INVIMA medical device registration for FDA-cleared and CE-marked products entering Colombia. Under Decreto 4725/2005, Class I & IIa receive registro sanitario automático (expedited issuance); Class IIb & III undergo full prior review (~90 business days). 10-year registration validity, 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.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
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.