Changes in the medical device market in Mexico resulting from the COVID-19 (part II)

In recent months, due to the global pandemic, there have been several changes in medical devices market and its regulation in Mexico. In this article, we describe the most relevant changes that any regulatory affairs professional in the industry shall consider. You can also check our first update in this link.     Submissions to […]

How the regulation for Medical Devices in Mexico changed due to COVID-19

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Introduction   During the COVID-19 health contingency, various economic activities have been altered. The medical device industry is not an exception. Therefore, in this article we summarize how this sector has been affected in the latest months and what measures the health authorities in Mexico have taken. We will focus on specific medical devices that […]

New Cofepris submission guide

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  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 […]