COFEPRIS medical device registration for FDA-cleared and Health-Canada-approved products. Vía abreviada 30–60 working days; standard 60–120 days. Single all-inclusive annual fee.
60–120 days (30–60 working days vía abreviada)
Mexico allows multiple importers on a single COFEPRIS registration but only with the registration holder’s cooperation. bioaccess® holds the registration through our own Mexican entity.
First device family low-to-mid risk USD 7,500/yr; Class III USD 10,000/yr. Additional families +USD 3,500 or +USD 4,500 per year.
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Mexico.