Mexico Medical Device Regulations

Major Regulations
Document Number Published Language
Log in Agreement of 23 October 2012 2012
Log in Agreement of 22 December 2014
Log in Reglamento de Insumos para la Salud - Regulation of Health Supplies MX-010 09/2012
Log in Ley General de Salud - General Health Law MX-011 12/2018
Log in Agreement of 31 December 2011 2011 English
Specific Guidance Documents
Document Number Published Language
Log in Administrative Guide for the Integration of the Technovigilance Report
Log in Medical Device Labeling NOM 137 SS A1-2008 10/2008 English
Log in Technovigilance NOM-240-SSA1-2012 10/2012 English
Log in Good Manufacturing Practices NOM 241 SS A1-2012 11/2012 English