Medical Device Registration in
Nigeria
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:
English
Classification:
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:
Yes
License Validity:
5 years
Special Notes:
All official documents should be submitted in Originals and 2 sets of photocopies.