No Premarket Approval Requirement for Medical Devices in New Zealand

1. Key takeaways

No mandatory premarket approval exists for devices supplied in New Zealand; Medsafe states this directly. Explanation of the WAND Database says: “WAND is not an approval system for medical devices.” and “There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand.” In one line: no premarket approval, no registration certificate, no Medsafe technical review; WAND is a mandatory post-arrival notification database, not a premarket gate. After notification the company holds a database record; Medsafe has neither received nor assessed the product’s quality, safety, effectiveness or performance.

The legal origin is plain: the Medicines Act 1981 (1981 No 118) creates consent and provisional consent only for medicines, with no device equivalent. The device-relevant provisions are s 38 (restrictions on sale), s 40 (compliance with standards), Part 4 (advertising, from s 56) and s 37 (ministerial import prohibitions), all operating after the fact or in parallel, not as entry review.

With no review at entry, responsibility falls on the Sponsor (the New Zealand sponsor). Under reg 3 of SR 2003/325, the Sponsor is the person in New Zealand who exports, imports or manufactures the device; reg 6 requires WAND notification within 30 working days of becoming Sponsor; reg 7 requires a written declaration that the product is a medical device in the statutory sense, correctly classified under the Regulations, and recommended by the Sponsor only by intended purpose. The regulator does not endorse the product; from signature, every consequence of the declarations rests on the Sponsor.

WAND notification happens after the device arrives, not before. Three readings coexist: reg 6 states 30 working days from becoming Sponsor; What is WAND states 30 calendar days; the Regulatory requirements page states 30 working days from the day the device first arrives in New Zealand. The inconsistency is internal to Medsafe’s website; the statutory reading is reg 6. Because the anchor is post-arrival, notification cannot be a premarket gate, exactly what Medsafe’s no-approval statement implies. SR 2003/325 sets no prohibition on sale without notification; enforcement rests on the reg 6 and reg 8 time-limit duties plus the reg 14 penalty (not exceeding NZ$500); and the nine Schedule 1 exempt classes, including all IVDs, may be lawfully supplied without notification.

Enforcement is deployed entirely after the fact. Section 38 lets the Director-General, where there is reason to believe a device may be unsafe, issue written notice requiring safety evidence within 45 days; selling before the requirement is met attracts s 38(8): imprisonment up to 6 months or a fine not exceeding NZ$5,000. The duty of proving safety sits with the party closest to the product; the power of testing that proof stays with the regulator.

2. Legal basis

The instruments below underpin the position that no premarket approval exists.

3. Expert insights

Insight 1: Within one statute, medicines and devices are deliberately treated differently. The Act subjects new medicines to ministerial consent under s 20 before sale; devices, defined only from 1 July 2014 when s 3A was inserted by the Medicines Amendment Act 2013 (2013 No 141), have never received a corresponding licensing regime. The Medicines Amendment Act 2025 (2025 No 66) reinforced the split with the s 22A–22F medicines verification pathway, and paragraph 10 of the Ministry of Health’s February 2026 briefing states the “Verification Pathway only applies to medicines and not to medical devices”. Devices still travel the notification-plus-declaration path.

Insight 2: Medsafe’s disclaimer is written into s 38(5). Section 38(5) provides that non-exercise of the power is not a guarantee of safety. This closes the system’s logical loop: because there is no review, the regulator makes no express or implied endorsement of safety. Regulation 10 of the 2003 Regulations mirrors it: a manufacturer or Sponsor must not state that entry in the database is approval by the Director-General or the Ministry of Health of the product’s safety or fitness for purpose. Together the two rules lock responsibility for safety onto the Sponsor.

Insight 3: The criminal threshold is low, but the coverage is wide. Regulation 14 makes breach of any of regs 6, 8, 9 or 10 an offence carrying a fine not exceeding NZ$500 on conviction. The amount is modest; the scope covers four core duties: notification timing, information updating, procedures and marketing statements. Section 80 of the Act then establishes strict liability: in a prosecution for selling in breach of the Act or regulations, the prosecution need not prove intent; a defendant relying on absence of intent plus all reasonable steps must serve written notice on the prosecution within 7 days of the summons being served. Section 79 extends offences by bodies corporate to every director and every person concerned in management.

Insight 4: In an approval-free system, overseas approvals still have a role, but only as evidence. TGA, FDA, CE or UKCA approvals are not statutory entry conditions; no current instrument makes an overseas licence a condition of clearance or notification. Their value is evidentiary: when the Director-General requires safety evidence under s 38, documentation of approval by 2 or more recognised regulators is the most direct response material. Keep them in the standing technical file, not as an entry ticket.

4. Practical recommendations

• Translate no approval into self-borne responsibility. What New Zealand removes is review waiting time, not compliance duties. The reg 7 declarations will be read back line by line in any regulatory enquiry.
• Pre-stage the evidence pack for the 45-day s 38 window. Assembling documents only after notice arrives makes complete evidence within 45 days nearly impossible. GRZAN pre-organises risk analysis, clinical evaluation, overseas authorisations and vigilance data into a submission-ready safety evidence pack, with a named New Zealand contact to receive notices.
• Keep the verification pathway and the device path strictly apart. The consent by verification regime came into force on 19 November 2025 and applies to medicines. Where a combination product touches both tracks, each track should be handled by staff fluent in its own rules; timetables must not be cross-applied.
• Write the banned phrasing into the marketing handbook. Regulation 10 of the 2003 Regulations and reg 7 of the 1984 Regulations both prohibit claims of official approval. In GRZAN reviews, phrases such as approved by Medsafe or certified by the Ministry of Health go onto a red-line list, with compliant alternatives.
• Build daily record-keeping habits under strict liability. Given the reversed burden under s 80, whether the all-reasonable-steps defence succeeds depends on routine records; signatures, timestamps and external correspondence should all be filed.

5. Verification checklist

• □ Product confirmed as a device within the s 3A definition of the Medicines Act 1981
• □ Sponsor identity established; no reg 3(b) exclusion applies
• □ WAND notification complete; reg 7 declaration copy retained
• □ An s 38 evidence pack submittable within 45 days is ready
• □ A mechanism returns adverse reaction and complaint information to the Sponsor
• □ Promotional material is screened, with no implied official approval
• □ The s 80 strict liability structure and the 7-day defence deadline are understood
• □ Overseas approvals are evidence material only, never entry credentials

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