Introduction
Complying with the National Agency for Food and Drug Administration and Control (NAFDAC) labelling requirements for medical devices is a critical aspect of registering any medical device or in vitro diagnostic product, whether manufactured locally or imported into Nigeria. Proper labeling goes beyond meeting regulatory standards—it ensures market access, builds consumer trust, and drives business growth.
This article simplifies the important information required to be on the label of any medical device or in vitro diagnostics. Whether you are a new manufacturer or an importer, getting labeling right from the start can position your business for success, avoid costly mistakes and delays during registration.
NAFDAC Labelling Compliance for Medical Devices, In Vitro Diagnostics and Related Products
General Labelling Information for Medical Devices, Vitro Diagnostics and Related Products
All information required to be on the label of any medical device, in vitro diagnostic (IVD) and related product should be informative, clear and written in a manner that is easily understood. The information should also be in English Language and should state the following: –
- the brand name (where applicable).
- the product's statement of identity;
- batch or lot number;
- net content or net weight;
- manufacture, expiry date;
- manufacturer's name and location address including country of origin;
- NAFDAC registration number assigned to it in a manner as prescribed by the Agency
- Warnings and cautions
- direction for use
- storage conditions; and
- any other information as may be prescribed by the Agency.
Additionally, where a medical device, in vitro diagnostic (IVD) and related product container is covered with a packaging material, the label should be legible through the outer packaging material and should not be obscured by it.
In the same vein, labels of medical device, in vitro diagnostic (IVD) and related product should be affixed in a manner that is not removable from the medical device or related product container.
Furthermore, no label should bear words, pictorial or other means which refers to any other product or falsely suggests either directly or indirectly, that the medical device, in vitro diagnostic (IVD) and related product is connected with such other product. If there are any claims on the medical device, in vitro diagnostic (IVD) and related product, they should be substantiated.
Name and address of Manufacturer, Holder of Certificate of Registration, Packer on label
The label of any medical device, in vitro diagnostic (IVD) and related product should indicate the name and manufacturing address of the manufacturer. If a medical device, in vitro diagnostic (IVD) and related product is manufactured under a contract manufacturing arrangement, the name and manufacturing address should be indicated by a phrase that reveals the connection with the entity such as "Manufactured by" or "Manufactured for" or any other wording that expresses the facts.
The name and address of the manufacturer and packer of a medical device, in vitro diagnostic (IVD) and related product should be specified on the packaging component label (where present) in such a manner that is easily readable.
If a medical device, in vitro diagnostic (IVD) and related product undergoes any processing which affects its contents in another country, such a country should be considered as the country of manufacture for the purpose of labeling. Otherwise, such a country should be considered as the country of packaging for the purpose of labeling.
Furthermore, the address of the manufacturer should be complete on labels of all packaging components (i.e., Primary, Secondary and Tertiary), unless the immediate container is inadequate, in which case the address needs not be shown on the Primary label.
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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
