Colombia Medical Device Regulations

Agency
All medical devices are regulated by the National Food and Drug Surveillance Institute (INVIMA).
Classification of Medical Device
International Classification Examples Risk Level
Class I Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale Low
Class IIa Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask Low - Moderate
Class IIb Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens High - Moderate
Class III HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker High
Premarket Approval Process
Class I Class IIa Class IIb Class 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 required Provide test reports
Clinical data not required Submit 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
Validity Valid for 10 years, but there are exceptions.
Postmarket Surveillance Vigilance controls in place
Timeline Class 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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