Mexico Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Mexico.

Major Regulations
	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

Specific Guidance Documents
	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

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