Nigeria Medical Device Regulations

Agency

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

Premarket Approval Process

Class A	Class B	Class C	Class D
Appoint an authorized representative (AR) in NIgeria to submit application.
Fill out application form and submit all required documents (listed below).
If approved, applicant will receive a registration certificate

List of Required Documents

CFS
Quality system certification
Declaration of conformity
Description of device and intended use
Clinical and preclinical data

Additional Information

Validity	Five years
Postmarket Surveillance	Sampling, monitoring, and vigilance controls in place.
Timeline	3-6 months.

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