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Colombia Medical Device Registration Fees
INVIMA government fees for 2026
COP 2,570,590
Low Risk Min
COP 4,412,400
High Risk Max
INVIMA
Authority
2026-01-12
Last Updated
Colombia (INVIMA) Fee Overview
Colombia (INVIMA) fees range from COP 2.6-4.4 million (~$600-$1,030 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 3,898,330 | Per product |
MD Application - Class IIa | COP 3,898,330 | Per product |
MD Application - Class IIb | COP 4,412,400 | Per product |
MD Application - Class III | COP 4,412,400 | Per product |
IVD Application - Class I/II | COP 2,570,590 | Per product |
IVD Application - Class III | COP 3,427,327 | Per product |
Trademark Application Range depending on type | COP 1,288,000 - 1,714,500 | Per application |
Key Facts About INVIMA Fees
- 1Class I: COP 3,898,330 (~$910)
- 2Class IIa: COP 3,898,330 (~$910)
- 3Class IIb/III: COP 4,412,400 (~$1,030)
- 4IVD devices: COP 2.6-3.4 million (~$600-$800)
- 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: 2026-01-12. Always verify current fees with INVIMA.