Mexico - Draft Mexican Official Standard PROY-NOM-241-SSA1-2024: Good Manufacturing Practices for Medical Devices

​This agreement establishes guidelines for submitting Good Manufacturing Practice (GMP) certificates or equivalent documents for drugs, medicines, and medical devices as part of applications for new health registrations, extensions, or modifications.

Additionally, it outlines general provisions for an abbreviated regulatory procedure that recognizes requirements, tests, and evaluations from reference regulatory authorities and the WHO Prequalification of Medicines Program. 

This aims to streamline the granting of health registrations for health products by the Federal Commission for Protection against Health Risks in the national territory.