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Mexico

The Medical Device Market in Mexico 2021

Introduction   Following our last Medical Device Market report for the Mexican Market in 2020, we present our report with …

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Mexico

Alternatives to register in Mexico a Medical Device with no Certificate of Free Sales.

Requirements to obtain a Medical Device Sanitary Registration in Mexico are well established. However, such requirements imply that the Ministry …

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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 …

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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 …

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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 …

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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 …

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