COFEPRIS Enhances International Product Recognition

The Mexican authority, COFEPRIS, has expanded its international recognition by now accepting regulatory decisions from trusted global authorities (e.g., FDA, EMA, and WHO Prequalification Program) as equivalent to Mexican standards for health product registration. In other words, products already approved by Reference Regulatory Authorities (RRAs) may qualify for a faster, simplified registration process in Mexico—30 business days for medical devices.

While international decisions are considered, COFEPRIS, as the authority, retains exclusive power over final registration approvals.

Regarding the requirements, the complete legal and technical documentation must be submitted, including proof of equivalence with the RRA-approved product.

Once registration is granted in Mexico, any post-approval changes made by the RRA must be reported to COFEPRIS to maintain product equivalence throughout its lifecycle.

Regarding benefits, this is particularly advantageous for small and mid-sized manufacturers seeking to enter the Mexican market. Global manufacturers can also integrate Mexico into their regional launch strategies.

As for fees, there is no change, since the official fees are published every January and remain valid throughout the calendar year.

The agreement applies to both medicines and medical devices. Specifically for medical device manufacturers: 

• COFEPRIS will recognize regulatory decisions for medical devices from: 

• Members of the IMDRF Management Committee (e.g., FDA, PMDA, Health Canada). 

• Authorities participating in the MDSAP program for Good Manufacturing Practices (GMP) certification. 

Due to this, Manufacturers can submit any of the following as valid proof of GMP compliance: 

• GMP certificate from a recognized regulatory authority (per Article 22). 

• MDSAP audit certificate. 

• ISO 13485 certificate from an accredited certifying body. 

• CE Certificate from a Notified Body approved by the European Commission. 

• Declaration of GMP compliance in a Certificate of Free Sale from a recognized authority. 

For more details, on COFEPRIS’s new international recognition for health product registration, read the full article here. 

If you have any questions regarding the above, we encourage you to reach out to our regulatory experts here.