New COFEPRIS Guidelines for Good Manufacturing Practices

In an effort to streamline processes and strengthen the certification of medical devices in Mexico, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) has officially recognized new guidelines related to Good Manufacturing Practices (GMP) for medical devices. While these guidelines were already informally accepted in practice, this new official recognition provides clarity and sets a formal standard for medical device manufacturers. 

Key Guidelines for GMP Compliance

Under the new guidelines, COFEPRIS will accept several equivalent documents to demonstrate compliance with GMP for medical devices. These include the following: 

• • MDSAP Audit Certificate – Compliance with the ISO 13485 standard, as verified through the Medical Device Single Audit Program (MDSAP), will be recognized by COFEPRIS. 
  • Document Certifying Compliance with GMP Issued by a National Regulatory Authority (NRA) – Manufacturers can submit a certification from any recognized National Regulatory Authority (NRA) that verifies GMP compliance. 
  • ISO 13485:2016 Audit Certificate – A valid audit certificate in accordance with ISO 13485:2016, issued by an ISO-accredited Certification Body, will be accepted. 
  • CE Mark Certificate – For medical devices issued by an agency approved by the European Commission, a CE Mark certificate will meet COFEPRIS’s GMP requirements. 
  • Explicit Declaration of Compliance – A formal declaration of GMP compliance included in the Certificate of Free Sale (CLV) issued by an NRA or relevant Ministry will be recognized, even for maquiladora manufacturers based in Mexico that are subcontracted by a legally-owned manufacturer abroad. 

Why This Matters

These new guidelines are part of COFEPRIS’s broader effort to make medical device certification processes more efficient while maintaining the integrity of product safety standards. The recognition of internationally recognized certifications such as ISO 13485 and CE Marking helps streamline approval processes for manufacturers, reducing redundancies and delays. 

What This Means for Manufacturers

Manufacturers seeking approval for medical devices in Mexico will benefit from these clarified and formalized standards. By utilizing the recognized certificates and documentation outlined in the new COFEPRIS guidelines, manufacturers can ensure faster market access, all while meeting the regulatory requirements for GMP compliance. 

The changes to COFEPRIS’s guidelines offer a clearer path forward for manufacturers, as it integrates internationally recognized standards and certifications. However, it is crucial that companies remain up to date with the official recognition of these practices to avoid any compliance issues moving forward. 

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For help navigating COFEPRIS guidelines for Good Manufacturing Practices compliance, contact us today.

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