COFEPRIS medical device registration for FDA-cleared and Health-Canada-approved products. In-country titular; vía abreviada or standard review. 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.
Tecnovigilancia is not a PMS add-on. The COFEPRIS titleholder must run a UVT — named professional, written procedures, statutory AE clocks — and file the five-year Informe de Tecnovigilancia as part of registro renewal (NOM-240-SSA1-2012 §6.7.12; LGS art. 262 Bis, DOF 15 Jan 2026). If that system fails, the authority can suspend or cancel the registro, seize or freeze product, or prohibit use. A device without a live registro cannot legally stay on the market. Without a live registro, or if product is secured / use is prohibited, legal import stops. bioaccess® is the holder and runs that system on the USD 7,500 LATAM Launch Subscription.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. Mexico Class III / energy is USD 10,000/year. Includes government submission fees, sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families quoted on request.
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.