Mexico Medical Device Regulations

All documents listed below were published by Mexico's COFEPRIS or Secretaria de Salud and are in PDF format.

Major Regulations
Document Number Published Language
Download Ley General de Salud - General Health Law MX-011 12/2018 Spanish
Download Reglamento de Insumos para la Salud - Regulation of Health Supplies MX-010 09/2012 Spanish
Specific Guidance Documents
Document Number Published Language
Download Good Manufacturing Practices NOM 241 SS A1-2012 11/2012 English
Download Installation and Preparation of Technovigilance NOM 240 SS A1-2012 10/2012 English
Download Medical Device Labeling NOM 137 SS A1-2008 10/2008 English
Download Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos NOM 241 SS A1-2012 11/2012 Spanish
Download Instalación y operación de la tecnovigilancia NOM 240 SS A1-2012 10/2012 Spanish
Additional Information
Document Number Published Language
Download 2012 Equivalency Agreement for Japan MX-005 01/2012 English
Download 2010 Equivalency Agreement for Canada and USA MX-006 10/2010 English
Download List of Deregulated Products MX-002 12/2014 Spanish
Download COFEPRIS notice on importing medical devices under renewal review MX-004 05/2014 Spanish