All medical devices are regulated by the Governing Council of the National Agency for Food and Drug Administration and Control (NAFDAC).
Medical Device Definition
A medical device means any instrument, apparatus or contrivance (including components, parts and accessories thereof) manufactured, sold or advertised for internal or external use in the diagnosis, treatment, mitigation or prevention of any disease, disorder, abnormal physical state or the symptom thereof, in man or animal. CAP N1 Laws, Art. 31.
Classification of Medical Device
|International Classification||Examples||Risk Level|
|A||Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale||Low|
|B||Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask||Low - Moderate|
|C||Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens||High - Moderate|
|D||HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker||High|
|Postmarket Surveillance ||Sampling, monitoring, and vigilance controls in place.|