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Mexico

Regulation in Mexico for Medical Electrical Equipment

Medical electrical equipment (MEE) has their own requirements for safety and performance due to the nature of the electrical/electronic systems …

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Mexico

Classification and Grouping for Ultrasound systems in Mexico

As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping …

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Mexico

What COFEPRIS requires for the Certificate of Free Sale.

The Certificate of Free Sale (CFS), also known as “Certificate for Export” or “Certificate to Foreign Government”, is a document …

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Mexico

New amendments in the regulation for Medical Devices in Mexico

Last May the 31st 2021, the Ministry of Health in Mexico released an update to the Health Supplies Regulation. There …

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Mexico

Software as a Medical Device (USA, Europe, Canada and Mexico cases)

Technological advances in health care have placed software as an essential component of products and services for diagnostic and analysis …

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Mexico

About the regulation of previously owned medical devices in Mexico

The market of previously owned medical devices in Mexico works in different business models and therefore, arises questions about its …

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