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	01/2013
Reglamento de Insumos para la Salud - Regulation of Health Supplies	es	MX-010	09/2012

General Guidance Documents


Document	Language	Number	Published
Criteria for the Classification of Medical Devices	en	MX-009	08/2010
Guidelines for Registration of Medical Devices	es	MX-008	09/2014

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
Criteria for Grouping Submissions Into One Submission	en	MX-003	09/2014
List of Deregulated and Low Risk Products	es	MX-002	12/2014

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