Colombia Medical Device Regulatory Strategy Report
Colombia's medical device market is regulated by the National Food and Drug Surveillance Institute (INVIMA). In order to market your device in Colombia, you must obtain sanitary registration from INVIMA (unless the device type is exempt).
For lower-risk devices, INVIMA has reduced some registration requirements; INVIMA now accepts Certificates of Free Sale (CFS) from GHTF-founding member countries (i.e., Australia, Canada, European Union, Japan, and the United States) in place of certain required documents.
Home-country approval (or approval in a GHTF-founding member country) is a prerequisite for market authorization in Colombia. Foreign manufacturers have the option to maintain control over their registrations in the Colombian medical device market.
Let Emergo assist you in evaluating the Colombian medical device regulatory framework as it applies to your device(s).
Through our worldwide network of consultants, industry contacts, and regulatory sources, Emergo can provide in-depth analysis of all major medical device markets, including Colombia. Our Regulatory Pathway service provides the following information:
- INVIMA Regulatory Background
- Product Assessment and Classification Based on INVIMA Criteria
- In-Country Representation Considerations in Colombia
- Medical Device Registration Requirements
- Labeling and Language Requirements
- Costs and Timeframes
- Regulatory Roadmap for Colombia
- Post-Market Vigilance Requirements