In Depth: Mexico Medical Device Approval and Compliance


Posted 19 June 2015

Mexico has a population of 115 million people and is the fourth-largest device market in the Americas. This is a favorable market for medical devices, because the country relies heavily on imports. Medical devices in Mexico are regulated by the Federal Commission for Protection of Sanitary Risks (COFEPRIS). There are four major routes to registering a device in Mexico. In this video series we cover the routes, and more information important to the process.

In this slidecast:

  • Overview of the Regulatory Process for Medical Devices in Mexico [runtime = 2:53]
  • Determining Your Medical Device Classification [runtime = 2:38]
  • Key Players in the Approval Process [runtime = 2:03]
  • Registration Routes and Dossier Submission [runtime = 5:19]
  • Post-market [runtime = 2:38]

Related items:

Chart: Mexico COFEPRIS Approval Process for Medical Devices Mexico COFEPRIS Approval Process for Medical Devices


White paper: Device Registration with COFEPRIS in Mexico.