Nigeria

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

Guideline

Official Language:      

English

Classification:    

Class A, B, C and D

Registration Process:

• 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.