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: –

1. the brand name (where applicable).
2. the product’s statement of identity;
3. batch or lot number;
4. net content or net weight;
5. manufacture, expiry date;
6. manufacturer’s name and location address including country of origin;
7. NAFDAC registration number assigned to it in a manner as prescribed by the Agency
8. Warnings and cautions
9. direction for use
10. storage conditions; and
11. 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.

Product identity

The label of a medical device, in vitro diagnostic (IVD) and related product should bear the name of the medical device or related product which should indicate the accurate nature of the medical device or related product.

Where a common name or statement of identity has been established for the product, it should be used in conjunction with the brand name. Otherwise, an appropriate descriptive name should be affixed to it.

Also, coined or fanciful names should not be misleading and should be accompanied by an appropriate descriptive term.

Composition/components

A complete list of composition or components of the medical device, in vitro diagnostic (IVD) and related product should be declared on the primary and secondary label where applicable in decreasing order of predominance. If there is no secondary packaging, the list of composition or components should appear on the primary label.

Additionally, composition or components in concentrations of less than 1% may be listed in any order after those concentrations of 1% or more. If there is more than one composition or component, the name of the composition or components should be included in the list of composition or components.

Furthermore, where a medical device, IVD and related product contains a pharmaceutically active composition or components, the declaration of composition or components should declare the active drug composition or components in accordance with the Agency’s extant Drug Labelling Regulations.

If the composition or components of a medical device, in vitro diagnostic (IVD) and related product is known to cause hypersensitivity, such should be declared on the label.

For multi-packs, if the composition or components are labeled on the outer packaging, they can be listed separately for each product or combined into one list. If labeling the outer packaging isn’t practical due to size or shape, the information should be provided on a leaflet, tag, tape, or card inside, with a reference or symbol on the outer packaging.

Also, if individual containers within the multi-pack are already labeled, no additional leaflet or tag is needed.

If the packaging is transparent and the product labels are clearly visible, no extra labeling is required.

Batch or Lot number

The batch or lot number should be indicated on all packaging components of medical device, in vitro diagnostic (IVD) and related product and where it is impossible, for reasons of size, for details of the batch or lot number to appear on all packaging components, the details should be given on the primary packaging.

6.Date marking instructions

The date marking should be stated for medical device, IVD and related product as well as the packaging components.

The batch number and date markings should not be pre-printed on the label.

Storage condition

The required storage condition should be specified on the packaging components.

Trademark and Brand name

The brand name or trademark should be displayed on the label and should not give a wrong impression of the nature or quality of the medical device, IVD and related product.

The brand name or trademark of a medical device, IVD and related product should not be a sound or look alike to an already registered medical device or related product. It should also not violate any regulation or requirements of NAFDAC.

NAFDAC Registration Number

The packaging component of a medical device, IVD and related product should clearly show the registration number (NAFDAC REG. NO.) of the product assigned to it by the Agency as indicated on the Certificate of Registration in a manner prescribed by the Agency. Usually, since the labels are required as part of the registration documents, the practice for most applicants is to only indicate a space where the NAFDAC Reg No. will be included after registration of the product has been approved.

Further, if a medical device has tertiary, secondary and primary packaging materials and the content of a unit pack is reasonably considered to be dispensed or sold to an end-user as a whole or is for a single use, the NAFDAC REG. No. should be shown on the tertiary and secondary packaging materials only. Where the primary package is a Trade Item, NAFDAC REG. NO should be assigned to the primary package.

Directions for use

The directions for use of any medical device or in vitro diagnostics should be included on the label to ensure correct utilization of the medical device or related product.

Warnings and cautions

The label of medical device, IVD and related product should carry clear and adequate warning to prevent any danger in the use of the product.

1. Net content

The accurate average net content or net weight of medical device, IVD and related product should be declared on the inner and outer label in the metric system. Medical device, IVD and related product that have only inner label should meet the same requirements as those for the outer labels of products having both an outer and inner label.

Conclusion

In conclusion, only relevant information should be on the label of a medical device, in vitro diagnostic and related products. Any misleading or deceptive information is considered an offense, and Individuals who violate these rules may face imprisonment of up to one year or fines up to N50,000, while corporate bodies can be fined up to N100,000. Also, upon conviction, offenders may be asked to forfeit any assets obtained through the offense.

Beyond avoiding penalties, complying with these requirements helps differentiate genuine products from counterfeit ones, protecting both consumers and the integrity of the pharmaceutical industry.

Kindly reach out to us with your enquiries on NAFDAC registration and labelling requirements.

Also see our article on NAFDAC LABELLING REQUIREMENTS FOR DRUGS AND PHARMACEUTICAL PRODUCTS IN NIGERIA