All medical devices are regulated by the National Food and Drug Surveillance Institute (INVIMA).
Classification of Medical Device
||Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale
||Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask
||Low - Moderate
||Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens
||High - Moderate
||HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker
||Valid for 10 years, but there are exceptions.
||Vigilance controls in place
||Class I and IIa device should take less than 1 month. Class IIb and III devices may take up to 6 months.