Registration in Mexico

CMC Medical Devices provides registration services for medical devices and IVD products in Mexico, supporting your entry into the Mexican market while ensuring compliance with COFEPRIS regulations.

Medical devices in Mexico are classified by risk (Class I–IV) and generally require a sanitary registration before they can be marketed. Registration involves submitting a dossier that includes technical documentation, labeling in Spanish, product classification, and supporting documents such as a Free Sale Certificate (FSC).

CMC can act as your local authorized representative, prepare and submit the dossier, assist with classification, labeling, documentation, obtention of the FSC, and guide you through communications with COFEPRIS.

With CMC, you can introduce your products to the Mexican market confidently and efficiently.