Chapter 1 Nigerian NAFDAC Administration Information Abstract

1. Administration and Abstract

The regulatory body for the registration of medical devices in Nigeria is the National Agency for Food and Drug Administration and Control (NAFDAC), It is mainly responsible for the development of regulations, market access, and post-market supervision of medical devices.

2. Administrative Regulation

NAFDAC Act CAP N1 (LFN) 2004

3. Risk Level Classification of Medical Device and IVD Products

Medical devices in Nigeria are divided into Class A, Class B, Class C and Class D according to the risk level:

IVD products in Nigeria are divided into Class A, Class B, Class C and Class D according to risk level:

4. Registration Language

English.

5. Nigerian Representative

NAFDAC requires manufacturers to appoint a Nigerian representative to file the registration application. The representative must be an institution or individual legally registered in Nigeria and accredited by NAFDAC.

Chapter 2 Registration Flow

Chapter 3 Cycle & Official Fee

Registration period: The audit cycle of NAFDAC is about 8 months

Registration Fee: $874 USD/product

Chapter 4 FAQ

Q: How long is the validity period of the registration certificate of medical device products in Nigeria?

A: Five years.

Q: Does it require a QMS certificate for medical device registration in Nigeria?

A: The ISO 13485 certificate is required.

Q: Can the medical device products be changed after completing registration?

A: If the medical device product changes meet the requirements, registration changes can be made according to the procedure.