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.
Questions? Request more information from our specialists
CONTACT USIn 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.
Related
-
Get smart about Mexico in 1 hour
If you are thinking about entering the Mexican market for the first time, understanding COFEPRIS’s regulatory requirements can be overwhelming. Inf
read more -
What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
read more