Nigeria - Register a Medical Device

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Procedure

Apply In-Person:

1. To apply for registering a Medical Device in person, the applicant has to visit the office of Director General of National Agency for Food and Drug Administration and Control.
2. The address and contact details of the office can be found in the “Office Locations & Contacts” section of this page.
3. Before visiting the office, the applicant needs to perform some pre-processes which are explained in further steps.
4. The applicant must prepare an application letter on the company letterhead addressed to the Director General for requesting to get the concerned Medical device registered.
5. Make sure that you have all the documents listed in the “Required documents” section of this page.
6. Then, a registration for the respective product must be obtained from NAFDAC by applying online in the following NAFDAC Automated Product Administration Monitoring System:register online
7. Click on the link and click on the “Register” button which will be present at the top in the homepage. Clicking that will automatically scroll down to the ‘Quick links’ section in which you can find ‘NAFDAC Client’ box.
8. Click the “Sign in” button below that and you will be directed to the login page. If you have an account already, enter the login details in the relevant fields and click “Login” button.
9. If not, click “ARE YOU NEW? REGISTER” link or click “Register” button present on the left side. Registration page will open.
10. Complete the ‘Company details’ section by entering the details in the respective fields provided and the ‘Company contact Information’ section with the contact of the concerned company.
11. In the ‘Applicant Information’ section, enter the names of the applying person and set a password for your account.
12. In the ‘Applicant Documentation’ section, one should upload the documents as required by clicking the “Choose file” button.
13. Once completed filling the application form with details required and uploading documents required, click “Save” button.
14. Successful company registration message will appear and an email with an account activation link will be sent to the email Id you provided.
15. Click on the activation link to activate your account. Your account is activated and you will be redirected to the login page.
16. Enter the login details and click “Login” button. In the homepage, you can find “Registration” form under ‘Navigation’ menu on the left side of the page.
17. Click on it and select ‘Application type’ as ‘New Product Registration’ and also select the category as ‘Medical Device’, Product source, Sub-category of products as applicable, then click “Continue” button.
18. Then, registration form for registering the product will appear. Complete the first tab with details about the concerned product and click “next” button.
19. Provide the name, contact and address details of the Manufacturer in the respective fields under the ‘Manufacturer Information’ tab and click “Next” button.
20. Clicking that will open the ‘Manufacturing Site Information’ tab, complete that with appropriate details, click “Add New Site” button and click “Next” button. You can also check the box present at the top if the Manufacturing Site Information is same as the Manufacturer Information.
21. In the next tab, use search box to search for the controlled substance if the product has controlled substancesand add it by clicking “Add” button.
22. If not, check the box present in the tab and click “Ok” in the popup to proceed. Click “Next” button, fill the fields about the product that appear further and click “Next” button again.
23. Further, upload the scanned copies of the required documents by clicking the “Choose file” button and click “next” button.
24. You have to pay the necessary amount of fees for the registration in the next tab, click on “Make Payment” button, Remita Retrieval Reference will be opened in which you have to click “submit” button.
25. Then enter your card number, date of expiry and CVV in the respective fields and complete the payment by clicking “Pay” button. After completion of payment, an invoice will be generated which you have to produce during the application.
26. In the next page, the product/application summary will be displayed, click View application button and print the form for submission.
27. Finally click “Submit” button and the online registration form has been completed.Attach all the required documents with the registration form print-out and application letter.
28. Visit the NAFDAC office and submit the application package to the Liaison Office of the Director (LOD).
29. After documentation review, required GMP inspection and Product analysis in lab, products are sent for approval meetings. For products labels with compliance issues, compliant artworks may be submitted with a commitment letter from manufacturer.
30. For products approved at the meeting, Notification of Registration is issued to the applicant while Compliance Directive is issued to those not approved.
31. Once all the requirements are met, the applicant will be issued a Certificate of Registration.

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Required Documents

Scanned copies required for online registration:

• Application Letter Stating Purpose for Product Registration [PDF]
• Certificate of Incorporation [PDF]
• Certificate of Analysis for Finished Product [PDF]
• Coloured Artwork /label of Product [JPEG]
• Current Good Manufacturing Practice (cGMP) [PDF]
• Evidence of Trademark Registration Duly Signed [PDF]
• Expired Licence for product Renewal [Optional] [PDF]
• Product Back view Image [JPEG]
• Product Front-view Image [JPEG]
• Product Inner View [JPEG]
• Product Side View [JPEG]
• Product Whole View Image [JPEG]

Documents to be submitted in-person:

• Certificate of Incorporation/proof of Business name
• Proof of payment
• Contract Manufacturing Agreement
• Proof of Brand name registration with Trademark Registry
• Successful Inspection report/Good Manufacturing Practice (GMP) certificate
• Product Labels/artwork
• Comprehensive Certificate of Analysis

For more clarifications, please refer ‘Documentation’ section in the following document: Link

Office Locations & Contacts

Registration and Regulatory Directorate - Head Office
National Agency for Food and Drugs Administration and Control
Address: Plot 2032, Olusegun,
Obasanjo Way, Zone 7, Wuse, Abuja,
Nigeria.
For Enquiries:
Tel: 0700-1-NAFDAC (0700-1-623322), +234(0)-1-4609750
Tel: 0800-1-NAFDAC (0800-1-623322) +234(0)909-763-0506, +234(0)909-763-0507
Email: [email protected]
NAFDAC Regional Contacts
Website: NAFDAC Homepage

Eligibility

• Any manufacturer, importer, exporter, advertiser, seller, distributor or a user of medical device, can apply.
• The applying company must possess an Incorporation Certificate and Tax Identification Number.

Fees

• Registration of a medical device approximately costs N20000.
  

Validity

• The registration is valid for a period of five years.
  

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The time line for product registration from acceptance of submissions to issuance of Registration number is one hundred and twenty (120) working days.
  

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• The application letter and print-out of the registration form are to be accompanied with two sets of the required documents are to be submitted at the Lagos office or any NAFDAC Office (outside Lagos).

• Ensure that scanned copies of documents to be uploaded during online registration do not exceed 500kb.

• Note that the Documents listed are based on the current requirement which may change based on NAFDAC regulations without prior notice and may be product specific.

• Applicants are advised to complete the application form neatly and completely with absolute legibility and appropriateness to avoid rejections. Also, all the required documents must be furnished completely.

Required Information

• Company Name and Type
• Tax Identification Number
• Registration Certificate Number
• Incorporation Date
• Company physical and mailing address
• Contact number and email address
• Applicant names
• Source and category of the product
• Product Description and HS code
• Manufacturer name and address
• Particulars of the product
• Card details

Need for the Document

• 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.
  

Information which might help

• Labelling should be informative, accurate and in conformance with the Agency’s Medical Devices Labelling Regulations and any other relevant Regulations.
• Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in the processing of registration.
• Registration of a product does not automatically confer Advertising Permit. A separate application and subsequent approval by the Agency shall be required if the product is to be advertised. Simultaneous submission of registration and advertisement applications is allowed.
• Failure to respond promptly to queries or enquiries raised by NAFDAC on the application (within 90 working days) will automatically lead to the closure of the Application.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• guidelines
  
• NAPAMS Help
  

Others

More information which might help people.