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Colombia Medical Device Registration Fees
INVIMA government fees for 2025
COP 2,452,143
Low Risk Min
COP 4,209,087
High Risk Max
INVIMA
Authority
2025-09-17
Last Updated
Colombia (INVIMA) Fee Overview
Colombia (INVIMA) fees range from COP 2.4-4.2 million (~$560-$980 USD) depending on device class. IVD devices have separate, lower fees. A Colombia Registration Holder (CRH) is required for foreign manufacturers. Registration is valid for 5 years with renewal options. Colombia is part of Pacific Alliance harmonization efforts.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
MD Application - Class I | COP 3,718,704 | Per product |
MD Application - Class IIa | COP 3,718,704 | Per product |
MD Application - Class IIb | COP 4,209,087 | Per product |
MD Application - Class III | COP 4,209,087 | Per product |
IVD Application - Class I/II | COP 2,452,143 | Per product |
IVD Application - Class III | COP 3,269,447 | Per product |
Key Facts About INVIMA Fees
- 1Class I: COP 3,718,704 (~$870)
- 2Class IIa: COP 3,718,704 (~$870)
- 3Class IIb/III: COP 4,209,087 (~$980)
- 4IVD devices: COP 2.4-3.3 million (~$560-$770)
- 5Registration valid 5 years
Important Notes
- •MD devices: fees vary by class
- •IVD devices: separate fee structure
- •Different fees for Class IIa vs IIb
Tips for Colombia Registration
- 1IVD fees are lower than MD fees
- 2CRH selection is critical for market access
- 3Consider Colombia as Latin America entry point
Frequently Asked Questions
Government fees are subject to change. Last data update: 2025-09-17. Always verify current fees with INVIMA.