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 ClassificationExamplesRisk Level
ACholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scaleLow
BPregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical MaskLow - Moderate
CBlood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lensHigh - Moderate
DHIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, PacemakerHigh
Premarket Approval Process
Class AClass BClass CClass 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
ValidityFive years
Postmarket Surveillance Sampling, monitoring, and vigilance controls in place.
Timeline3-6 months.
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