Mexico Regulatory Framework Medical Device registration

Mexican Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Mexican market:

Major Regulations

Regulation	Year
Ley General de Salud – General Health Law	2018
Reglamento de Insumos para la Salud – Regulation of Health Supplies	2012

Specific Guidance Documents

Document	Year
Good Manufacturing Practices (english)	2012
Good Manufacturing Practices (spanish)	2012
Installation and Preparation of Technovigilance (english)	2012
Installation and Preparation of Technovigilance (spanish)	2012
Medical Device Labeling	2008

Additional Information

Document	Year
COFEPRIS notice on importing medical devices under renewal review	2014
List of Deregulated Products	2014

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