Nigeria - 2018 - Health

NAFDAC Registration and Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Medicinal Devices in Nigeria

Ministry of Industry, Trade and Investment, National Agency for Food and Drug Administration and Control, Nigeria

These guidelines are for the interest of the general public and in particular importers of medical devices in Nigeria. The document emphasizes that no medical device shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines. It provides information on the application for registration of imported medical devices, import permits, submission of products for laboratory analysis, issuance and labelling of imported devices.

Process Flow

Department of Registration and Regulatory Affairs

Office of the Director General NAFDAC

Office of the Permanent Secretary, Ministry of Health

Office of the Minister of State for Health

Office of the Minister of Health

Federal Executive Council

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NAFDAC Registration and Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Medicinal Devices in Nigeria Current Version

January 2022

These guidelines are for the interest of the general public and in particular importers of medical devices in Nigeria. The document emphasizes that no medical device shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines. It provides information on the application for registration of imported medical devices, import permits, submission of products for laboratory analysis, issuance and labelling of imported devices.

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