Certificate of Manufacture and Free Sale (CMFS) for NAFDAC Registration

1. Key takeaways

Registration of imported devices in Nigeria requires one Certificate of Manufacture and Free Sale (CMFS), obtained through an explicit two-stage route: stage one is issuance, stage two is authentication:

1. Issuance: by the competent authority or the relevant health or regulatory body of the country of manufacture (country of origin);
2. Authentication: by the Nigerian Embassy or High Commission in the country of origin.

In a Nigerian application the CMFS serves a dual purpose: it evidences that the product is legally placed on the market in the country of origin, and it evidences that the manufacturer and the products named on the certificate match the present application.

A note on the verification boundary: no clause-level wording on the CMFS was found in the official NAFDAC regulations and guidelines reviewed for this article; the requirements above come from the practical document lists used in NAFDAC device registration and established industry practice. The specific formal requirements for the CMFS are therefore handled here as a practical estimate, and the current requirements must be confirmed with NAFDAC or the local entity before the certificate is arranged.

2. Legal basis

3. Expert insights

Insight one: the CMFS and the notarized declaration are two independent chains; neither can replace the other.

The notarized declaration answers the question of on what basis the applicant represents the manufacturer (executed by a notary within Nigeria). The CMFS answers the question of whether the product is lawful in the country of origin (issued by the authority of origin and authenticated by the Nigerian embassy or high commission there). The place of execution, the issuing body and the purpose of each document all differ; the absence of either one renders the application incomplete.

Insight two: embassy authentication is Nigeria’s general method of validating foreign documents.

This requirement is consistent with Nigeria’s established treatment of foreign public documents: documents issued abroad must be authenticated by the Nigerian embassy or high commission in the place of issue in order to have evidentiary effect in Nigeria. The processing time must therefore include embassy appointments, submission and collection, and the process usually starts earlier than the preparation of the technical documentation.

Insight three: the manufacturer name and product scope on the CMFS must match the application exactly.

Regulation 4(1)(b) requires the application to state the device name, class and identification information; Regulation 4(3) requires the administrative and technical information to be sufficient for the authority to make an informed decision. If the manufacturer name, address or product list on the CMFS differs from the application form, the ISO 13485 certificate or the labelling, a query will follow directly.

Insight four: the CMFS and the reliance pathway are complementary, not alternatives.

Regulation 14 and the reliance directives allow NAFDAC to take account of assessments performed by other authorities, but reliance does not mean exemption from documents. The CMFS, as evidence of lawful marketing in the country of origin, is still required under the reliance pathway (whether any waiver is possible must be confirmed case by case).

Insight five: the certificate has a validity period, and an expired certificate must be reissued — the easiest item to miss at renewal.

A CMFS usually carries an issue date, and some issuing authorities also state a validity period. The registration certificate is valid for five years; if the CMFS has expired by the time of renewal, it must be reissued and re-authenticated. GRZAN manages the CMFS validity and the certificate validity on a dual calendar precisely for this reason.

4. Practical recommendations

1. Start the CMFS before preparing the technical documentation (embassy authentication takes the longest).
2. Align the manufacturer name, address and product scope on the certificate word for word with the application form, the ISO certificate and the labelling.
3. Maintain a CMFS validity calendar, managed in parallel with the five-year certificate validity.
4. Confirm current formal requirements with the local entity before applying (this item is handled as a practical estimate).
5. Never treat the reliance pathway as a reason to omit the CMFS; confirm case by case.

5. Verification checklist

• □ The CMFS has been issued by the competent authority of the country of origin.
• □ The CMFS has been authenticated by the Nigerian embassy or high commission in the country of origin.
• □ The manufacturer name, address and product scope on the certificate match the application documents.
• □ The CMFS validity period is entered in the calendar (checked against the five-year certificate).
• □ Current formal requirements have been verified with NAFDAC / the local entity (practical estimate).
• □ Whether the CMFS remains required under the reliance pathway has been confirmed (case by case).

Regulatory information verified as of 29 October 2026. All citations above were checked against the registration guideline published on the NAFDAC website (VBM-R&RA-GDL-001-01 §3.0) and the regulation text (S.I. No. 42 of 2024, Regulations 4(1)(b) and 4(3)); no clause-level wording on the CMFS was found in the official regulations or guidelines, so its formal requirements are handled as a practical estimate.

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.