Mexico Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Mexico.
Related services for Mexico:
- Classification of Medical Devices in Mexico
- COFEPRIS Medical Device and IVD Registration and Approval in Mexico
- Mexico Registration Holder for Medical Devices
Related resources:
| 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 |
| 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 |
