Mexican Regulator COFEPRIS Revises Equivalency Route to Expand Leveraging Options

By Ana Karen Hidalgo Rodríguez

For the evaluation of health supply registrations, Mexico’s Federal Commission for Protection of Sanitary Risks (COFEPRIS) released a new agreement for the equivalency requirements established in articles 167, 170, 177, 177 Bis 2, 179 and 180 of the Health Supplies Regulations and the technical evaluation procedures performed by COFEPRIS. In these cases, the COFEPRIS review is abbreviated.

Equivalency agreement general provisions

This agreement determines the conditions that COFEPRIS must observe to recognize the decisions of other reference regulatory authorities (RRA) and the World Health Organization's Drug Prequalification Program regarding health supplies, including medical devices.

COFEPRIS’s regulatory decisions will be based on risk management, as well as on the decisions and evaluations made by the RRA (and the WHO Medicines Prequalification Program) to confirm the quality, safety and efficacy of medical devices.

General equivalency provisions for medical devices

The basic essential characteristics of the medical device must be identical to the medical device authorized by the RRA, so the devices that will be commercialized in Mexico are identical to the ones authorized by the RRA. It is important to mention that extraordinary approvals by said RRAs (i.e. reliance obtained approval, emergency authorization et al.) cannot be used to support an application for this type of authorization.

Applications made under this agreement will be evaluated through an abbreviated regulatory process and Article 25 states that this will be resolved within 30 business days. However, in practice, COFEPRIS often takes months to review.

Specific criteria for medical devices

For medical devices, COFEPRIS will accept RRAs such as those listed below:

I. Member countries of the International Medical Device Regulators Forum (IMDRF) Management Committee, and

II. Regulatory Authorities that are members of the MDSAP for Good Manufacturing Practices (GMP) Certifications.

The agreement lists equivalent GMP certificate documents as those issued by the Health Authority of the country of origin, GMP certificate issued by any authority of the ones listed as RRAs, MDSAP, which stands for Medical Device Single Audit Program, certificate, Certificate of Conformity Assessment (CE), or GMP statement from the regulator under the Free Sales Certificate (FSC) for medical devices, a document that confirms a medical device is legally available for sale in a specific country or region.

The COFEPRIS submission codes for the equivalency routes under the U.S. Food and Drug Administration (FDA), Health Canada (HC) and Pharmaceuticals and Medical Devices Agency (PMDA Japan), remain unchanged. Applications under other RRA  must be submitted through any of the existing COFEPRIS submission codes until COFEPRIS announces the new corresponding procedure(s).

Prior equivalency agreements (FDA, HC, PMDA) have been accompanied by specific checklists, COFEPRIS submission codes and guidelines to support and provide context to the application route.

Concluding remarks

This new agreement enables new possibilities for submissions subject to faster review timelines, however, additional information about the required documentation is needed.

We at Emergo by UL will continue to monitor and communicate updates over new COFEPRIS submission codes, requirements and/or guidelines for equivalency applications under other RRA . This is a welcome addition as this further expands regulatory reliance.