Colombia Medical Device Regulations

Agency
All medical devices are regulated by the National Food and Drug Surveillance Institute (INVIMA).
Classification of Medical Device
International ClassificationExamplesRisk Level
Class ICholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scaleLow
Class IIaPregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical MaskLow - Moderate
Class IIbBlood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lensHigh - Moderate
Class IIIHIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, PacemakerHigh
Premarket Approval Process
Class IClass IIaClass IIbClass III
Appoint an Authorized Representative (AR) in Colombia who will submit application. AR will be the owner of registration.
Submit application. Include proof of quality management and market approval (ISO 13485 and CFS or CFG).
Test reports not requiredProvide test reports
Clinical data not requiredSubmit clinical data
INVIMA will automatically approve application, however, further documentation may be requested. IN this case, applicant must provide documents within 30 days or they risk having approval revoked.Application will be reviewed. INVIMA may request further documentation at this stage.
If approved, INVIMA will issue registration certificate.
Additional Information
ValidityValid for 10 years, but there are exceptions.
Postmarket Surveillance Vigilance controls in place
TimelineClass I and IIa device should take less than 1 month. Class IIb and III devices may take up to 6 months.
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