REGULATORY AUTHORITY: Medical devices are regulated by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos).

CLASSIFICATION SYSTEM:

Medical devices: Class I, IIa, IIb, and III.

IVDs: Class I, II, and III.

TIMEFRAME:

Medical devices:

Class I, and IIa: 2-4 days.

Class IIb, and III: 3-6 months.

IVDs:

Class I, and II: 2-4 days.

Class III: 4-6 months excluding another 4 months if Specialized Board approval is also required.

LICENSE VALIDITY:

Medical devices:

Class I, and IIa:10 years.

Class IIb, and III: 5 years.

IVDs:

Class I, and II: 10 years.

Class III: 5 years.

LOCAL FEES (New Application):

Medical devices:

Class I, and IIa: ~. USD 750.

Class IIb, and III: ~. USD 850.

IVDs:

Class I, and II: ~. USD 485 to 3195*

Class III: ~. USD 645.

*The registration fees vary depending on the number of products included in the submission (maximum 15).

LICENSE TRANSFER: License transfer is possible. The application must be performed by the holder of the registration certificate by submitting a document so-called Ownership Assignment. In addition, an authorization of the manufacturer or AR must also be included in the application. This document is issued by the manufacturer or the AR to explain the relationship between the assignee and the manufacturer.

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Colombia.

ADDITIONAL INFORMATION: 

Both medical devices and IVDs that are going to be marketed in Colombia must obtain a registration certificate (registros sanitarios) unless they are exempted, hence, must obtain Certificado de no obligatoriedad de registros sanitarios.

Low risk devices are eligible for automatic approval while higher risk devices must pass technical evaluation before obtaining pre-market approval.

OTHER SOUTH AMERICAN COUNTRIES: Argentina, Brazil, Chile, Ecuador, Peru, Uruguay, Venezuela