Mexico Medical Device and IVD Regulatory Approval Process

Medical and in vitro diagnostic (IVD) device manufacturers need to register their products with COFEPRIS, a division within the Mexican Ministry of Health (Secretaría de Salud). Unless exempted, medical devices require pre-market approval prior to market entry. 

Mexican COFEPRIS medical device approval process explained

The chart illustrates the COFEPRIS approval process per device classification in Mexico and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here. 

Step 1 
Determine the classification of your device according to the Ministry of Health’s classification rules.  

Step 2 
Appoint a Mexico Registration Holder to manage your device registration and interact with COFEPRIS on your behalf.  

Step 3 
All device manufacturers (except for certain low-risk devices) must show proof of an audited quality system as part of their registration application. If no acceptable certification is available, manufacturers may request Good Manufacturing Practices (GMP) certification from COFEPRIS according to Mexico’s GMP standard. 

Step 4 
Prepare the registration dossier and application form according to the requirements of the applicable registration route for submission to COFEPRIS.  

Step 5 
Pay the application fee. COFEPRIS reviews the application and may request additional information. 

Step 6 
Upon positive review, COFEPRIS will issue a registration certificate for your device.