REGULATORY AUTHORITY: Medical devices are regulated by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos).
CLASSIFICATION SYSTEM: Medical devices are classified into Class I, IIa, IIb, and III; while IVDs are classified into Class I, II, and III.
TIMEFRAME: The licensing process takes around 2-4 days for low risk devices and 3-6 months for moderate and high risk devices.
LICENSE VALIDITY: Licenses for Class I and II devices expire after seven years; licenses for all other devices expire after five years.
SPECIAL REQUIREMENTS: Around 2-4 days for low risk devices and 3-6 months for moderate and high risk devices.
LOCAL FEES (New Application):
Medical devices (class I/IIa): USD 725
Medical devices (class IIb/III): USD 820
IVDs (class I/II): USD 480 to 3170*
IVDs (class III): USD 640
*the registration fees vary depending on number of products included in the submission (maximum 15).
LOCAL FEES (Manufacturer): N/A
Low risk devices (medical devices and IVDs): 10 years
Moderate and high-risk devices (medical devices and IVDs): 5 years
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.
AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Colombia.
Both medical devices and IVDs that are going to be marketed in Colombia must obtain 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.