Classification Disputes in New Zealand: No Medsafe Determination Route

Regulatory information verified as of 29 October 2026

1. Key takeaways

Medsafe states unambiguously: “If you are unable to determine the risk classification, refer to the manufacturer of the device. Medsafe is not able to make a determination as to the risk classification of a medical device.” New Zealand has no procedure where a company submits a classification for the regulator to rule on, and no dispute review channel.

The statutory duty closes on the Sponsor (New Zealand sponsor) side: reg 5(1)(a) of SR 2003/325 requires the classification entered in WAND, reg 7(a) a declaration that the product is correctly classified under the regulations, and reg 9 procedures ensuring compliance with regs 5, 6 and 8. Signing fixes classification responsibility on the Sponsor — it cannot pass to the manufacturer, nor to Medsafe.

When a dispute arises, the only path leads inwards: return to the 22 Schedule 2 rules, obtain written technical elements from the manufacturer, and adopt the more conservative class where alternatives cannot be excluded. IVDs are the exception — outside the 22 rules and the reg 5(2) identifier, uniformly using the code IVD (practical estimate). A wrong classification goes beyond the NZ$500 fine of reg 14; the real exposure lies in s 38 of the Medicines Act 1981 — the Director-General may require an importer or manufacturer to submit safety evidence within 45 days.

2. Legal basis

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

3. Expert insights

Insight 1: the boundary of is not able to.

Medsafe says cannot, not will not. Classification disputes carry no administrative determination, no pre-consultation letters, no EU MDCG-style interpretive documents. Put the question to Medsafe and the answer is: return to the rules and the manufacturer.

Insight 2: the official guidance has a gap; determination must rest on the regulation text.

The Medsafe page (Revised: 10 May 2011) groups the 22 rules into five: rule 1 definitions, rules 2–5 non-invasive, rules 6–9 invasive and implantable, rules 10–13 active implantable devices, and rules 14–22 particular kinds. This does not match the Schedule 2 headings: the official subheading for rules 10 to 13 is special rules for classifying active medical devices, the AIMD rule standing alone in rule 20; rules 14 to 22 sit under special rules for classifying particular kinds of medical devices. The web grouping is simplified presentation, not legal text; clause location must follow the original Schedule 2 headings. Even the official page’s grouping cannot serve as a classification basis, let alone foreign conclusions.

Insight 3: the six-step dispute route.

Step one, decide the path: IVDs are outside the 22 rules; Medsafe recognises no IVD risk model, IVDs use the code IVD uniformly, so the path ends there (practical estimate). For other devices, scan Schedule 2 in full, backwards from rule 22 to rule 2; anything not listed falls to Class I — documented rule by rule, never from experience. By official headings, Schedule 2 comprises: rule 1 definitions; rules 2 to 5 non-invasive; rules 6 to 9 invasive and implantable; rules 10 to 13 active medical devices; and rules 14 to 22 special topic rules — rule 14 medicines-incorporating devices, rule 15 contraception and STD prevention, rule 16 contact lens and device disinfecting or cleaning, rule 17 non-active diagnostic X-ray imaging recorders, rule 18 non-viable animal tissues or microbial or recombinant-derived materials, rule 19 blood bags, rule 20 active implantable devices (AIMD), rule 21 export-only, rule 22 breast implants. The AIMD entry is rule 20.

Step two, obtain three written elements from the manufacturer: intended purpose (per reg 3, as stated in accompanying information, instructions or advertising), duration (transient, short-term or long-term, per rule 1), and site of contact and mode of action — these decide whether the rules are hit.

Step three, re-check the 7 principles of reg 13 — by intended purpose, combination devices separately, accessories separately, software with its device’s class, non-body-part-specific devices by their most critical use, taking the highest where rules collide.

Step four, form an internal written determination table, second-person reviewed, archived with the manufacturer’s correspondence.

Step five, if unresolved, classify conservatively: take the higher candidate class, re-checking whether it triggers the reg 5(2) identifier duty and loses reg 5(3) grouping eligibility (practical estimate).

Step six, on any class change, correct the WAND record within 10 working days under reg 8.

Insight 4: the triple lock that keeps responsibility in-house.

First, the reg 7 declaration — by the Sponsor or its employee, that the product is a medical device in the regulatory sense and correctly classified under the regulations; a manufacturer’s opinion is only support material. Second, the principal’s liability under s 79 — acts of agents or employees are attributed to the principal, and each director and every person concerned in a body corporate’s management is likewise guilty if the act is proved authorised, permitted or consented to by them. Third, strict liability under s 80 — in a prosecution for selling a device contrary to the Act or regulations the prosecution need not prove intent; the defendant must prove absence of intent and that all reasonable steps were taken, and must serve written notice on the prosecution within 7 days of the summons, failing which it is not admissible.

Insight 5: why disputes should be resolved conservatively.

The notification-stage penalty is light — a fine not exceeding NZ$500 on conviction under reg 14. But a low classification places a high-risk device in a low-risk channel, and once a safety incident occurs the Director-General may issue a s 38(2) notice and the importer or manufacturer must submit safety evidence within 45 days. Failing the requirement, or continuing to sell after a further-evidence notice, carries under s 38(8) imprisonment not exceeding 6 months or a fine not exceeding NZ$5,000. That gap is the economic reason for a conservative resolution.

4. Practical recommendations

• GRZAN requires a written determination table for every product: hit or miss conclusions for each of the 22 rules, the three escalation factors’ values, and the seven reg 13 principles’ application — all archived.
• GRZAN recommends writing classification-information duties and response times into the Sponsor–manufacturer agreement, making consultation a contractual duty.
• Set up two-person review: determiner and reviewer separate, review records kept with the declaration signing date.
• Unresolved disputes: classify at the higher class and assess UPI and grouping eligibility simultaneously, avoiding rework (practical estimate).
• Every classification change enters the 10 working day correction trigger of reg 8, like name changes or lapse of certification.
• Put the determination table into the s 38 evidence pack, producible the moment a notice arrives.

5. Verification checklist

• □ The official Medsafe no-determination statement confirmed, page revision date archived.
• □ The 22 Schedule 2 rules fully scanned, documented rule by rule.
• □ Intended purpose, duration, site of contact and mode of action provided in writing by the manufacturer.
• □ The 7 principles of reg 13 re-checked and written into the determination table.
• □ The determination table is second-person reviewed and archived.
• □ Unresolved disputes classified at the higher class, UPI and grouping impacts assessed.
• □ Classification changes enter the 10 working day correction trigger of reg 8.
• □ The determination table is in the 45-day evidence pack under s 38.

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