Mediqol

We’ve just finished a project with a client registering a device in Mexico and whilst a post on the full Mexican system might end up at 10 pages I thought it might be useful to provide a very brief analysis of the Mexican regulatory system!

The Federal Commission for Protection against Sanitary Risks (COFEPRIS) is the regulatory agency that acts under the authority of the Mexican Ministry of Health.

The system for medical device regulation is similar to many around the world in that it is based on classification and risk (I-III) with more information and evidence being required for products in the class III category. Approval times vary upon the classification and can take up to 6 months.

For assistance registering your products in Mexico please contact sarah.ramsay@mediqol.com