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