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.
For lower-risk devices INVIMA has reduced some registration requirements. Also INVIMA accepts Certificates of Free Sale (CFS) from manufacturers whose countries of origin are GHTF-founding members (i.e., Australia, Canada, European Union, Japan, and the United States).
Home-country approval is a prerequisite for market authorization in Colombia. Foreign manufacturers have the option to act as their own authorized representatives 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 Global Regulatory Overview Report service provides the following information:
- INVIMA Regulatory Background
- Product Assessment based on INVIMA Criteria
- Device Classification According to 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 Surveillance Requirements
Please contact us for further information on our Colombia Regulatory Strategy Consulting services.