Technovigilance for Medical Devices in Mexico


Introduction   Technovigilance or Medical Device Surveillance is the activity that guarantees that any medical technology in Mexico is correctly working and describes how to report any incident related to the device. In this text, we summarize the technovigilance requirements in Mexico. Specifically: How to identify an adverse incident, When to report and not report […]

New Cofepris submission guide

cofepris formatos

  Introduction Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document was released by the Sanitary Authorization Comission (CAS) –a division of COFEPRIS that approves Sanitary Registrations, Import Permits and other official authorizations. In this article we highlight the main features […]

Medical Device Regulatory Overview (Mexico)

Medical Device Regulatory Overview

Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless, there are a few considerations to register your products in the country. In this brief overview, we will describe what you need to register your medical device in Mexico and […]