Medical device registration in Nigeria is regulated by the National Agency for Food and Drug Administration and Control (NAFDAC). The agency is responsible for ensuring that medical devices that are imported or produced in Nigeria are safe and effective for use. NAFDAC provides the guidelines for registration of imported medical devices in Nigeria.

 

Steps to Register a Medical Device in Nigeria

The following steps are involved in the process of medical device registration in Nigeria:

1. Pre-registration:

   The manufacturer or importer of the medical device must submit an application to NAFDAC, which includes the product information, manufacturing details, and supporting documents.

2. Product evaluation:

   NAFDAC evaluates the safety, performance, and quality of the medical device, based on the information provided in the application.

3. Laboratory testing:

   NAFDAC may conduct laboratory testing of the medical device to verify its safety, performance, and quality.

4. Quality system assessment:

   NAFDAC may conduct a quality system assessment of the manufacturer’s facilities and processes to verify that they meet international standards.

5. Registration:

   If NAFDAC is satisfied with the safety, effectiveness, and quality of the medical device, it issues a certificate of registration, which allows the device to be sold in Nigeria.

The documents required for Medical Device Registration in Nigeria:

1. A notarized Power of Attorney by the product manufacturer appointing a local representative in Nigeria;
2. Certificate of Manufacture and Free Sale;
3. Comprehensive Certificate of Analysis;
4. Declaration of Conformity;
5. Validation/performance evaluation /Clinical Evaluation Report;
6. Colored Artwork / the Label of the Product;
7. Dossier;
8. Letter of Invitation for Good Manufacturing Practice Inspection;
9. The Product Images;
10. Evidence of trademark application/registration in Nigeria.

 

Registration Timeframe:

The registration process may take 2 – 3 months to complete.

 

Filing Language:

All documents must be in the English language, or translated into English.

 

Local Agent and Authorized Representative in Nigeria:

Foreign manufacturers are required by NAFDAC to have a local agent or an Importer of Record in Nigeria. The local agent should be appointed through a Power of Attorney.

 

License Validity:

The product license is for 5 years and may be renewed after expiration.

 

Contact:

Find out how we can help you with your medical device registration in Nigeria. Email us today at support@active-ip.com.