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

DocumentLanguageNumberPublished
Ley General de Salud - General Health Law es MX-01101/2013
Reglamento de Insumos para la Salud - Regulation of Health Supplieses MX-01009/2012

General Guidance Documents

DocumentLanguageNumberPublished
Criteria for the Classification of Medical Devicesen MX-00908/2010
Guidelines for Registration of Medical Deviceses MX-00809/2014

Specific Guidance Documents

DocumentLanguageNumberPublished
Good Manufacturing Practicesen es NOM 241 SS A1-201211/2012
Installation and Preparation of Technovigilanceen es NOM 240 SS A1-201210/2012
Medical Device Labeling en NOM 137 SS A1-200810/2008

Additional Information

DocumentLanguageNumberPublished
2010 Equivalency Agreement for Canada and USA en MX-00610/2010
2012 Equivalency Agreement for Japanen MX-00501/2012
COFEPRIS notice on importing medical devices under renewal reviewes MX-00405/2014
Criteria for Grouping Submissions Into One Submissionen MX-00309/2014
List of Deregulated Products es MX-00201/2011
List of Down-Classified Products es MX-00101/2011