COFEPRIS medical device registration for FDA-cleared and Health-Canada-approved products. Equivalence route (vía abreviada) carries a ~30-working-day processing target for eligible devices; standard response times run ~30/35/60 working days by class. 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.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
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.