INVIMA medical device registration in Colombia for FDA-cleared and CE-marked products. In-country holder; 10-year registro. Single all-inclusive annual fee.
45–90 days
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. bioaccess® holds all Colombian registrations through our own dedicated local entity so this leverage never sits with a third party. 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 on the USD 7,500 LATAM Launch Subscription.
The bioaccess® annual subscription includes INVIMA government submission fees, in-country registered agent, regulatory liaison, and certified Spanish translation of IFU, labels, and technical file. Colombia CRC RF homologation for wireless devices runs through a separate authority and is 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 Colombia.