The Federal Executive through the Ministry of Health establishes the requirements that must be met during the manufacturing process of medical devices that guarantee the quality and functionality of the devices, in order to monitor and safeguard one of the most important points for the population, which is the health of the community.

The implementation of Good Manufacturing Practices (GMP) is a fundamental part of a quality management system, which is a strategic decision of the organization; the design and implementation of the system is influenced by the manufactured product, process, size and structure of the company or organization that decides to carry it out.

The Ministry of Health will exercise sanitary control in manufacturing establishments, conditioning warehouses and distribution of medical devices following the criteria established in the Mexican Official Standard NOM-241-SSA1-2012.

All the requirements of the standard range from the classification of medical devices, organization of an establishment, personnel, documentation, design and construction of an establishment dedicated to the production, to the conditioning, storage and distribution of medical devices.

Likewise, manufacturing control, manufacturing equipment, handling of product out of specifications, returns and complaints, product withdrawal from the market, validation, stability studies, change control, deviations, technical audits, destruction and final destination of contaminating and/or hazardous waste, concordance with international and Mexican standards, conformity assessment and even its validity.

Also based on the changes, needs and vanguard of the world market, the Mexican official standards require changes, so we have been conducting talks, meetings, proposals and projects for these changes.