Cofepris NOM-241-SSA1-2025 Explained: Key Updates for Medical Device Manufacturers

Mexico has taken another meaningful step toward aligning its medical device regulations with global good manufacturing practice (GMP) frameworks. On November 11, 2025, Cofepris published the Interpretation Criteria for Mexican Official Standard NOM-241-SSA1-2025, the country’s updated GMP standard for medical devices. 

Effective the following day, these criteria clarify how manufacturers should interpret the quality management system (QMS) and GMP requirements under the new NOM-241-SSA1-2025 and how those requirements intersect with ISO 13485, the Medical Device Single Audit Program (MDSAP), and other internationally recognized frameworks.

For manufacturers preparing for the November 30, 2025 enforcement date, the criteria reduce uncertainty and formalize Mexico’s increasing reliance on global regulatory mechanisms. In practical terms, the document confirms that many companies already meet NOM-241 expectations through existing certifications and GMP documents.

A Clearer Pathway Through NOM-241

NOM-241-SSA1-2025 replaces the 2012 version of Mexico’s GMP standard and introduces a more modernized, risk-based approach that aligns closely with international norms. Yet the enhanced complexity of the revised standard raised questions for industry about how Cofepris would interpret core QMS requirements and how much overlap existed with ISO 13485 and MDSAP.

The interpretation criteria answer those questions directly. Cofepris confirms that the Mexican government considers the relevant clauses of ISO 13485, the audit processes used under MDSAP, and GMP expectations from reference regulatory authorities to be equivalent to the requirements of NOM-241-SSA1-2025.

This equivalence carries several important implications:

• It applies to any manufacturing site, whether in Mexico or abroad.
• It applies regardless of the device’s commercial destination.
• It allows manufacturers with ISO 13485 or MDSAP certification to treat those credentials as full evidence of compliance with NOM-241 QMS requirements.

For companies participating in MDSAP, now widely adopted by multinational manufacturers, this equivalence removes the need for a separate Cofepris GMP inspection and creates a more predictable regulatory pathway.

Acceptance of International GMP Documentation

Beyond QMS equivalence, the criteria clarify how Cofepris will treat GMP documentation during registration, renewal, and modification processes. Manufacturers may still submit a Mexican CBPF (Certificado de Buenas Prácticas de Fabricación), but the criteria broaden the range of acceptable documentation.

Cofepris will recognize GMP evidence issued under:

• WHO Prequalification Program
• Reference regulatory authorities
• MDSAP-recognized audit organizations

This clarification gives global manufacturers flexibility to leverage existing GMP certificates and audit reports rather than duplicating documentation specifically for Mexico. For organizations selling into markets such as Canada, the United States, Japan, or Brazil, this is particularly advantageous because many already maintain MDSAP or ISO 13485 documentation that now fulfills NOM-241 expectations.

For regulatory affairs teams, this shift enables a more efficient submission strategy. Global templates can be reused, evidence packages can be streamlined, and GMP pathways can be aligned across jurisdictions. 

These advantages become increasingly valuable for manufacturers managing large product portfolios or facing time-sensitive renewals.

Strengthening Mexico’s Reliance Framework

Cofepris’ interpretation criteria reinforce Mexico’s ongoing commitment to reliance practices, which have become central to the regulatory modernization agenda across Latin America. The document explicitly links NOM-241 to international reliance mechanisms, including the WHO Prequalification Program, MDSAP evaluation practices, and the expectations laid out under the T-MEC and Pacific Alliance agreements.

This shift is not merely procedural. It represents a strategic regulatory direction: Mexico is embracing reliance as a tool to reduce duplication, accelerate access to safe medical technologies, and align with global standards. 

For manufacturers, reliance-based approaches reduce administrative workload and offer greater predictability in both pre-market and post-market phases. Cofepris’ recognition of GMP evidence from trusted authorities also strengthens regulatory maturity by allowing the agency to allocate inspection resources more strategically. 

Instead of repeating audits already conducted under rigorous international systems, Cofepris can focus oversight on higher-risk products or facilities without established certifications.

Strategic Considerations for Global and Domestic Manufacturers

The publication of the interpretation criteria introduces several strategic considerations for organizations preparing for NOM-241 enforcement.

For global manufacturers, the biggest benefit is the ability to rely on existing QMS certifications. Companies with ISO 13485-compliant systems or valid MDSAP certification already satisfy much of NOM-241, and the criteria confirm that their documentation can serve as complete proof of compliance.

As a result, regulatory affairs teams should begin mapping NOM-241 clauses to their existing QMS evidence and ensuring that traceability is well documented. This mapping process will help streamline submissions, reduce the likelihood of follow-up questions from Cofepris, and minimize the need for Mexico-specific documentation.

The criteria also create a strategic inflection point for Mexican manufacturers, many of whom have operated under domestic GMP expectations without fully adopting ISO 13485 or MDSAP. With NOM-241-SSA1-2025 now harmonized with these international frameworks, domestic companies may find it increasingly necessary, and beneficial, to adopt ISO 13485 or pursue MDSAP. 

Doing so would not only streamline compliance in Mexico but also expand export opportunities and reduce future inspection frequency.

For both domestic and global manufacturers, GMP documentation should be reviewed now, including:

• ISO 13485 certificates
• MDSAP reports or certificates
• GMP documentation from reference NRAs
• WHO Prequalification GMP evidence

Ensuring that these documents are valid, up-to-date, and properly formatted will help prevent delays once NOM-241 becomes enforceable. Finally, organizations should revisit their internal submission templates and regulatory strategies for Mexico. 

Adding reliance-based pathways into standard operating procedures can significantly improve efficiency. RA and QA teams should be trained on the interpretation criteria to ensure consistent application across upcoming filings.

Preparing for the NOM-241 Enforcement Date

Although the interpretation criteria are already in effect, the formal enforcement of NOM-241-SSA1-2025 begins on November 30, 2025. This transition period provides manufacturers time to update internal procedures, confirm certifications, and align documentation with Mexico’s new expectations.

The criteria provide the essential framework needed for this transition. Manufacturers now have clear guidance on what Cofepris will accept and how global certification systems correspond to NOM-241 requirements. 

With this clarity, organizations can build more reliable regulatory plans, anticipate documentation needs in advance, and ensure their QMS evidence aligns with Mexico’s updated expectations.

Conclusion

Cofepris’ publication of the interpretation criteria for NOM-241-SSA1-2025 marks a significant step in Mexico’s regulatory evolution. By recognizing ISO 13485, MDSAP, WHO documentation, and evidence from reference regulatory authorities as equivalent to NOM-241 QMS requirements, the agency is reducing duplication, strengthening reliance practices, and creating a more efficient compliance pathway.

For manufacturers, the criteria bring clarity, predictability, and new opportunities to streamline submissions. As the enforcement date approaches, RA and QA teams should leverage this guidance to align internal processes, validate documentation, and ensure readiness for Mexico’s updated GMP framework.