NOM-241 Overview — GMP for Medical Devices
NOM-241-SSA1-2025 is Mexico's mandatory Good Manufacturing Practices (GMP) standard for medical devices. It entered into force in April 2025, replacing NOM-241-SSA1-2021.
All manufacturers, importers, and relevant supply chain parties for medical devices marketed in Mexico must comply with NOM-241.
Scope
NOM-241 applies to:
- Manufacturers of medical devices (Class I, II, and III) intended for the Mexican market.
- Importers and MRHs — responsible for ensuring the foreign manufacturer meets equivalent GMP standards.
- Distributors and storage facilities — specifically Chapter 19 on warehouse and distribution requirements.
Key changes in the 2025 update
NOM-241-SSA1-2025 introduced several significant changes from the 2021 version:
- Removal of the classification chapter — device classification rules are now solely in the Reglamento de Insumos and the Mexican Pharmacopoeia.
- Consolidated sample retention requirements — all sample retention rules in one section.
- Alignment with the Mexican Pharmacopoeia for classification references.
- SaMD provisions — acknowledgement of software as a medical device category.
NOM-241 vs ISO 13485
COFEPRIS formally recognises ISO 13485 certification as equivalent to NOM-241 GMP compliance for foreign manufacturers. This means:
- An ISO 13485 certificate from an accredited certification body satisfies the GMP evidence requirement in registration applications.
- Manufacturers do not need to build a separate Mexican-specific quality system if they are already ISO 13485 certified.
- ISO 13485 also satisfies NOM-241 through an established equivalency pathway recognised by COFEPRIS.
Similarly, MDSAP audit certificates are recognised as GMP evidence.
Structure of NOM-241
| Chapter | Subject |
|---|---|
| Management responsibility | Management system, quality policy, management review |
| Design controls | Design and development process, verification and validation |
| Document and record controls | Document management, traceability records |
| Purchasing controls | Supplier qualification and monitoring |
| Production and process controls | Manufacturing controls, in-process monitoring |
| CAPA | Corrective and preventive action system |
| Complaint handling | Customer complaint process and technovigilance interface |
| Chapter 19 | Storage, warehousing, and distribution |