The 2025 Draft Regulations: Eight Parts Compared with S.I. 42 of 2024

1. Key takeaways

On 23 July 2025, NAFDAC published the draft NAFDAC Medical Devices, including In-vitro Diagnostics and Related Products Regulations, 2025, with a feedback window of 60 calendar days (until 20 September 2025) and the feedback address regulatoryaffairs@nafdac.gov.ng.

The draft is organized into Eight Parts, a fuller structure than the current S.I. No. 42 of 2024 (six Parts, 52 regulations):

Conclusion: this draft is the roadmap for Nigerian device legislation over the next one to three years, but it currently has no legal force.

2. Legal basis

3. Expert insights

Insight 1: moving from six Parts to eight Parts adds two whole Parts — clinical investigation and manufacturing.

The current regulation contains only six Parts; the draft expands this to eight Parts, and the two additions are precisely Part 2 on clinical investigation (14 regulations) and Part 3 on manufacturing (§17–§31). This marks a migration of Nigerian device legislation from registration and labelling control toward whole life cycle management. Companies that read only the current registration rules will therefore miss the direction in which the whole framework is heading.

Insight 2: the clause structure of the manufacturing Part is a complete codification of a QMS.

Part 3 includes: §18 quality system, §22 design controls, §23 validation and verification, §24 documentation, §25 production, §26 purchasing, §27 quality assurance and quality control, §28 contract manufacturing, §29 complaints and recalls, §30 quality audits, §31 handling of non-compliance with GMP. The structure corresponds closely to the elements of ISO 13485, and §30 on quality audits has no standalone counterpart in the current regulation.

Insight 3: the registration Part introduces several systems not covered by the current regulation.

Part 4 (§32–§47) includes: §32 classification, §34 refusal, §36 validity period, §37 suspension/withdrawal/cancellation, §39 novel devices, §40 post-registration changes, §41 renewal, §42 expert advisory committee, §43 obligations of the certificate holder, §44 reprocessing of single-use devices, §45 refurbishment, §46 registration of establishment, §47 disclosure. Of these, §44, §45 and §46 are entirely new systems with no counterpart in the current regulation.

Insight 4: the advertisement Part expands to 18 regulations (§61–§78), alongside labelling, storage and vigilance Parts.

The current regulation addresses advertisement in Regulations 28–47 (20 regulations) within its Part IV; the draft sets advertisement out as Part 6, §61–§78 (18 regulations). Although the counts are similar, the draft stands advertisement alongside labelling, storage and distribution, and vigilance as its own Part, making the system architecture clearer.

Insight 5: the correct use of the draft is as a production-planning signal, not as a compliance basis.

Across this 50-article series we have repeated one red line: the draft has not been gazetted and carries no current legal force. But for long-cycle decisions such as product design, QMS construction and clinical strategy, the draft’s directional value is extremely high — build the system to the draft, file the submission under the current law is the optimal strategy at present. Elements added to the QMS for draft compliance cost little while the design is still fluid, but retrofitting them after certification is expensive; the same logic applies to clinical evidence collected to Part 2 standards.

4. Practical recommendations

1. Set up a gazettal tracking mechanism for the draft and check the Federal Republic of Nigeria Official Gazette monthly.
2. Pre-build the QMS against the Part 3 elements (design controls, validation and verification, purchasing, quality audits) even though current law does not yet mandate them.
3. Prepare in advance the materials §46 registration of establishment may require, especially for local manufacturing projects.
4. Rehearse the clinical strategy against Part 2: GCP, ethics committees, safety reporting, and clinical investigations conducted abroad (see article 29).
5. For reprocessing of single-use devices (§44) and refurbishment (§45), run early compliance research if your portfolio is affected.
6. Mark every external document with the status of draft and not gazetted, and never mix citations with the current law.

5. Verification checklist

• □ A monthly gazettal tracking mechanism for the draft is in place (Official Gazette).
• □ The QMS element list has been pre-built against Part 3 (§17–§31).
• □ Materials for §46 registration of establishment have been pre-researched (if local manufacturing applies).
• □ The clinical strategy has been rehearsed against Part 2 (§3–§16).
• □ Applicability of §44 reprocessing and §45 refurbishment has been assessed.
• □ All external documents carry the note draft, not gazetted.

Regulatory information verified as of 29 October 2026. The content cited in this document comes from the NAFDAC 2025 draft regulations (published 23 July 2025, comment period until 20 September 2025, feedback address regulatoryaffairs@nafdac.gov.ng) and the current regulations (S.I. No. 42 of 2024, gazetted 16 October 2024, six Parts and 52 regulations plus the First Schedule). The draft has not yet been gazetted and carries no current legal force; this article is provided for regulatory direction only.

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