Introduction to Mexico's medical device approval process

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. Want to learn more about how to enter this market? This short video tells you how.

Topics covered include Cofepris (the agency that regulates medical devices), the classification categories in Mexico, appointing a registration holder, routes to approval, quality management systems in Mexico, testing reports performed in other countries, technical dossier, clinical trials conducted in other countries, the equivalency process for devices approved in the United States, Canada, or Japan, and more.

Helpful links:

• Free detailed chart about the medical device approval process in Mexico and how long it takes to gain approval.
• Download medical device regulations for Mexico.
• Extended video about obtaining medical device approval in Mexico.