Mexico: Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices

 

Mexico has published an interpretative guidance for the Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices.

Interpretation Criteria for the Mexican Official Standard NOM-241-SSA1-2025: Good Manufacturing Practices for Medical Devices

For the purposes of Section 5 and any sections related to Quality Management System (QMS) requirements in NOM-241-SSA1-2025, which are aligned with ISO 13485 and addressed in the MDSAP processes, as well as with Section Two (Medical Devices) of Chapter Four of the Agreement issuing the Guidelines for the submission of documents guaranteeing Good Manufacturing Practices (GMP) for drugs, medicines, and medical devices accompanying applications for new sanitary registrations, extensions, and modifications, and in accordance with Article 3, Sections II, IV, XV, and 24 of the Agreement establishing the General Guidelines for the abbreviated regulatory pathway for sanitary registrations recognizing tests and evaluation procedures of reference regulatory authorities and the WHO prequalification program as equivalent, the Government of Mexico, through COFEPRIS, recognizes the following:

First. Compliance with the Medical Device Single Audit Program (MDSAP) is deemed equivalent to fulfilling the QMS requirements of NOM-241-SSA1-2025, including audits, verifications, and certification reports issued under MDSAP. Consequently, there is no need to undergo additional regulatory or conformity assessment procedures related to QMS, including inspections or audits, for any manufacturing site, regardless of its location or the commercial destination of the products manufactured.

Second. For applications for sanitary registration, extensions, or applicable modifications of medical devices, applicants—regardless of whether the manufacturing site is located in Mexico or abroad—may submit either a Certificate of Good Manufacturing Practices (CGP) in accordance with Article 11, or an equivalent document in line with Sections I–V of Article 15 of the Guidelines for the Submission of Documents Guaranteeing GMP, as referenced above.

To find out more about compliance for medical devices, do not hesitate to contact the Product Compliance Institute.