Medical Device & IVD Regulatory Registration in Colombia
Gain market clearance and sell your medical device or in-vitro diagnostics (IVD) product in Colombia
Before foreign manufacturers can legally sell their medical devices in Colombia, they must be in compliance with Colombian health regulations and registration requirements. Food, medical device, drugs, dietary supplements, and cosmetic products in Colombia are regulated by the National Institute for Medications and Food Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or INVIMA).
Get your INVIMA marketing authorization under your foreign entity's name, and retain ownership, control, and maintain independence from local distributors. We can become your authorized/registered agent/legal representative in Colombia and assist with the preparation and submission of your medical device registration dossier file/application to INVIMA. We will compile your technical and legal file, will review all labeling for compliance, and will provide post-submission assistance with INVIMA all the way through the approval of the device registration. The validity of your marketing authorization to sell your medical device in Colombia will be for 10 years. bioaccess™ can become your temporary IOR while you find a permanent IOR/distributor in Colombia. Read more.
Colombia's regulatory framework for medical devices.
Colombia is the best destination in Latin America for medical device first-in-human early feasibility clinical research studies and to commercialize their innovations.