Understanding Medical Device Registration in Nigeria

Regulatory Authority

The Governing Council of the National Agency for Food and Drug Administration and Control (NAFDAC)

The National Agency for Food and Drug Administration and Control (NAFDAC) was established by Decree No. 15 of 1993 as amended by Decree No. 19 of 1999 and now the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004 to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of Food, Drugs, Cosmetics, Medical Devices, Packaged Water, Chemicals and Detergents (collectively known as regulated products). 

The Agency was officially established in October 1992. 

Link for Regulatory Authority

https://www.napams.org/

Link for Guidelines for MD Registration 

GUIDELINES FOR REGISTRATION OF IMPORTED MEDICAL DEVICES IN NIGERIA

Local Regulation

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

Classification of Medical Devices

Class A, B, C and D

Listing or Registration Requirements

1. Appointment of Medical Device Authorized Representative: All the foreign manufacturers intending to launch the devices in Nigeria shall appoint a local agent.
2. Trademark Registration: The brand name of the device in scope shall be registered with the Trademark Registry in the Ministry of Industry, Trade and Investment.
3. Documentation: The duly filled Product Registration application form shall be submitted to the NAFDAC, along with necessary documents such as, Evidence of business incorporation, Trademark registration, Fee payment, CoA, Manufacturing Agreement, Inspection / GMP report, Product labels and Device details. The foreign manufacturers shall submit Notarized declaration, Power of Attorney, Free Sales Certificate (FSC), current GMP of existing manufacturing facility and Letter of invitation for GMP Inspection. The applicant shall ensure that all the Medical Device registration requirements are complied with.
4. Import Permit: In the case of foreign manufacturers, upon screening and review of the above-said documentation, an import permit is issued.
5. Sample Importation and Laboratory Analysis: The device samples shall be imported and submitted for testing. The payment evidence, CoA and evidence of vetting of product labels should be submitted, along with the laboratory samples.
6. Product Approval Meeting: After successful completion of laboratory analysis and GMP inspection, the applications are subject to product approval meetings.
7. Nigeria Medical Device Approval: 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 for Nigeria Medical Device Registration

• The application letter and print-out of the registration form are to be accompanied with two sets of the following documents are to be submitted at the Liaison Office of the Director (LOD), R & R Directorate, or any NAFDAC Office (outside Lagos):
  • Evidence of Business Incorporation. In-case of Micro, Small and Medium Enterprises (MSMEs); evidence of Business name.
  • Evidence of payment to the Agency.
  • Contract Manufacturing Agreement (where applicable).
  • Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry, Trade and Investment. This should be done in the name of the owner of the Trademark/Brand name.
  • Evidence of satisfactory Inspection issued by the relevant Directorate or Good Manufacturing Practice (GMP) certificate for product line (companies with registered products).
  • Product Labels/artwork.
• Comprehensive Certificate of Analysis. The certificate of analysis must be presented on a letter-headed paper of the Quality Control Laboratory where the sample was tested/evaluated and should contain the under listed information:
  • The brand name of the product
  • The batch number of the product
  • The manufacturing and expiry dates
  • The name, designation and signature of the analyst 

Registration Timeline

3-6 Months

License Validity

5 Years

Registration Fee

https://www.nafdac.gov.ng/wp-content/uploads/Publications/NAFDAC-2019-Tariff_Final_Combined.pdf

Language Requirements  

All documents should be submitted in English

Additional Comments 

Trademark registration is required to request a license and should be requested ahead of time. An advertising permit should also be requested separately. 

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk