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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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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 …

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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 …

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Mexico

Combination products and regulatory approach in Mexico

In general terms, combination products consist in a pharmaceutical product including chemical synthesis molecules, biologic or biotechnological API’s, that are …

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