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

Ley General de Salud - General Health Law es MX-01112/2018
Reglamento de Insumos para la Salud - Regulation of Health Supplieses MX-01009/2012

Specific Guidance Documents

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

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
List of Deregulated Products es MX-00212/2014