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Category: Medical devices

Which are the new low-risk devices that require marketing au- thorisation and which are no longer considered health supplies in Mexico? What does the medical device sector needs to know?

On July 7th, 2025, an agreement was published that brings...

medical devices

New agreement on the listing of medical devices

On July 7th, 2025, an agreement was published that brings...

The Medical Device Single Audit Program (MDSAP) in Mexico: A Revolutionary Initiative in Medical Device Regulation

The Medical Device Single Audit Program (MDSAP) represents a significant...

Health 4.0: Do You Know the Concept?

Revolutionising the Medical Device Industry What is Health 4.0? Health...

Do you know the characteristics of a Good Manufacturing Practices Certificate for the application for a Registration of foreign-manufactured Medical Devices in Mexico?

The Good Manufacturing Practices (GMP) Certificate is the legal document...

Concepts related to the classification of Medical Devices in Mexico

In Mexico, Medical Devices are classified according to the risk...

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Expertos en consultoría e inteligencia regulatoria y farmacovigilancia en Mexico. Especialistas en aprobaciones Medicamentos, Dispositivos Médicos y otros productos y servicios en Cofepris.

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