Mexico

Search
Close this search box.

Guides

Guides

sanitary registration holder in mexico

Mexico Holding Services guide

Classification and Grouping guide

Regulatory Affairs in Mexico guide

Blog

Mexico

Duplicate Medical Device Registrations in Mexico

Background   Obtaining a Sanitary Registration for a medical device in Mexico is a complex process that may take from …

Read More »
The Medical Device Manufacturer Definition
Mexico

The Medical Device Manufacturer definition (The Mexico case)

In general terms, a manufacturer is defined as a company who makes products. In some industries, such as in the …

Read More »
Mexico

Japan Equivalency Agreement for Medical Devices in Mexico

In previous articles and guidelines, we have explained the registration process for medical devices in Mexico though the so called …

Read More »
vitro mexico
Mexico

NOM 064 – Official Mexican Standard for in vitro diagnostics

Unlike other countries, in vitro diagnostics IVDs in Mexico are considered as medical devices and thus subject to general regulations …

Read More »
Mexico

Retroactive renewals for Medical Devices in Mexico

In recent months, COFEPRIS has been experiencing a series of changes with the aim of attending overdue requests. In this …

Read More »
applicable standards
Mexico

Applicable standards for Medical Devices

Medical devices are a broad group of products with different characteristics. Thus, many standards have been developed to establish general …

Read More »