Fast-Tracking for Medical Devices slashes the registration process from years to days
The Mexican Health Authority (COFEPRIS) reports that more than 30,000 medical devices have been registered through the fast-track option during the last two years. This is approximately 25% of the national market, and it includes photopheresis equipment, defibrillators, needleless drug injectors, cataract surgery equipment, X-Ray digitizers and drug testing reagents. Before fast-tracking, it took several years for the newest devices manufactured in other countries to be registered in Mexico. Through the fast-track option, the process takes about 30 working days.
This registration option was implemented by COFEPRIS in 2010 by means of equivalence agreements allowing products already cleared and commercialized for sale by the world’s leading medical device approval authorities – the U.S. Food and Drug Administration (FDA), Canada’s Health Canada (HC) or Japan´s Pharmaceuticals and Medical Devices Agency (PMDA) – to be sold in Mexico without meeting any additional substantial regulatory requirements.
Approximately 64% of the applications received by COFEPRIS are for the import of medical devices from the U.S., 33% from Canada and 3% from Japan.