Impact of modifications proposed by COFEPRIS to current medical devices regulation

Last April 7th, 2021, Cofepris proposed to the applicable authority (CONAMER) a draft for changing current "Reglamento de Insumos para la Salud" (RIS) that is where the main regulation for medical dev

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What do you need for selling medical devices in Mexico?

If you are a medical devices manufacturer and are interested in selling / importing your medical devices to Mexico, then you want to continue reading. Medical devices are described under the Genera

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Clases of medical devices and grouping criteria

Classes: In Mexico there are 4 classes for Medical devices:

• IA – Low risk - there is a specific list and the device must be listed to be in this classification.
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Estimated Registration Times

Traditionally our MoH does not comply with the official times of registration, based on our experience (pre-COVID), we can give you an estimate from submission, of a 100% completed dossier, in Spanish

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Importation of health supplies without marketing authorization certificate (registration) in Mexico

Mexico has several equivalence agreements for marketing authorization regarding health supplies, which includes pharmaceuticals and medical devices, that have been published since 2010. Their targe

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Scope of the agreement published on June 22, 2021 for marketing authorization certificates for medical devices in Mexico

On June 22^nd of this year an agreement was published, which modifies the one published on January 28^th, 2020, on marketing authorization certificates through equivalence acknowle

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