INVIMA device registration in Colombia for FDA-cleared and CE-marked products. 10-year registro sanitario. One-time registration fee plus an annual holder fee.
2 days after document evaluation (Class I/IIa); 90 business days once the file is complete (Class IIb/III)
In Colombia, the registration holder can add multiple importers on a single INVIMA registration — but only with the holder's cooperation. Because INVIMA registrations last 10 years, distributors that hold your registration can effectively lock you out of the market for a decade. In Colombia, bioaccess® offers both models: (1) bioaccess®'s Colombian entity acts as registration holder (titular) for your devices, or (2) you hold the registration in your own name and bioaccess® acts as your legal agent (apoderado) in Colombia. Either way, that leverage does not sit with a distributor. See the LATAM Importer of Record guide for the full country breakdown.
Tecnovigilancia is not a PMS add-on. Colombia’s fabricantes e importadores must run an institutional program (Res. 4816/2008). If that system fails, INVIMA can suspend or cancel the registro, seize or freeze product, prohibit use, and — for controlled-tech equipment — suspend import and sale (Decreto 4725 art. 26). A device without a live registro cannot legally stay on the market. bioaccess® is the holder and runs that Programa Institucional as holder under the annual holder fee.
Two-part pricing for Colombia: a one-time registration fee of $4,000 (Class I), $6,250 (Class IIa or IIb) or $9,000 (Class III), then an annual holder fee of $3,900 from year 2. In Colombia, bioaccess® offers both models: (1) bioaccess®'s Colombian entity acts as registration holder (titular) for your devices, or (2) you hold the registration in your own name and bioaccess® acts as your legal agent (apoderado) in Colombia. 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. A Colombia-domiciled importer with an INVIMA storage certificate (CCAA) is still required; importer services are quoted separately.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Colombia.