Guidelines for Registration of Medical Devices (Imported and Locally Manufactured) in Nigeria

Application

The Application for the registration or renewal of registration of all Medical Devices products required for each single medical device, medical device group, medical device family or medical device system should be submitted and processed on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal.

It is very important to state that a separate application form shall be submitted for each product.

Documentations

The following documents are required to be uploaded on the NAPAMS portal. After successful submission, all original documents listed below will be presented upon request:

1. The application letter addressed to the Director-General (NAFDAC), Attention: Director, Drug Registration & Regulatory Affairs Directorate, Ground Floor, NAFDAC Office Complex, Oshodi- Apapa, Express Way, Isolo, Lagos State.
2. Notarised Declaration. To be completed (typed), signed by Declarant and notarized by a Notary Public in Nigeria (for imported medical devices).
3. Power of Attorney or Contract Manufacturing Agreement. An applicant on behalf of a manufacturer outside Nigeria must file evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal, on all matters relating to the latter’s specialties. The Power of Attorney shall contain as follow:
4. Issued by the manufacturer of the product.
5. Signed by the Managing Director, General Manager, Chairman or President of the company, stating the names of the products to be registered. The power of attorney shall also indicate ‘Authority to register product with NAFDAC’.
6. State ownership of Brand name(s)/Trademark.
7. Notarized by a Notary Public in the country of manufacture.
8. Valid for at least five (5) years.
9. Contract Manufacturing Agreement: An applicant filing an application and being the owner of Brand name/Trademark, shall provide a Contract Manufacturing Agreement, which shall be signed by the applicant and the manufacturer. The Agreement shall be notarized by a Notary Public in the country of manufacture and signed by both parties stating names and designations of the signatories with the names of all the products to be registered and other relevant clauses clearly explained in an unambiguous language.
10. Certificate of Manufacture and Free Sale (for imported medical devices). The manufacturer must show evidence that the company is licensed to manufacture medical devices and that the sale of the product does not constitute a contravention of the laws of that country, i.e., Free Sale Certificate (Certificate of Manufacture and Free Sale). The Free Sale Certificate should:
11. Be issued by a relevant Health/Regulatory body in the country of manufacture
12. Indicate the name of manufacturer and products to be registered
13. Be authenticated by the Nigerian Embassy or High Commission in the country of origin. In countries where no Nigerian Embassy exists, any Commonwealth or ECOWAS country can authenticate the document.
14. 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 all relevant technical parameters of interest in addition the under listed information:
15. The brand name of the product
16. The batch number of the product
17. The manufacturing and expiry dates
18. The name, designation, and signature of the analyst.
19. Evidence of Business Incorporation by the Corporate Affairs Commission
20. Evidence of Registration of Brand Name with Trademark Registry in the Ministry of Industry, Trade and Investment. This should be registered in the name of the owner of the Trademark/Brand name
21. Product Labels/artwork should be in line with the labelling requirement under the Labelling Guidelines for Imported Medical Devices Section below
22. Letter of Invitation for Good Manufacturing Practice (GMP) Inspection (for imported medical devices): A letter of invitation to inspect the factory abroad shall be written by the manufacturer and shall state the following:
23. MANUFACTURER INFORMATION: Name of Company, full location address of factory (not administrative office address), e-mail, and current phone no. Details (name, phone number and email) of contact person overseas
24. LOCAL AGENT INFORMATION: Name of company, full location address, functional phone number. and e-mail address. Details (name, phone number and email) of contact person. Names(s) of product(s) for registration. 

Technical Documents

1. Declaration of Conformity

The manufacturer is required to attest that its medical device complies fully with all applicable Essential Principles for Safety and Performance as documented in a written “Declaration of Conformity” (DOC). At a minimum, this declaration should contain the following information:

a.         A statement that each device that is the subject of the declaration‒ complies with the applicable Essential Principles for Safety and Performance, has been classified according to the classification rules, and, has met all the applicable conformity assessment elements.

b.         A Global Medical Device code and term for the device(s).

c.         Date from which the Declaration of Conformity is valid.

d.         Name and address of the device manufacturer; and,

e.         The name, position, and signature of the responsible person who has been authorized to complete the Declaration of Conformity on behalf of the manufacturer.

1. Certificate of Compliance with Recognized Standards (where available) should be submitted
2. Product Dossier for In-vitro Diagnostics
3. Clinical Evaluation Report with Statistical Data for Novel Medical Devices including In-vitro diagnostics.
4. In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC), IMDRF/RPS WG/N13(Edition 2) FINAL:2019
5. Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVDMAToC), IMDRF/RPS WG/N9(Edition 3) FINAL:2019

Note: All technical documents must be submitted in electronic format e.g., Flash drive

GMP Inspection

It is advisable that the applicant should visit the Drug Evaluation and Research (DER) Directorate section of the Agency’s website for more Information on the Inspection of manufacturing facility (for both imported and locally manufactured medical devices)

Import Permit (for imported medical devices)

Upon successful screening of documentation and review of supporting documents, a Permit to Import shall be issued electronically via the NAPAMS Portal to the applicant for the importation of Registration samples for Laboratory testing.

Submission of Products for Laboratory Analysis

Upon importation of Registration Samples (for imported medical devices), applicants are expected to submit same to the division for onward submission to the Laboratory for analysis. The following documents are expected to accompany the samples.

1. Letter for submission of Laboratory Samples
2. Evidence of payment to the Agency
3. Certificate of analysis
4. Evidence of submission for vetting

While registration samples for locally manufactured medical devices will be drawn by Drug Evaluation and Research (DER) Directorate.

Product Approval meeting

Upon satisfactory Documentation review, GMP inspection of the production facility and laboratory analysis of product (where applicable), products are presented for the Food and Drug Registration Committee (FDRC) Approval Meetings.

Issuance of Notification

For products approved at the meeting, an electronic Certificate of Product Registration is issued to the Applicant.

Labelling Guidelines for Imported Medical Devices

Labelling should be informative, accurate and in conformance with the Agency’s Medical Devices, invitro diagnostic and other related products Labelling Regulations and any other relevant Regulations.

All imported and locally manufactured medical devices should bear the following minimum information on the label:

1. Name of the device
2. Name and address of the manufacturer
3. The identifier of the device, including the identifier of a device that is part of a system, test kit, medical device group, medical device
4. Family or medical device group family (where applicable)
5. Batch or lot number
6. If the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as size, net weight, length, volume, or number of units
7. The words “sterile” if the manufacturer intends to sale the device in a sterile condition
8. The words “for single use only” if the device is intended for that purpose
9. the manufacturing and expiry date of the device expressed in month and year (where applicable) unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including the performance specifications of the device if those specifications are necessary for proper use
10. the directions for use, unless directions are not required for the device to be used safely and effectively and
11. any special storage conditions applicable to the device
12. where a package that contains a device is too small to display all the information in

            accordance with (a-k) above, the directions for use shall accompany the device but need not be set out on the outside of the package or be visible under normal conditions of sell.

Failure to comply with the above listed requirements may result in the rejection of the application or lead to considerable delay in the processing of registration. This is why it is very important to appoint a well experienced Attorney when registering your product with NAFDAC in Nigeria.

Kindly note the following:

• A successful application will be issued a Certificate of Registration with a validity period of five (5) years.
• 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.
• NAFDAC reserves the right to revoke, suspend or vary a certificate during its validity period.
• Filing an application and/or paying an application fee does not confer registration status.
• 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
• The timeline for product registration from acceptance of submissions to issuance of Registration number is one hundred and twenty (120) working days.
• Please note that the clock stops once compliances are issued.

In order to conclude the registration of the product within a reasonable time, it is advisable that applicants provide all the necessary documents promptly and also in the specified form. One of the factors that delay the registration process is the manufacturer’s inability to provide the correct documents on time. All the documents listed above must be submitted at the time of making the application for registration. Most importantly, please note that NAFDAC will only accept documents in English language.

Note: The content of this article is anticipated to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstance.

By Adeola Oyinlade & Co.

Adeola Oyinlade & Co.; a leading full-service law firm in Nigeria provides help and offers advisory to both local and foreign clients on products registration with NAFDAC in Nigeria.

To see our service offerings, please contact us at [email protected] or visit www.adeolaoyinlade.com

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