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.
The 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.
Determine the classification of your device according to the Ministry of Health’s classification rules.
Appoint a Mexico Registration Holder to manage your device registration and interact with COFEPRIS on your behalf.
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.
Prepare the registration dossier and application form according to the requirements of the applicable registration route for submission to COFEPRIS.
Pay the application fee. COFEPRIS reviews the application and may request additional information.
Upon positive review, COFEPRIS will issue a registration certificate for your device.
Log in to RAMS to view the chart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for Mexico when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.