COFEPRIS Streamlines Medical Device Registration: Key Takeaways from Articles 22 to 25 of the Official Gazette

In June 2025, COFEPRIS introduced significant updates to its medical device registration process for foreign Manufacturers. These changes are reflected in Articles 22 to 25 of the latest regulatory chapter and aim to simplify the pathway for foreign manufacturers seeking market access in Mexico.

Here’s a breakdown of the most impactful changes:

Article 22: New Recognition of International Approvals

COFEPRIS will now recognize medical device approvals and GMP certifications from a broader list of international regulatory bodies. This includes:

• IMDRF Management Committee Member Countries

• MDSAP Participating Authorities (for Good Manufacturing Practices certification)

Implications:

Manufacturers from recognized jurisdictions will benefit from new equivalence routes, potentially reducing redundancy and speeding up market entry. This recognition marks a significant shift toward global regulatory convergence.

Article 23: Expanded Options for Demonstrating GMP Compliance

Applicants now have multiple acceptable documentation routes to prove compliance with Good Manufacturing Practices (GMP). COFEPRIS will accept:

• A GMP certificate issued by a Reference Regulatory Authority (RRA)

• An MDSAP audit certificate

• ISO 13485 certification from an accredited body

• A CE certificate from an EU Notified Body

• A GMP declaration within a Certificate of Free Sale from an RRA

Implications:

This expanded list of acceptable documents introduces flexibility and reduces administrative burden for Manufacturers in compliance with internationally recognized standards.

Article 24: Homologation Codes for Previously Approved Devices

Devices that have already received approval from select international agencies can now be submitted under new homologation codes, categorized by both device class and country of origin:

• FDA (USA)
  
  • Class I: COFEPRIS-04-001-D
  • Class II & III: COFEPRIS-04-001-E

• Health Canada
  
  • Class II, III, IV: COFEPRIS-04-001-F

• PMDA (Japan)
  
  • Class II (conforming): COFEPRIS-04-001-G
  • Class II (non-conforming), III, IV: COFEPRIS-04-001-H

It has been mentioned that Other Reference Regulatory Authorities (RRAs), as listed in Article 22, may temporarily use these codes until new homologation codes are issued by COFEPRIS.  

Article 25: Accelerated Review Timelines

COFEPRIS now commits to a maximum decision time of 30 business days for medical device registration applications.

Implications:

This potential expedited timeline is a critical advantage for foreign Manufacturers and local distributors looking to launch medical devices swiftly in the Mexican market. If enforced consistently, this could significantly improve time-to-market and reduce regulatory uncertainty.

Final Thoughts

The recent regulatory updates from COFEPRIS represent a positive and pragmatic move toward global regulatory harmonization. By recognizing trusted foreign approvals and certifications, and by committing to faster review timelines, Mexico may become a more attractive destination for medical device innovation and commercialization.

For Manufacturers operating globally, these changes may potentially reduce duplication of efforts, lower additional costs, and shorten the path to access Mexico.

Need help navigating COFEPRIS device registration?

Pure Global offers in-country Mexico Registration Holder (MRH) services and end-to-end support for medical device registration with COFEPRIS. Our regulatory specialists are well-versed in COFEPRIS requirements. We provide tailored guidance to ensure your submissions are accurate, compliant, and positioned for success. Whether you're registering a device already approved by a Reference Regulatory Authority or seeking to leverage ISO certifications, our team is here to support you every step of the way.

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