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

 

Mexico has published two additional documents with regard to the Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices.

– Agreement issuing Guidelines for the submission of documents guaranteeing good manufacturing practices for pharmaceuticals, medicines, and medical devices accompanying applications for new health registrations, their extensions, and modifications.

– Agreement issuing General Guidelines for the application of the abbreviated regulatory pathway for granting health registrations for health supplies, recognizing the requested requirements, tests, and evaluation procedures issued by leading regulatory authorities and the World Health Organization’s prequalification program as equivalent.

The objective of the first one is to establish the criteria and requirements for compliance with Good Manufacturing Practice Certificates or equivalent documents for drugs, medicines, and medical devices that accompany applications for new health registrations, their extensions, and modifications.

The objective of the second one is to establish the provisions that the Federal Commission for the Protection against Sanitary Risks must observe, to recognize the decisions of other Regulatory Authorities of Reference, and of the WHO Drug Prequalification Program, for the granting of sanitary registration of health supplies in national territory.

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