August 25, 2025
By Pedro Omar Sánchez Neri and Evangeline Loh
The medical device regulator in Mexico, COFEPRIS, has enacted several pieces of medical device legislation in quick succession. An initial agreement (June 11) introduced Reference Regulatory Authorities (RRA) with limited details. A second agreement (July 18) voided the June agreement and explained the structure and requirements for regulatory reliance on RRA authorizations. COFEPRIS has now simplified medical device registration and cited laws to eliminate bureaucratic procedures (August 22).
Agreement synopsis
The August 22 agreement applies to all health supplies within COFEPRIS’s remit. Five tables are included. The tables associated with Articles 1-3 consolidate procedures, announce the relevant homoclave and list the requirements. Article 5 provides new timelines purported as a reduction in review time from current practices and Article 6 lists cancelled procedures.
According to Article 2, homoclave COFEPRIS-04-070 and COFEPRIS-04-060 apply to the registration of low-risk medical devices and other devices, respectively for both Mexican and foreign manufacturers under the standard route.
Articles 1 and 5 address implementation dates for these simplified homoclaves. COFEPRIS states that reduced review times will only occur if the necessary technology tools, submission platforms procedure resolutions have been implemented and are operational by the implementation date.
Past equivalence agreements eliminated
Effective October 6, COFEPRIS won't accept equivalence registrations from the U.S. Food and Drug Administration (FDA), Health Canada and the Japan MHLW.
RRAs can still be leveraged
RRA regulatory authorizations described in the July 18 agreement can be leveraged. Here’s our blog on the subject. This approach becomes effective September 1.
Watch our regulatory updates for further details
COFEPRIS appears committed to simplifying medical device registrations. The July 18 agreement reinforces COFEPRIS’s intent to focus on true reliance and expedited review. This additional agreement further simplifies procedural complexity for medical device registrations. Emergo experts monitor Mexican medical device legislative developments and will issue updates.
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