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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