NOM-241-SSA1-2025 — Good Manufacturing Practices
NOM-241-SSA1-2025 (Buenas Prácticas de Fabricación para Establecimientos Dedicados a la Fabricación de Dispositivos Médicos) is Mexico's mandatory GMP standard for medical devices.
Publication and entry into force
- Published: in the Diario Oficial de la Federación (DOF) in 2025.
- In force: April 2025.
- Replaces: NOM-241-SSA1-2021.
Issuing authority
Issued by the Secretaría de Salud (Ministry of Health) through COFEPRIS, under the authority of the Ley General de Salud and the Ley Federal sobre Metrología y Normalización.
Scope
NOM-241 applies to:
- All manufacturing establishments for medical devices (Class I, II, III) marketed in Mexico.
- Importers — must demonstrate that the foreign manufacturer meets equivalent GMP requirements.
- Storage and distribution facilities — Chapter 19 applies to all warehousing and distribution operations.
- MRHs — responsible for ensuring GMP compliance in their supply chain.
Key changes from NOM-241-SSA1-2021
| Change | Detail |
|---|---|
| Classification chapter removed | Device classification rules now exclusively in the Reglamento and the Mexican Pharmacopoeia |
| Sample retention consolidated | All sample retention requirements in a single chapter |
| Mexican Pharmacopoeia alignment | Classification references updated |
| SaMD acknowledgement | Software as a Medical Device provisions included |
ISO 13485 equivalency
COFEPRIS formally recognises ISO 13485:2016 certification as meeting NOM-241 GMP requirements. Key implications:
- ISO 13485 certificates issued by UKAS, DAkkS, ANAB, or other IAF-recognised accreditation bodies are accepted.
- MDSAP audit certificates are also accepted.
- Manufacturers already ISO 13485 certified do not need a separate Mexican QMS assessment.
Official text access
The full NOM-241-SSA1-2025 text is available through:
- DOF (dof.gob.mx) — search "NOM-241-SSA1-2025".
- COFEPRIS website — regulatory requirements section for medical devices.
An unofficial English translation of the prior NOM-241-SSA1-2021 version is available from the Inter-American Coalition for Medical Technology (IAMTECH) but is not an official document.