NG(NAFDAC) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Nigerian NAFDAC Administration Information Abstract

Medical devices in Nigeria are uniformly regulated by the National Agency for Food and Drug Administration and Control (NAFDAC), which is a WHO-certified national regulatory body of Maturity Level 3 (ML3). Its core responsibilities include: formulation of medical device regulations, market access approval, supervision of production and import processes, post-market quality monitoring, and law enforcement management.

Regulatory Authority's Official Website Link:https://nafdac.gov.ng/

Regulatory regulations

NAFDAC Act CAP N1 (LFN) 2004

Classification of Risk Levels for Medical Devices 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:

Registration Language

English.

The local agent system

The NAFDAC mandates that foreign manufacturers must appoint a local Nigerian agent who is legally registered and recognized by NAFDAC. This agent is responsible for submitting the registration application and handling all subsequent communication matters.

Registration process, duration and official fees

Registration Flow

Standard process: Appoint a local registered agent in Nigeria → Determine the risk classification of the product → Prepare complete registration documents (enterprise qualifications, ISO 13485 certificate, free sales certificate, product technical data, etc.) → Submit the registration application to NAFDAC through the agent → NAFDAC conducts document review → Submit product samples for testing as required → If the review is passed, issue the registration/ listing notification; if not passed, issue a medical device compliance instruction.

Cycle Official Fee

Cycle

When the submitted materials are complete and compliant, the regular review cycle of NAFDAC is approximately 8 months.

Official Fee

Uniform official expenses: Medical devices other than diapers and sanitary pads are $750.00 per product; diapers and sanitary pads are $874.00 per 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.

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