Medical Devices and Related Products: Definitions That Shape Filing Units

1. Key takeaways

The scope of the Nigerian Regulations is not a single concept but the compound expression medical devices and related products:

• Regulation 2 (Application): the Regulations apply to the registration, labelling and advertisement of medical devices and related products that are manufactured, imported, exported, advertised, sold, distributed, displayed for sale or used in Nigeria;
• Regulation 51 (Interpretation) provides the key definitions, including several concepts with direct consequences for filing structure:
  • Medical device family: a group of devices manufactured by the same manufacturer that differ only in shape, colour, taste or size, with the same design and manufacturing process and the same intended purpose;
  • Medical device group: a collection of devices sold under a single name, such as a procedure pack or tray;
  • Medical device group family: a group of device groups manufactured by the same manufacturer, carrying the same generic name (stating the intended purpose) and differing only in the quantity and combination of products contained in each group;
  • Test kit: an IVD device consisting of reagents or articles (or a combination) intended to be used to carry out a specific examination;
  • Personalized Medical Device: a device for a specific individual, which may be custom-made, patient-matched or adaptable;
  • Tertiary / Secondary / Primary packaging material: respectively, the transport outer box, the material enclosing the primary packaging, and the material in direct contact with the product.

2. Legal basis

3. Expert insights

Insight 1: the statutory boundary of a family requires all four qualifiers to hold simultaneously.

A medical device family requires the same manufacturer, differences only in shape, colour, taste or size, the same design and manufacturing process, and the same intended purpose. The hardest of the four conditions is the word only. Once a difference goes beyond these four attributes — for example, different materials, sterilization methods or performance parameters — the products no longer form a family, and separate applications must be filed.

Insight 2: the core of a group is the single-name procedure pack or tray; the core of a group family is variable quantity and combination.

A group (procedure pack or tray) is sold under a single name; a group family allows the quantity and combination of products to differ between groups, provided the generic name and intended purpose are identical. This is most useful for dressing trays and surgical packs: registering one group family buys, in one stroke, the freedom to configure different combinations for different hospitals.

Insight 3: personalized devices are already defined in the current Regulations, but the supporting rules sit in the 2025 draft.

Current regulation 51 already sets out the three forms (custom-made, patient-matched, adaptable), but no dedicated registration pathway provision exists. The 2025 draft adds a dedicated registration part in Part 4 (§32–47). Companies handling personalized devices should treat the draft as a forward-looking signal, not a current obligation (draft, not yet gazetted as of the verification date).

Insight 4: the statutory packaging-level definitions directly determine on which layer labelling obligations fall.

Tertiary (transport outer box), secondary (enclosing the primary packaging) and primary (direct contact with the product) are defined separately in the Regulations, and connect directly with the questions of where the registration number is marked (regulation 23), where constituents are marked (regulation 20), and where storage conditions are marked (regulation 22). Companies should first map their packaging levels clearly, then apply the labelling obligations layer by layer.

Insight 5: the Regulations contain no stand-alone definition of related products; in practice, NAFDAC’s classification approach governs.

The Regulations use related products alongside medical devices throughout, yet regulation 51 provides no independent definition of the term. GRZAN’s approach is to follow the classification shown on the NAFDAC website under the Products We Regulate section and in the registration guidelines, and to seek written confirmation where the boundary is unclear, rather than drawing conclusions on its own.

4. Practical recommendations

1. Determine the application unit at project initiation: single device, device group, device family or device system (regulation 4(1)(a)) — do not prepare the documentation first and decide the unit later.
2. Split into separate applications where differences within a family go beyond shape, colour, taste or size.
3. For trays and surgical packs, evaluate the group family pathway first, capturing the freedom of quantity and combination in one application.
4. File personalized devices under the current Regulations while tracking the progress of the 2025 draft.
5. Where the boundary of related products is unclear, seek written confirmation from NAFDAC and retain the reply.

5. Verification checklist

• □ Confirmed whether the product falls within medical devices and related products (regulation 2).
• □ Application unit selected: single device / group / family / system.
• □ Differences within the family do not exceed the four attributes of shape, colour, taste and size.
• □ For the group family, confirmed the generic name and intended purpose are identical, with only quantity and combination varying.
• □ Packaging levels (tertiary / secondary / primary clearly defined and used in applying labelling obligations.
• □ Unclear boundaries of related products have been confirmed in writing by NAFDAC (or listed for confirmation).

Regulatory information verified as of 29 October 2026. The provisions cited were checked against the regulation text published on the NAFDAC website (S.I. No. 42 of 2024, regulation 2, regulation 4(1)(a) and regulation 51) and the registration guideline (VBM-R&RA-GDL-001-01 §1.2, §1.4). Updates are re-checked whenever the regulations change.

GRZAN support for the Nigerian market. GRZAN provides NAFDAC registration and compliance support for the Nigerian market, with local resources covering coordination with licensed importers and authorized representative services, NAPAMS online submission, dossier screening permit liaison, import permits, sample delivery and laboratory analysis support. Service capabilities cover classification assessment, registration pathway selection, technical documentation to the IMDRF ToC, CMFS and legalization support, GMP and foreign inspection readiness, advertisement permits, vigilance and PMS reporting, variation management and certificate renewal. Contact: info@grzanglobal.com.