Local authorized representative required for foreign manufacturers
- NOM-241-SSA1-2025 GMP compliance (MDSAP recognized as equivalent)
- Spanish-language labeling and IFU required (per NOM-137)
- Certificate of Free Sale (CFS) from country of origin
Current Key Guidance:
- NOM-241-SSA1-2025 (DOF Publication)
- COFEPRIS Medical Devices Portal
- Abbreviated Pathway (Via Regulatoria Abreviada, DOF 2025)
Latest Updates
No recent updates available. Please check back later.