Mexican Regulators Update GMP COFEPRIS Requirements from NOM-241-SSA1-2021 and MDSAP

By Nélyda González

Medical device regulators in Mexico have updated Good Manufacturing Practices (GMP) COFEPRIS requirements from NOM-241-SSA-2021 and the Medical Device Single Audit Program (MDSAP). Since we alluded to the Mexico NOM-241 and Equivalence with ISO 13485 for Medical Devices? in our last regulatory update, COFEPRIS released a new communication (July 6, 2023) related to Mexican Official Standard NOM-241-SSA1-2021, Good Manufacturing Practices for Medical Devices (hereafter NOM-241) and its equivalence with ISO 13485 and MDSAP.

Background on NOM-241

NOM-241 establishes the minimum requirements for design, development, manufacturing, storage and distribution activities to ensure quality, safety and functionality for medical device manufacturers and supply chain stakeholders located in Mexico.

The most recent version of NOM-241 took effect  June 20, 2023.

COFEPRIS communication (July 6, 2023)

This latest communication refers to the agreements from T-MEC's chapter on Technical Trade Barriers (specifically on medical devices) and the Ministry of Health’s commitments as members of the Pacific Alliance to reduce regulatory barriers by harmonization with IMDRF. For those unaware, T-MEC is the trade agreement between Mexico, the US and Canada, which replaced NAFTA.

Based on Article 287 from the General Health Law and further communications from April 28 of this year confirming that manufacturers do not need to comply with NOM-241’s GMP requirements if they are not located in Mexico, or are not selling their products in Mexico, COFEPRIS states:

• The Health Authorization Commission will recognize MDSAP certification as equivalent to COFEPRIS-issued GMP certification for new sanitary registrations, modification and renewal applications for medical devices manufactured in Mexico.
• MDSAP certification will also be considered valid to support sanitary registrations, modifications and renewals of medical devices manufactured abroad.

While COFEPRIS had always accepted MDSAP and ISO certificates from foreign manufacturers, this now establishes it as official policy.

Through this, COFEPRIS advances its commitments with international trade agreements, acknowledging resolutions from other regulatory entities.

There is optimism in the announcement

This communication ends on a promise: COFEPRIS will inform the official criteria for recognition of the accreditation of ISO 13485:2016 as equivalent to the GMP issued by COFEPRIS through NOM-241 in the upcoming days.

More news to come

We expect this news in the future and will share information when it becomes available. Ultimately, this will be a tremendous benefit to manufacturers based in Mexico who will be able to use compliance with MDSAP ISO 13485 to satisfy the requirements of NOM-241.