Mexico Medical Device Regulations
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
| Document | Language | Number | Published |
|---|---|---|---|
| Ley General de Salud - General Health Law | es | MX-011 | 12/2018 |
| Reglamento de Insumos para la Salud - Regulation of Health Supplies | es | MX-010 | 09/2012 |
Specific Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Good Manufacturing Practices | en es | NOM 241 SS A1-2012 | 11/2012 |
| Installation and Preparation of Technovigilance | en es | NOM 240 SS A1-2012 | 10/2012 |
| Medical Device Labeling | en | NOM 137 SS A1-2008 | 10/2008 |
Additional Information
| Document | Language | Number | Published |
|---|---|---|---|
| 2010 Equivalency Agreement for Canada and USA | en | MX-006 | 10/2010 |
| 2012 Equivalency Agreement for Japan | en | MX-005 | 01/2012 |
| COFEPRIS notice on importing medical devices under renewal review | es | MX-004 | 05/2014 |
| List of Deregulated Products | es | MX-002 | 12/2014 |