Local Agent Documents: Notarized Declaration, POA and CMA in Nigeria

1. Key takeaways

The corporate-standing part of a Nigerian registration application is made up of three documents, with a brand-ownership-based choice between two alternatives for the third:

1. The Application Letter — addressed to the Director-General of NAFDAC, marked Attention: The Director, VBM-R&RA Directorate;
2. The Notarized Declaration — for imported devices, it must be notarized by a Notary Public in Nigeria;
3. The Power of Attorney (POA) or the Contract Manufacturing Agreement (CMA) — depending on brand ownership:
   • an applicant that is not the brand owner submits the POA;
   • an applicant that is the brand owner submits the CMA.

Together, these documents answer two questions: who in Nigeria is accountable for the product, and on what basis the applicant is entitled to act for the manufacturer. If either answer is weak, the application is incomplete even when every technical document is in order, because the authority cannot trace responsibility for the product it is being asked to register. These documents are also the ones most often prepared late, although notarization and agreement drafting each carry their own lead time.

2. Legal basis

3. Expert insights

Insight one: the notarization must be performed by a Nigerian notary; a foreign notarization is not automatically accepted.

For imported devices, the notarized declaration must be executed by a notary within Nigeria. This chain differs from the authentication route for the Certificate of Manufacture and Free Sale, which is issued by the competent authority of the country of origin and then authenticated by the Nigerian embassy or high commission there (see article 16 of this series). The two chains cannot substitute for each other, and planning them as one task is a common error. In practice the two tracks can run in parallel, but each needs its own owner, its own documents and its own deadline in the project plan.

Insight two: the dividing line between POA and CMA is brand ownership, not whether contract manufacturing is used.

Many companies reason that because they use a contract manufacturer they must submit a CMA. That reasoning is wrong. The official criterion is whether the applicant is the brand owner: a brand owner that entrusts manufacturing to another party submits the CMA; an applicant that is not the brand owner (for example a distributor or an authorised representative) submits the POA.

Insight three: the regulation defines the applicant as the person or institution formally applying for the certificate.

Regulation 51 provides: applicant means a person or institution or company that applies formally to the Agency to obtain a Certificate of Registration for a medical device. The definition does not require the applicant to be the manufacturer, so a distributor or authorised representative may act as applicant — but it must then complete the picture with the POA and the notarized declaration to substantiate its authority to act. The practical reading is that the applicant question and the authority question are answered by different documents and must both be evidenced.

Insight four: an incorrect addressee line on the application letter slows acceptance directly.

The contact format given at the end of the 2024 guideline is: Director-General (NAFDAC), Attn: The Director, Drug Registration and Regulatory Affairs Directorate. Since device functions have moved to the VBM-R&RA Directorate, the attention line should read Attn: The Director, VBM-R&RA Directorate. GRZAN verifies the current addressee and address at the start of every project before the letter is issued.

Insight five: the local entity’s duties extend beyond submission — post-market obligations sit on the same chain.

Regulation 12(4) requires importers, distributors and such authorised representatives to establish mechanisms for reporting user feedback to the manufacturer and the authority; Regulation 12(3) requires manufacturers and importers to comply with the authority’s pharmacovigilance provisions. When selecting a local entity, its post-market cooperation capability must therefore be assessed alongside its submission capability.

4. Practical recommendations

1. Fix the document combination first based on brand ownership (POA or CMA) before starting notarization, to avoid rework.
2. Have the notarized declaration executed within Nigeria, and run it in parallel with the embassy legalisation of the CMFS on a separate track.
3. Update the application letter addressee to the current directorate (The Director, VBM-R&RA Directorate) and verify the address.
4. Write post-market cooperation duties into the local entity agreement (vigilance, recalls, feedback reporting).
5. Manage POA/CMA validity periods actively, renewing before expiry and recording any corresponding variations.

5. Verification checklist

• □ The applicant’s status (brand owner / authorised representative) is confirmed and the POA or CMA selected.
• □ The notarized declaration has been executed by a Notary Public in Nigeria.
• □ The application letter is addressed to the Director-General, Attention: The Director, VBM-R&RA Directorate, with the address verified.
• □ The local entity agreement includes post-market cooperation duties (Regulations 12(3) and 12(4)).
• □ POA/CMA validity periods are entered in the renewal calendar.
• □ The local entity’s business qualification required by NAFDAC has been confirmed.

Regulatory information verified as of 29 October 2026. All citations above were checked against the registration guidelines published on the NAFDAC website (VBM-R&RA-GDL-001-01 §1.2 and §3.0; R&R-GDL-008-02 contact information at the end of the document) and the regulation text (S.I. No. 42 of 2024, Regulations 4(1)(b), 12(3)–(4) and 51); this page is reviewed whenever the regulations are updated.

GRZAN support for the Nigerian market: GRZAN coordinates local licensed import entities and authorised representative resources in Nigeria, covering online submission on NAPAMS, liaison for the Dossier Screening Clearance, import permits, sample delivery and laboratory analysis support. Service capabilities include classification decisions, selection of the registration pathway, preparation of technical documentation on the IMDRF ToC, handling of the CMFS and notarisation or legalisation, GMP and overseas inspection readiness, advertisement permits, vigilance and PMS reporting, variation management and renewal. Contact: hito.lin@grzan.cn; website www.grzan.cn.