Nigeria Medical Device Regulations via NAFDAC

Regulatory Agency

National Agency for Food and Drug Administration and Control (NAFDAC) regulates medical devices in Nigeria.

Medical Device Definition

Medical Device: means any instrument, apparatus or contrivance (including components, parts and accessories thereof) manufactured, sold or advertised for internal or external use in the diagnosis, treatment, mitigation or prevention of any disease, disorder, abnormal physical state or the symptom thereof, in man or in animal.

Medical Device Classification System

International Classification	Risk Level	Examples
Class A	Low Risk	Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale
Class B	Low–moderate risk	Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask
Class C	High- Moderate risk	Blood glucose self-testing, ECG, X-ray Unit, Syringe, Condom, Contact lens
Class D	High risk	HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker

Regulatory Approval Process

Classification	Approval procedure
Class I Class II Class III Class IV	A written application for registration of imported medical devices should be made on the company’s letter head paper to the Director-General (NAFDAC), ATTENTION: The Director, Registration and Regulatory Affairs (R & R) Directorate, Ground Floor, NAFDAC Office Complex, Isolo Industrial Estate, Oshodi-Apapa Express Way, Isolo, and Lagos State. – The Application for the registration of all Medical Devices products should be submitted and processed on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal – https://registration.nafdac.gov.ng. – Upon successful screening of documentation and review of supporting documents, a Permit to Import shall be issued electronically via the NAPAMS Portal to the applicant for the importation of Registration samples for Laboratory testing. – Submission of Products for Laboratory Analysis. – Product Approval meeting. – For products approved at the meeting, an electronic Certificate of Product Registration is issued to the Applicant.

Classification

Approval procedure

Class I

Class II

Class III

Class IV

A written application for registration of imported medical devices should be made on the company’s letter head paper to the Director-General (NAFDAC), ATTENTION: The Director, Registration and Regulatory Affairs (R & R) Directorate, Ground Floor, NAFDAC Office Complex, Isolo Industrial Estate, Oshodi-Apapa Express Way, Isolo, and Lagos State.
– The Application for the registration of all Medical Devices products should be submitted and processed on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal – https://registration.nafdac.gov.ng.
– Upon successful screening of documentation and review of supporting documents, a Permit to Import shall be issued electronically via the NAPAMS Portal to the applicant for the importation of Registration samples for Laboratory testing.
– Submission of Products for Laboratory Analysis.
– Product Approval meeting.
– For products approved at the meeting, an electronic Certificate of Product Registration is issued to the Applicant.

Validity and Postmarket

Approval timeline

120 working days

License validity period

5 Years

Fees

Category 1 (Others except items in Category 2):

Local (NGN) – 20,000.00
Foreign – $750.00

Category 2 (Diapers and Sanitary Pads):

Local (NGN) – 20,000.00
Foreign – $874.00

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