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Nigeria Medical Device Regulations

Agency
National Agency for Food and Drug Administration and Control (NAFDAC) regulates medical devices in Nigeria.
Medical Device Definition
A medical device in Nigeria is any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material, or another similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
  • diagnosis, prevention, monitoring, treatment, or alleviation of disease;
  • diagnosis, monitoring, treatment, and alleviation of or compensation for an injury;
  • investigation, replacement, modification, or support of the anatomy or of a physiological process;
  • supporting or sustaining life;
  • control of conception;
  • disinfection of medical devices;
  • providing information  by means of an in-vitro examination of specimens derived from the human body;
And which does not achieve its primary intended action by pharmacological, immunological, or metabolic means in or on the human body but may be assisted in its intended function by such means.
Medical Device Classification System
International Classification Risk Level Examples
Class A Low Risk Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale
Class B Low–moderate risk Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask
Class C High- Moderate risk Blood glucose self-testing, ECG, X-ray Unit, Syringe, Condom, Contact lens
Class D High risk HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker
Approval Process
Classification Approval procedure
Class I
  • All medical device registration applications must be submitted through the NAFDAC Automated Product Management and Monitoring System (NAPAMS) Portal.
  • The application should accompany all the necessary documents like notarised declaration, power of attorney, free sale certificate, product labels, letter of GMP, certificate of compliance, clinical evaluation report, etc.
  • All technical documents must be submitted in electronic format e.g., Flash drive.
  • After verifying the details, the authority will provide an approval.
Class II
Class III
Class IV
Validity and Postmarket
Approval timeline 120 working days
License validity period 5 Years
Fees Category 1 (Others except items in Category 2):
  • Local (NGN) - 20,000.00
  • Foreign - $750.00
Category 2 (Diapers and Sanitary Pads):
  • Local (NGN) - 20,000.00
  • Foreign - $874.00
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