Novel Devices and Performance Evaluation Studies under Nigerian Regulations

1. Key takeaways

Nigeria’s treatment of novel devices is unambiguous: Regulation 5 conditions the registration of novel devices on obtaining a satisfactory performance evaluation study. This is not a request for supplementary data; it is a precondition — if the study is unsatisfactory, registration does not proceed.

Two companion provisions are equally important: Regulation 7 imposes a confidentiality duty on the information involved in such a study, and Regulation 47(2)(c) expressly lists a performance evaluation study as one of the six purposes for which an import permit may be obtained — because Regulation 47(1) prohibits the manufacture, import, export, distribution, advertisement, sale and use of unregistered devices, and without this provision the study samples could not enter the country at all.

The three provisions together form a complete chain: obtain the import permit for study purposes first, complete a satisfactory study, and only then discuss registration — with the study information protected by confidentiality throughout. Planning a novel device launch in Nigeria therefore starts with the permit application and the study protocol, not with the registration dossier; the dossier is built on the study results, and the study cannot even begin logistically until the permit is in hand.

2. Legal basis

3. Expert insights

Insight one: novelty in Nigeria is a question of registration conditions, not of classification. The Regulations do not give a closed definition of novel device, but they state its legal effect clearly: registration is conditional on a satisfactory performance evaluation study. For practical self-assessment we recommend three angles: first, whether a registered precedent of the same device type exists in Nigeria; second, whether the mechanism of action or technical route is new; third, whether the intended use goes beyond the range of already registered products. If any answer is yes, the product should be prepared as a novel device. Documenting the three answers at project initiation creates a defensible record of the pathway decision, which is useful both internally and in pre-submission dialogue with the Agency.

Insight two: the six purposes of Regulation 47(2) are the only lawful route for a novel device to enter the market. Regulation 47(1) prohibits the manufacture, import, export, distribution, advertisement, sale and use of unregistered devices — note that use is covered. Regulation 47(2) lists six purposes for which a permit may be obtained: (a) registration; (b) repair of devices; (c) performance evaluation study; (d) research; (e) use in an emergency; (f) humanitarian intervention donation. Novel device study samples go under (c); pure research collaboration goes under (d); urgent public health needs go under (e). Choosing the wrong purpose category will cause the permit application to be returned. The purpose stated in the application must match the study documents line by line, because reviewers check the correspondence first.

Insight three: Regulation 47(3) requires compliance with permit conditions — a permit is not an immunity pass. After obtaining the permit, the holder must still comply with the conditions stated on it. And Regulation 47(4): no person may deal with the device unless it is labelled as required by the Regulations; Regulation 47(5): its advertisement must not be displayed. In other words, a device in the study phase may enter the country and may be used, but may not be promoted. Marketing teams must understand that even product-neutral awareness material around a study device can cross this line, so study-phase communications should be legally reviewed.

Insight four: the confidentiality duty of Regulation 7 is a two-way signal. On one hand, performance evaluation study information submitted to NAFDAC is confidential, so companies need not fear leakage of technical details; on the other, this means the information will not become a publicly searchable precedent — you cannot infer the review yardstick for novel devices by reading other companies’ registration files, and case-by-case communication is the only channel. This is precisely where a local authorised representative delivers the highest value, since the dialogue about study design and acceptance criteria happens directly with the reviewing directorate rather than through published guidance.

Insight five: the 2025 draft gives novel devices their own §39, but the draft has not been gazetted. The draft published on 23 July 2025 contains §39 Novel devices in the Part 4 registration chapter, with supporting provisions such as §42 on the Expert Advisory Committee. However, the draft has not yet been gazetted and has no current legal force — we treat it only as a signal of regulatory direction: Nigeria is institutionalising novel devices, clinical investigations and expert committees. Current applications remain governed by Regulation 5 of S.I. No. 42 of 2024. Still, preparing the committee-facing materials now shortens the timeline if and when the draft becomes law.

4. Practical recommendations

1. Run the novelty self-assessment at project initiation, filing the three dimensions (domestic precedent, technical route, intended use) one by one.
2. Obtain the study import permit under Regulation 47(2)(c), stating the study protocol and sample size in the application documents.
3. Comply strictly with permit conditions; study-phase devices must not be advertised (Regulation 47(5)).
4. Structure the study protocol to the IMDRF framework, aligning objectives, statistical methods and acceptance criteria, and avoid reporting conclusions without data.
5. Discuss review expectations case by case through the local authorised representative, rather than relying on public precedent (Regulation 7 confidentiality).
6. Track the gazettal progress of draft §39 and §42, preparing in advance the materials an expert consultation might require.

For novel devices the regulatory calendar is dominated by the study, not the paperwork. Starting the permit and protocol work at least one full review cycle earlier than the registration target date is the single most effective scheduling decision available.

5. Verification checklist

• □ The novelty self-assessment is complete and filed (domestic precedent / technical route / intended use).
• □ Study samples were imported under a permit obtained per Regulation 47(2)(c).
• □ The list of permit conditions is known and embedded in internal SOPs.
• □ No advertisement of the device has been displayed in the study phase (Regulation 47(5)).
• □ Study devices are labelled as required by the Regulations (Regulation 47(4)).
• □ The performance evaluation report contains actual results, not merely a pass or fail conclusion.
• □ A tracking mechanism for the gazettal of draft §39 / §42 has been established.

Regulatory information verified as of 29 October 2026. All content cited above was checked against the official Regulations (S.I. No. 42 of 2024, Regulations 4(10), 5, 7, 47), VBM-R&RA-GDL-001-01 (§3.1, §11.6–§11.8) and NAFDAC-RDRR-005-04 (§2.1, §3.1.4–§3.1.5); the 2025 draft (§39, §42, §3–§16) was published on 23 July 2025 and has not been gazetted, carries no current legal force, and is referenced here only as a signal of regulatory direction.

GRZAN supports manufacturers entering the Nigerian market with registration documentation and conformity files, including classification determination, registration pathway selection, technical documentation to the IMDRF ToC, GMP and foreign inspection readiness, advertisement permits, vigilance and PMS reporting, change management and renewal. Local resources in Nigeria cover licensed import entities and authorised representative services, NAPAMS online submission, dossier screening permit liaison, import permits, sample delivery and laboratory analysis support. Contact: hito.lin@grzan.cn; website www.grzan.cn.