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
Colombia allows multiple importers on a single INVIMA registration but only with the registration holder’s cooperation. INVIMA registrations last 10 years. bioaccess® holds the registration through our own Colombian entity.
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.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. 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 Colombia.