Schedule 2 Classification Rules in New Zealand: 22 Rules Explained

Regulatory information verified as of 29 October 2026

1. Key takeaways

Risk classification in New Zealand is determined by regulation 12 of SR 2003/325: the classification is the result of the Schedule 2 rules as applied under regulation 13. Schedule 2 has 22 rules, of which rule 1 is interpretation; the operative rules run from rule 2.

The method works backwards from rule 22: first the particular-kind rules, then active devices (rules 10 to 13), then invasive and implantable devices (rules 6 to 9), then non-invasive devices (rules 2 to 5); a device raised by no rule falls into Class I. Rules 2 and 10 each carry a fallback — Class I unless another rule assigns higher — the terminus of the backwards method.

The AIMD rule sits in rule 20, not within rules 10 to 13; the latter address active devices, the former active implantable devices — different rule groups.

The seven subsections of principles in regulation 13 must be applied throughout. Medsafe makes no determination on classification; responsibility rests with the Sponsor (New Zealand sponsor) and the manufacturer.

New Zealand has no pre-market approval, issues no registration certificates, and Medsafe performs no technical review; WAND is a mandatory post-arrival notification database, and the only purpose of a classification conclusion is the risk classification field of the WAND record — no approval or certificate results. The 22 rules appear in full in SR 2003/325 Schedule 2 (official text at legislation.govt.nz); this article interprets them by topic.

2. Legal basis

The table below lists the sources verified and the provisions relied on.

3. Expert insights

Insight 1: apply the seven reg 13 principles before the 22 rules.

The subsections of reg 13 are principles to be applied throughout: (1) they must be applied when classifying under Schedule 2; (2) classification is by the intended purpose; (3) devices designed for use with other devices are each classified separately; (4) accessories are classified separately; (5) software and the device it drives share one classification; (6) a device not specific or primary to a body part is classified by its most critical specified use; (7) where 2 or more rules apply by intended purpose, the highest class is taken. Subsection (5) is critical for SaMD: software follows the device it drives; subsection (7) means scan everything and take the highest, not stop at the first hit.

Insight 2: rule 1’s three time thresholds are shared variables.

Rule 1 defines transient use as continuous use under 60 minutes, short-term use as 60 minutes to 30 days, and long-term use as more than 30 days. The invasive and implantable rules (6 to 9) rely on these thresholds, so the manufacturer must fix the duration of use in writing first.

Insight 3: the rules by topic.

• Non-invasive (rules 2 to 5): Class I by default; channelling or storing blood or body fluids entering the body, storing organs or tissues for implantation, or connecting to Class IIa-or-above active devices raises IIa; altering the biological or chemical composition of blood or other liquids raises IIb, except that filtration, centrifugation, gas or heat exchange therapy falls back to IIa; injured-skin contact is IIa, mechanical barriers, compression or exudate absorption fall back to Class I, and devices mainly for dermis wounds needing second-intention healing are IIb.
• Invasive and implantable (rules 6 to 9): body-orifice invasion grades across transient, short-term and long-term use, with fallbacks for the oral-to-pharynx, ear-canal-to-eardrum and nasal sites; connection to Class IIa-or-above active devices raises IIa. Surgically invasive devices grade by duration; direct heart or central-circulatory contact for diagnosis, monitoring, control or correction of deficiencies goes straight to Class III, while reusable surgical instruments fall back to Class I.
• Active devices (rules 10 to 13): Class I by default; therapeutic devices administering or exchanging energy are generally IIa, IIb where done in a potentially hazardous way; diagnostic devices are generally IIa, IIb where monitoring vital physiological parameters whose variation could cause immediate danger or emitting ionising radiation for interventional radiology; devices administering or removing substances are generally IIa, IIb where the manner is potentially hazardous.
• Particular kinds (rule numbers per the official text): medicines-incorporating devices, devices with animal, microbial or recombinant-derived materials, and breast implants point to Class III; contraceptive and STD-prevention devices (implantable or long-term invasive ones raised to Class III), contact lens and device disinfecting products, and blood bags point to IIb; non-active diagnostic X-ray imaging recorders point to IIa; export-only devices point to Class I.
• Active implantable devices (rule 20): AIMDs point to AIMD; their implantable accessories, and active devices controlling, monitoring or directly influencing AIMD performance, point to Class III.

Insight 4: an executable backwards workflow.

GRZAN recommends five steps: fix the inputs (intended purpose, duration, site of use, connection to active devices); scan the particular-kind rules with rule 20; then rules 10 to 13 or 6 to 9; then rules 2 to 5; finally take the highest of all hits under reg 13(7).

Insight 5: no official determination route; foreign conclusions cannot be copied.

Medsafe expressly makes no determination; where a device cannot be classified, consult the manufacturer. The conclusion must therefore be formed and documented by the Sponsor itself, and if later challenged the evidence comes from within the company, not the regulator. The reg 11 ordering also means a raised classification may trigger the extra UPI requirement of reg 5(2).

One hard boundary remains: EU MDR or Australian TGA conclusions cannot be applied directly. The official Medsafe text reads: “Recent or planned changes to risk classification systems in Europe and Australia mean there are now differences between risk classifications in those regulatory regimes and New Zealand.” New Zealand always follows the 22 local rules of Schedule 2.

4. Practical recommendations

• GRZAN’s first deliverable is a determination table recording intended purpose, duration, site of use, connection to active devices, rules hit, resulting class and basis — also the core evidence for the reg 7 declaration and later disputes.
• GRZAN requires written manufacturer confirmation of the class; unilateral Sponsor inference is not accepted. Medsafe makes no determination, so an understated class makes the reg 7 correct-classification statement the direct point of liability.
• Duration must be fixed in writing by the manufacturer into one of rule 1’s three bands (under 60 minutes / 60 minutes to 30 days / over 30 days).
• Determine combination products, accessories and software separately under reg 13(3)–(5); never merge them into one record.
• Where multiple rules are hit, take the highest under reg 13(7); the table lists all hits, not only the final class.
• After the determination, loop back to reg 5: Class III and AIMD need the UPI in advance; Class I, IIa and IIb can be assessed for grouping under reg 5(3).

5. Verification checklist

• □ Basis confirmed as reg 12 + Schedule 2, with the 7 principles of reg 13 applied throughout.
• □ Intended purpose fixed in writing, per reg 13(2).
• □ Combination devices classified separately (reg 13(3)), accessories separately (reg 13(4)), software sharing its device’s class (reg 13(5)).
• □ EU MDR and Australian TGA conclusions not applied directly.
• □ Duration fixed into one of rule 1’s three bands (60 minutes / 30 days).
• □ The 22 rules scanned in the order particular kinds, active, invasive or implantable, non-invasive.
• □ Highest class taken under reg 13(7) where multiple rules were hit.
• □ Conclusion confirmed in writing by the manufacturer; Medsafe’s no-determination stance explained to management.
• □ Conclusion looped back to reg 5(2) (UPI) and reg 5(3) (grouping).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the New Zealand market. Our team prepares WAND-compliant evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com