Overview of New Zealand’s Medical Device Regulatory Framework

1. Key takeaways

New Zealand device regulation rests entirely on a 1980s statute: the Medicines Act 1981 (1981 No 118), assented on 23 October 1981 and commenced on 1 August 1984 under the Medicines Act Commencement Order 1984 (SR 1984/142), current version 10 July 2026 on legislation.govt.nz. GRZAN verified the official text clause by clause: no premarket approval, no registration certificate, no technical review by Medsafe; WAND is a mandatory post-arrival notification database, not a premarket gate.

The first statutory duty comes from the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325): reg 6 requires the Sponsor to ensure the required information reaches the Director-General or the acting database maintainer within 30 working days of becoming Sponsor, with the reg 7 written declaration. The database, WAND (Web Assisted Notification of Devices), is established by reg 4 under s 105 of the Act, administered by the Ministry of Health.

Legally supplied has two meanings. Medsafe’s What is WAND page states: “For medical devices to be legally supplied in New Zealand they must be notified to the WAND database.” Yet SR 2003/325 nowhere prohibits selling an unnotified device; enforceable force lies in reg 6 (30 working days) and reg 8 (correction within 10 working days), with breaches under reg 14 fined up to NZ$500. Notification occurs after arrival, and the nine Schedule 1 exempt classes may be supplied without notification; failure to notify breaches a reg 6 time limit, not a sales ban.

The third layer, the Medicines Regulations 1984 (SR 1984/143), governs post-market conduct only: labels must state the manufacturer’s name or its New Zealand distributor’s name; advertisements must not claim official approval; material supplied or displayed with a device must contain no false or misleading statements. Entry is ungated across all three layers; responsibility rests on the Sponsor and force is delivered after the fact.

• One Act, two regulation sets, no approval layer anywhere.
• WAND notification is a post-arrival Sponsor duty, not premarket clearance.
• Schedule 1 exempts nine classes, including all IVDs.
• Post-market labelling, advertising and recall duties are enforced by penalties and safety powers.

2. Legal basis

The Act sets the framework and penalties; the 2003 Regulations the notification duties; the 1984 Regulations post-market conduct rules.

3. Expert insights

Insight 1: Why a forty-year-old law still stands. The Therapeutic Products Act 2023 (2023 No 37) was to replace the Medicines Act 1981, s 2(3) setting default commencement on 1 September 2026. The Therapeutic Products Act Repeal Act 2024 (2024 No 55) was assented 17 December 2024, commenced the next day, 18 December 2024, and s 3 repealed the TPA 2023; it repealed itself under s 10 on the 28th day after commencement, 14 January 2025. The successor Medical Products Bill had no Bill number before Parliament as at GRZAN’s verification date of 29 October 2026; officially, the Ministry of Health is still drafting. The 54th Parliament adjourned on 24 September 2026, dissolved on 1 October 2026, with the election set for 7 November 2026, blocking introduction this term. Official timelines conflict (2026 passage; June 2026 or early 2027 introduction; around-2030 commencement) and none is confirmed, so the Act remains the sole parent statute for the foreseeable period.

Insight 2: No premarket approval does not mean no barrier. Section 38 is the regulator’s strongest tool: where the Director-General has reason to believe a device may be unsafe, written notice may require an importer or manufacturer to supply safety evidence within 45 days (s 38(3)), with a further notice possible within 45 days of receiving that evidence (s 38(4)). Selling before the requirement is met attracts, under s 38(8), imprisonment up to 6 months or a fine not exceeding NZ$5,000. Section 38(5): non-exercise of the power is not a guarantee of safety.

Insight 3: The division between layers is easily misplaced. The notification duty is repeatedly misfiled under the 1984 Regulations; they contain no device definition clause and no WAND, notification or database provisions. The definition comes solely from s 3A; the notification duty solely from SR 2003/325.

Insight 4: The 2025 amendment touched medicines; devices were expressly excluded. The Medicines Amendment Act 2025 (2025 No 66) created a medicines-only verification pathway requiring full marketing authorisation from 2 or more recognised regulatory authorities; paragraph 10 of the Ministry of Health’s February 2026 briefing, Regulatory settings for medical devices, confirms devices are excluded. Do not borrow its timetable. 2026 medicine-side moves: the recognised regulators list was published by Gazette notice 2026-sl772 on 11 February 2026, (European Medicines Agency centralised procedure, Australia’s TGA, Health Canada, the US FDA, the UK MHRA, Singapore’s HSA, Swissmedic); the Medicines (Consent by Verification) Rules 2026 were made 20 May 2026, in force 3 July 2026; SL 2025/256 took effect 19 December 2025. All sit on the medicines track; check which track any claimed 2026 rule belongs to.

4. Practical recommendations

• Classify first, then schedule duties. Every GRZAN project starts with a s 3A and s 4 characterisation; notification planning begins only once the product is confirmed a device in the statutory sense. Skip it and rework follows.
• Schedule notification on the strictest reading. Reg 6 states 30 working days from becoming Sponsor; Medsafe pages alternatively state 30 calendar days and 30 working days from first arrival in New Zealand. Plan to 30 calendar days from first arrival (a practical estimate).
• Put the reg 9 procedures into writing. Reg 9 requires procedures ensuring continuing compliance with regs 5, 6 and 8; GRZAN implements them as a New Zealand notification management procedure covering ownership, time-limit triggers, change identification and evidence retention.
• Start post-market duties with the first shipment. The current New Zealand Medicines and Medical Devices Recall Code took effect 1 December 2015; Sponsors need written recall procedures, and initial reports of death or serious injury are due within 10 calendar days.
• Do not cite an unenacted law to clients. The Medical Products Bill was not before Parliament as at the verification date and official timelines conflict; it cannot underpin commitments or contract terms.

5. Verification checklist

• □ Product confirmed as a device within s 3A of the Medicines Act 1981, rationale retained
• □ Sponsor identity confirmed against the reg 3 definition and local-presence requirements of SR 2003/325
• □ WAND risk classification determined, with the manufacturer’s written confirmation on file
• □ Notification time limit and start point fixed on the strictest reading, owner assigned
• □ GMDN selection complete; IVDs confirmed to use the IVD classification and 5-digit codes
• □ Internal procedures covering regs 5, 6, 8 and 9 documented
• □ Labels checked against reg 12(4) of the Medicines Regulations 1984
• □ Recall procedures and adverse event routes established, including devices@health.govt.nz
• □ No external claim of having been approved by Medsafe

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 manages Medsafe sponsor obligations and WAND entry requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com