Medical and in vitro diagnostic (IVD) device manufacturers must register their products with the National Food and Drug Surveillance Institute (INVIMA) to market their products in Colombia.
The Colombian INVIMA medical device approval process explained
The chart illustrates the INVIMA approval process per device classification in Colombia and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here.
Determine the classification of your device according to INVIMA’s classification rules.
Appoint a Colombia Legal Representative to manage your device registration and interact with INVIMA on your behalf. Alternatively, a qualified importer can submit the registration, but they may list themselves as the owner of the registration.
Prepare a registration application dossier for submission to INVIMA.
Pay the application fee. For higher-class devices, INVIMA reviews the application and may request additional information.
Once approved, INVIMA will issue a registration certificate for your device. For lower-class devices, INVIMA performs a post-approval review of the application and may request additional information.
Log in to RAMS to view the chart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for Colombia when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.