COFEPRIS medical device registration for FDA-cleared and Health-Canada-approved products. In-country titular; vía abreviada or standard review. Annual fee.
Depends on class; 30 business days by equivalence (vía abreviada, DOF 18 Jul 2025, art. 38)
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 under its contract with you, working with our local partner in Mexico, 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 as holder under the annual holder fee.
Two-part pricing for Mexico: a one-time registration fee of $5,000 (Class I), $8,000 (Class II) or $13,250 (Class III), then an annual holder fee of $4,500 from year 2. The registration fee includes initial government fees and certified/sworn translations up to a stated cap, and the first 12 months of holder service; see /market-access#pricing for caps and exclusions. USD, excluding VAT and local taxes; valid for agreements signed by 31 March 2027. Mexican testing, NOM certification and IFT RF homologation are not included and are quoted separately.
Technovigilance included: The annual holder fee includes technovigilance: adverse-event reporting to COFEPRIS, field safety actions (agency notification and relaying the field-safety notices you issue; executing a recall is quoted separately), and agency correspondence.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Mexico.