The Mexican Secretariat of Health (Spanish: Secretaría de Salud) is the agency in charge of the national health policy and other aspects of health services, including regulating drugs and medical devices. The Ley General de Salud, or General Health Law, is the framework that contains the regulation for importing and exporting medical products and food.
COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) is the department within the agency that deals with the importation of medical devices and issues advertising permits for these products. It was founded in 2001 with the dispositions of the Article 17 Bis of the General Law of Health 1 and Article 4 of the Constitution. COFEPRIS is a decentralized and autonomous body run by a comissioner appointed by the Mexican president and deals with controling health facilities, sanitary control of advertising activities as well as monitoring the manufacturing, import or export of health products.
Some of the most important regulations for medical devices in Mexico are:
- 2010 Equivalency Agreement (English)
- Medical Device Labeling - COFEPRIS NOM 137 (English)
- Criteria for the Classification of Medical Devices (English)
A full list of COFEPRIS regulations can be found here.
Medical Device Associations in Mexico: