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)
In Mexico, the registration holder can add multiple importers to a single COFEPRIS registration — but only if the holder cooperates. If a distributor holds the registration and refuses to transfer, you must re-register from scratch. bioaccess® holds all Mexican registrations through our own dedicated local entity, so you retain control of the registration and the ability to change distributors.
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.
The bioaccess® annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified Spanish translation of IFU, labels, and technical file. Electrical/EMC certification (e.g., NOM-208-SCFI-2016) and IFT RF homologation for wireless devices are separate authorities and are billed 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.