Introduction

Sanitary pads, baby wipes and diapers are classified as medical devices for registration purposes with the National Agency for Food and Drug Administration and Control (NAFDAC). NAFDAC registration is mandatory before these products can be legally imported, distributed, or sold in the Nigerian market. As a manufacturer or importer, understanding and adhering to NAFDAC’s guidelines for registration of baby diapers is therefore essential to gaining market access and avoiding sanctions.

This article provides a clear overview of the NAFDAC registration process for sanitary pads, baby wipes and diapers—outlining the key steps, required documents, and practical considerations to ensure full compliance.

Step-by-Step Guide for Registration of Baby Diapers With NAFDAC

To successfully register sanitary pads, baby wipes and baby diapers with NAFDAC, an Applicant should take the following steps:

1. Register your company or your business name with the Corporate Affairs Commission (CAC). For foreign companies not looking to set up a Nigerian company, appoint a registered local agent. The local agent acts on behalf of the foreign manufacturer and facilitates registration of the products.
2. Register your trademark or brand name with the Ministry of Trade and Investment.
3. Create an account on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS).
4. Write an application letter on the company’s letterhead to NAFDAC’s Registration & Regulatory Affairs (R&R) Directorate. An online application form is also to be purchased, completed and downloaded from the NAFDAC Product Registration Website. Note that a separate application form is to be completed for different products. Some details to be included in the form include:

• Manufacturer Information such as Name of the Company, full location address of the factory, email address, and current phone no. & fax no, the details of contact person overseas (name, telephone no, email address); name of airport closest to the location; and guide map illustrating the shortest land/air route to the factory overseas (where applicable)
• Local Company’s Tax Identification Number
• Details of Applicant, such as; name, contact, address, qualification, job title, warehouse address, etc.
• Number of products
• Details of the products, including types and sizes.
• Names of four (4) staff including production manager, production staff, quality control, and marketing director, where applicable.

1. Attach at least two (2) sets of the following documents to the application letter and printed application form:
2. Evidence of Business Incorporation. For Micro, Small and Medium Enterprises (MSMEs); evidence of Business name registration.
3. Notarised Declaration (for imported baby diapers). To be completed (typed), signed by Declarant, and notarized by a Notary Public in Nigeria.
4. Power of Attorney (POA), if applying on behalf of a manufacturer outside Nigeria. The POA should be valid for at least 5 years and must be signed by a senior company official. It must also be notarized in the country of manufacture; state the authority to register the product with NAFDAC and indicate ownership of the brand name or trademark.
5. Contract Manufacturing Agreement (CMA), where the applicant is applying on behalf of his company. The CMA should be signed by the Manufacturer and the Applicant, and must be notarized in the country of manufacture. The CMA should also state the names of all the products to be registered in a clear language.
6. Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry, Trade and Investment. This should be done in the name of the owner of the Trademark/Brand name as the case may be.
7. Evidence of satisfactory Inspection issued by the relevant Directorate or Good Manufacturing Practice (GMP) certificate for product line (for companies with registered products).
8. Product Labels/artwork.
9. Product Samples. See NAFDAC’s Laboratory Sampling Guide for more information on the quantity.
10. Comprehensive Certificate of Analysis. The certificate of analysis must be presented on a letter-headed paper of the Quality Control Laboratory where the sample was tested/evaluated and should contain the under listed information:
11. The brand name of the product
12. The batch number of the product
13. The manufacturing and expiry dates
14. The name, designation, and signature of the analyst.
15. Evidence of payment to NAFDAC.
16. Upon satisfactory documentation review, GMP inspection of the production facility and laboratory analysis of the products, they are presented for an Approval Meeting. Note that during the approval meeting, if the products’ labels do not meet the compliance requirements, compliant artworks may be submitted with a commitment letter from the manufacturer (stating that the commercial products will comply with the requirements).
17. If a product is successfully approved during the approval meeting, a Notification of Registration will be issued to the Applicant, while a Compliance Directive will be issued for products not approved.
18. Finally, the applicant for a successful product registration is issued a Certificate of Registration which is valid for 5 years.

How Much Does It Cost to Register Sanitary Pads, Baby Wipes and Diapers With NAFDAC?

Below is a schedule of the costs involved in registration of baby diapers with NAFDAC.

Table 1: Cost for Registration of Baby Diapers and Sanitary Pads with NAFDAC

How Long Does It Take to Register Sanitary Pads, Baby Wipes and Diapers with NAFDAC?

The timeline for registration of sanitary pads, baby wipes and diapers with NAFDAC, from acceptance of submissions to issuance of registration number is one hundred and twenty (120) working days, provided that all documents are provided timely and in their correct formats.

Conclusion

In conclusion, it is imperative to note that a successful registration of sanitary pads, baby diapers and wipes does not grant an advertisement permit of the product. Advertising permit is granted by the Registration and Regulatory Affairs Directorate, after careful evaluation of the claims made to ensure that exposed materials correspond to the approvals given.

Registering your sanitary pads, baby diapers and wipes with NAFDAC can help build trust with your target market and/or consumers by establishing your business as a reliable supplier of quality of these products.

Also see our article on NAFDAC Labelling Requirements for Medical Devices.