Mexico COFEPRIS Regulatory Approval Process for Medical Devices and IVDs

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

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In Mexico, medical devices and In-Vitro Diagnostic (IVD) devices are governed by COFEPRIS, a division within the Mexican Ministry of Health (Secretaría de Salud).

The chart shown illustrates the COFEPRIS approval process in Mexico and is available for download from RAMS.