Mexico's COFEPRIS Revolutionizes the Medical Device Industry with New Manufacturing Standards

COFEPRIS Updates NOM-241-SSA1-2025: A Strategic Shift Toward Global Alignment in Medical Device Manufacturing

COFEPRIS has announced key modifications to the Mexican Official Standard NOM-241-SSA1-2025, which governs Good Manufacturing Practices (GMP) for medical devices. These changes mark a significant step toward harmonizing national regulations with international standards, enhancing clarity, and ensuring greater operational efficiency across the industry.

One of the most impactful updates is the removal of the section on medical device classification, reflecting a more focused approach by eliminating elements not essential to GMP compliance. In a forward-looking move, dedicated manufacturing lines for Software as a Medical Device (SaMD) have also been introduced—addressing a rapidly growing segment in the industry.

To support industry adoption, a comprehensive Q&A guide has been released to help stakeholders interpret and apply the updated standard more effectively.

The revised NOM-241-SSA1-2025 outlines minimum requirements for design, development, manufacturing, storage, and distribution processes—now aligned with the technical documentation standards of the International Medical Device Regulators Forum (IMDRF). This alignment not only fosters regulatory convergence but also boosts global competitiveness for manufacturers operating in or exporting from Mexico.

Notable amendments include:

• Deletion of Section 5, which previously covered device classification.

• Clarification of Annual Product Review (APR) requirements under Section 5.6.6.5.

• Addition of Section 11.4, specifying detailed requirements for retention samples.

These updates are critical for regulatory teams, manufacturers, and quality assurance professionals to understand and implement promptly.

If you have questions about how these changes might affect your compliance strategy or need guidance in adapting your processes, our team is here to help.

**WHO DOES THIS AFFECT? **

Therefore, the direct impact is on medical device manufacturers, consumers, and patients.

**CONCLUSION: **

These modifications reflect COFEPRIS's commitment to public health in Mexico, ensuring that medical devices are safe and effective for use by end consumers.

Regulatory Impact:

Top Priority: Yes Type of Certificate: No Spectrum Bands: No Import Changes HS Codes: No Standard Changes: Yes Product Changes: Yes Label Changes: Yes