First Schedule Classification Rules 1 to 7 for Non-Invasive and Surgical Devices

1. Key takeaways

The true basis for classification in Nigeria is the First Schedule (Rules for Classification of Medical Devices) of S.I. No. 42 of 2024, not the four class names in regulation 3. The Schedule groups rules by device type. The key rules verified to date are as follows:

Non-invasive devices

• Rule 1 (devices in contact with injured skin): mechanical barrier only, for compression or absorption of exudates (first intention healing) → Class A; principally for wounds where the dermis is breached, including management of the wound microenvironment → Class B; wounds that can only heal by second intention → Class C;
• Rule 2(a) (devices for conveying or storing fluids or gases for infusion or administration into the body) → Class A, but where they may be connected to a Class B or higher powered device → Class B;
• Rule 2(b) (devices for conveying blood, storing or conveying other body fluids, or storing organs or tissues) → Class B, but blood bags → Class C;
• Rule 3 (devices that modify the biological or chemical composition of blood or other liquids for infusion into the body) → Class C, but where the treatment is filtration, centrifugation or gas and heat exchange → Class B;
• Rule 4 (all other non-invasive devices) → Class A.

Invasive devices for body orifices (non-surgically invasive) — Rule 5

• Not connected to a source device, or connected to a Class A device only: transient use → Class A; short-term use → Class B (except short-term use in the oral cavity as far as the pharynx, the ear canal up to the ear drum, and the nasal cavity, which remain Class A); long-term use → Class C (except long-term use in those three cavities where not absorbed by mucous membranes, which is Class B);
• Body-orifice invasive devices intended to be connected to a Class B powered device → Class B (irrespective of duration of use).

Surgically invasive devices — Rule 6 (transient use) / Rule 7 (short-term use)

• Rule 6: surgically invasive, transient use → Class B; but reusable surgical instruments → Class A; devices supplying energy in the form of ionizing radiation → Class C; devices with a biological effect or wholly or mainly absorbed → Class C; devices administering medicines in a potentially hazardous manner → Class C; devices specifically intended for direct contact with the central nervous system → Class D; devices specifically intended for diagnosis, monitoring or correction of defects of the heart or central circulatory system through direct contact → Class D;
• Rule 7: surgically invasive, short-term use → Class B, except where intended to undergo chemical change in the body (except devices placed in the teeth) → Class C.

2. Legal basis

3. Expert insights

Insight 1: Rule 1 splits wound dressings into three classes, using the medical judgment of healing mode.

The official examples under Rule 1 are very specific: bandages and absorbent cotton wool (Class A); non-medicated impregnated gauze and dressings (Class B); dressings for chronic ulcerated wounds and severe burns (Class C). The decision key is whether the wound can only heal by second intention — that is, where subcutaneous tissue is at least partly exposed, the wound edges cannot be approximated, and granulation must form before closure. Such rules are clinical judgments, not engineering judgments, and manufacturers must state the wound types in the intended purpose documentation.

Insight 2: the definition of connection under Rule 2(a) sits in the NOTE, the sentence most easily missed.

The official NOTE makes clear that connected means that the safety and performance of the powered device is affected by the non-powered device, or vice versa. Physical pluggability is therefore not the test; the question is whether the devices affect each other’s performance. This single sentence separates gravity infusion sets (Class A) from syringes and administration sets used with infusion pumps (Class B).

Insight 3: Rule 5 gives a lower class to three cavities — oral cavity to pharynx, ear canal to ear drum, and nasal cavity.

The same device in short-term use in these three cavities is Class A (Class B in other body cavities), and in long-term use without mucosal absorption is Class B (Class C elsewhere). This rule has the greatest impact on ENT, oral, urological and gynecological devices — for the same long-term mucosal contact, the nasal cavity and the trachea yield different results.

Insight 4: Rule 6 pulls reusable surgical instruments back from Class B to Class A.

Most surgically invasive transient devices (needles, lancets, single-use scalpels, staplers, surgical gloves, and the various catheters and suction tubes) are Class B, but reusable surgical instruments (such as hand-driven bone drill bits and saw blades) are Class A. An official NOTE adds that surgical instruments connected to a powered device are in a class higher than A. Manual plus reusable is Class A; powered plus single-use moves up.

Insight 5: the five escalation paths of Rule 6 lead to Class C or D, the watershed for orthopedic and cardiovascular products.

Ionizing radiation (including catheters with sealed radioactive isotopes), biological effect or absorbability, and administration of medicines in a potentially hazardous manner (such as insulin pens) → Class C; direct contact with the central nervous system (such as spinal puncture needles), and direct contact for diagnosis, monitoring or correction of defects of the heart or central circulatory system (such as angioplasty balloon catheters and their guidewires) → Class D. For orthopedic, interventional and neurosurgical projects, GRZAN’s first step is to work through these five escalation paths.

4. Practical recommendations

1. Complete the self-assessment form in four columns — rule number, applicable elements, resulting class, highest-class outcome — with a documented trail for each rule.
2. For wound devices, state first or second intention healing in the intended purpose statement as the evidentiary support for the Rule 1 determination.
3. When judging connection to a powered device, cite the mutual-influence test in the official NOTE, not the physical interface.
4. Run ENT, oral and nasal devices separately through the Rule 5 lower-class analysis, without mixing them with other body cavities.
5. For surgical instruments, first determine reusable versus single-use and whether connected to a source device, then apply the five escalation paths of Rule 6.

5. Verification checklist

• □ Each rule of the First Schedule checked in turn (rules 1–7 and any applicable subsequent rules).
• □ The determination basis for duration of use (transient / short-term / long-term) and site of contact recorded.
• □ Whether the device is connected to a powered device determined, with the official NOTE cited.
• □ The highest-class principle of regulation 3(2) applied, with the reason stated.
• □ Wound devices have the healing mode stated in the intended purpose.
• □ The five escalation paths of Rule 6 (radiation / biological effect / administration of medicines / central nervous system / cardiovascular) excluded or confirmed one by one.

Regulatory information verified as of 29 October 2026. The rules cited were checked against the regulation text published on the NAFDAC website (S.I. No. 42 of 2024, First Schedule, including examples and NOTE). Updates are re-checked whenever the regulations change.

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