Medical Devices Regulatory Support in Nigeria

Overview

The National Agency for Food and Drug Administration and Control (NAFDAC) is the key drug Regulatory Authority for regulating drugs and medical devices in Nigeria. The Agency was established by Decree No. 15 of 1993, as amended by Decree No. 19 of 1999. Now, the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria (LFN), 2004, is responsible for regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale, and use of drugs. All medical devices should be registered in accordance with the provisions of the NAFDAC Act CAP N1 (LFN) 2004, other related legislations, and the accompanying guidelines.

Medical Device Classification

In Nigeria, devices and IVDs are classified into four (04) classes. The devices falling into the same category and similar types of medical devices manufactured on the same premises can be grouped and applied under the same application form.

 

Medical Device Registration

Nigeria’s medical device regulations define medical device requirements, and unambiguous and clear procedures for registration, for both local as well as foreign manufacturers. The pathway toward launching a device in the Nigerian market is a multi-phased process and is as follows:

Step 1: Appointment of Medical Device Authorized Representative: All the foreign manufacturers intending to launch their devices in Nigeria shall appoint a local agent.

Step 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.

Step 3: Documentation: The duly filled product registration application form shall be submitted to the NAFDAC, along with necessary documents, such as the evidence of business incorporation, trademark registration, fee payment, CoA, manufacturing agreement, inspection/GMP report, product labels, and device details. The foreign manufacturers shall submit a notarized declaration, Power of Attorney, Free Sales Certificate (FSC), current GMP of the existing manufacturing facility, and a letter of invitation for the GMP Inspection. The applicant shall ensure that all the medical device registration requirements are complied with.

Step 4: Import Permit: In the case of foreign manufacturers, upon screening and review of the above-mentioned documentation, an import permit is issued.

Step 5: Sample Importation and Laboratory Analysis: The device samples shall be imported and submitted for testing. The payment evidence, the CoA, and evidence of vetting of product labels should be submitted along with the laboratory samples.

Step 6: Product Approval Meeting: After successful completion of laboratory analysis and GMP inspection, the applications are subjected to product approval meetings.

Step 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 submitted to the applicant.

Other Important Things to be Noted

• Trademark registration is mandatory before applying for the device registration, and a separate application shall be made to the Ministry of Industry, Trade, and Investment. If the application is found to have no conflicts and is deemed acceptable by the registrar, an acknowledgment letter or notice of acceptance will be issued to the applicant. This can be submitted, along with the product registration application form, to avoid delayed timelines for device registration.
• A registered product does not automatically qualify the product for advertising. An advertising permit shall be obtained, and a separate application must be filed to the Agency for this approval. The application can be submitted either with the product registration application or after the device is approved.

Product Maintenance & Compliance

Freyr Expertise

• End-to-end Nigeria Medical Device Registration
• Regulatory Consultation on Nigeria Medical Device Regulations
• Regulatory Support on Medical Device Regulations
• Sample Import Permit and Testing Co-ordination Services
• Trademark Registration
• Nigerian local Authorized Representation
• Advertising Permit Management
• Liaising with the NAFDAC
• Query Support Management till Approval
• Artwork & Labeling Management
• Post-approval Change Management
• License Renewal and Transfer