All documents listed below were published by Mexico's COFEPRIS or Secretaria de Salud and are in PDF format.
| 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 |
| 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 |
| 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 |
Mexico is one of the largest medical device importers in the world, making it an attractive market for foreign companies. The Federal Commission fo
read moreIf you are thinking about entering the Mexican market for the first time, understanding COFEPRIS’s regulatory requirements can be overwhelming. Inf
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