On March 20th of this year, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) published the Guidelines that define the requirements for Certificates of Good Manufacturing Practices (GMP) or equivalent documents, necessary for sanitary registrations, renewals, and modifications.
Update
On March 20, 2025, the Agreement was published, issuing the Guidelines for the submission of documents guaranteeing good manufacturing practices for drugs, medications, and medical devices that accompany applications for new sanitary registrations, their renewals, and modifications. Through the published Guidelines, the aspects that the Certificates of Good Manufacturing Practices (GMP) or equivalent documents that are attached to the applications for new sanitary registrations, renewals, and/or modifications of drugs, medications, and medical devices must comply with are defined.
Regulatory Framework
Within the various sections that comprise these Guidelines, the characteristics that COFEPRIS will take into account to guarantee the validity of the documents presented, whether physically or digitally, are specified. Likewise, the documents that will be considered equivalent to recognize the good manufacturing practices of medical devices when they are carried out abroad are established; the equivalent documents will be the following:
MDSAP Audit Certificate, according to the ISO13485 standard.
Document that certifies compliance with Good Manufacturing Practices, issued by a National Regulatory Agency (NRA).
In addition to the NRAs mentioned in the list published in 2022, ANMAT (Argentina), INVIMA (Colombia), and ISP (Chile) were added.
ISO 13485:2016 Audit Certificate in its current version issued by an ISO accredited Certification Body.
CE mark certificate for medical devices issued by a Body approved by the European Commission, and
Explicit declaration of compliance with good manufacturing practices included within the CLV issued by an NRA or, where appropriate, by the corresponding Ministry that regulates the product.
These same criteria are applicable to establishments that act as contract manufacturers within the national territory hired by a legal manufacturer abroad, not limiting them to necessarily having the certificate of good practices issued by Cofepris.
Finally, the validity of the GMP certificates issued by COFEPRIS is announced, which will be 30 months and may be extended on a single occasion for up to 15 months as long as the requirements specified in the same guidelines are met. With the issuance of these Guidelines, COFEPRIS seeks to continue optimizing its authorization and sanitary surveillance processes, as well as to correspond to PIC/S, T-MEC, and the Pacific Alliance in order to guarantee the safety, quality, and effectiveness of health supplies that are available to the population.
Effects from the RA update
With the issuance of these Guidelines, COFEPRIS seeks to continue optimizing its authorization and sanitary surveillance processes, as well as to correspond to PIC/S, T-MEC, and the Pacific Alliance in order to guarantee the safety, quality, and effectiveness of health supplies that are available to the population.
Written By:
Mariel Antonio
Israel Jiménez
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