Medical Device Registration in


Ministry of Health:     

Federal Ministry of Health

Regulatory Authority:          

National Agency for Food and Drug Administration and Control (NAFDAC)

Medical Device Regulation:          

NAFDAC Act CAP N1 (LFN) 2004


Official Language:      



Class A, B, C and D

Medical Device Registration in Nigeria:

  • Appointment of Medical Device Authorized Representative
  • The brand name of the device should be registered with Trademark Registry.
  • The completed Product Registration application form shall be submitted to the NAFDAC, along with other necessary documents as below. The foreign manufacturers shall submit a Notarized declaration, Power of Attorney, Free Sales Certificate (FSC), current GMP of the existing manufacturing facility and Letter of invitation for GMP Inspection.
  • For foreign manufacturers, apply for an import permit.
  • The device samples will be requested and submitted for testing. The payment evidence, CoA and evidence of vetting of product labels should be submitted, along with the laboratory samples.
  • After the successful completion of laboratory analysis and GMP inspection, the applications are subject to product approval meetings.
  • If approved, a notification of registration or listing is issued to the applicant. In case the device is not approved, a medical device compliance directive will be issued to the applicant.

Documents Required:          

  • Notarised Declaration
  • Power of Attorney (PoA) or Contract Manufacturing Agreement
  • Certificate of Manufacture and Free Sale
  • Certificate of Analysis
  • Evidence of Business Incorporation
  • Trademark registration evidence
  • Product label or artwork
  • Letter of invitation for GMP inspection

Legalized/Notarised Documents (if any)      

Notarised Declaration

PoA or Agreement

Applicable QMS:          

ISO 13485 or GMP

Registration Timeline:         

3 – 6 months

Authorized Representative:          


License Validity:          

5 years

Special Notes:    

All official documents should be submitted in Originals and 2 sets of photocopies.

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