Technical Documentation in New Zealand: No Pre-market Review, but a 45-Day Duty

Regulatory information verified as of October 29, 2026.

1. Key takeaways

Yes, prepare it — and in a state of constant deliverability, not assembling-later. New Zealand genuinely does not review technical documentation for medical devices before market entry: Medsafe states on its official WAND (Web Assisted Notification of Devices) page that there is no mandatory approval requirement before supply. The duties have not disappeared; they have shifted from submitting in advance to proving afterwards.

The shift is accomplished by s 38 of the Medicines Act 1981 (1981 No 118): where the Director-General has reason to believe a device may be unsafe, he may give written notice to an importer or manufacturer in New Zealand requiring proof of safety, to be supplied within 45 days (or any longer period allowed). Selling before complying, or before notice satisfactory to the Director-General, is an offence under s 38(8) punishable by up to 6 months imprisonment or a NZ$5,000 fine. Section 38(5) adds a sentence of enormous weight: the Director-General’s failure to exercise the power must not be taken as a guarantee of the device’s safety.

GRZAN’s conclusion: the 45 days is the most real time requirement New Zealand places on technical documentation. It does not ask you to submit; it asks you to produce when asked.

The official statements go further. Paragraph 6 of the Ministry of Health briefing to Ministers H2026079100, Regulatory settings for medical devices (26 February 2026), states that devices supplied in New Zealand face no pre-market evaluation or approval, that suppliers need not demonstrate approval by any overseas regulator, and that the only requirement is notification to Medsafe through WAND; paragraph 7 calls market introduction effectively no regulatory barriers. It is a policy briefing, not a source of law. GRTPNZ Ed 2.0 (May 2024) §4.1.1 agrees: pre-market evaluation and approval is not currently required for medical devices; more notable is §4.1.2 — Medsafe recommends compliance with applicable ISO standards, a recommendation, not a mandate. One wording needs untangling: Medsafe’s WAND home page also says devices must be notified to WAND to be lawfully supplied, but SR 2003/325 sets no prohibition on sale without notification; the coercive force lies in reg 6’s 30 working day notification duty and reg 8’s 10 working day correction duty, breach carrying under reg 14 a fine of up to NZ$500; notification occurs after arrival, and the 9 exempt categories of Schedule 1 may be lawfully supplied without notification. Failure to notify does not equal unlawful supply.

2. Legal basis

3. Expert insights

Insight 1: in New Zealand the scrutiny happens after the market entrance. Most countries run submit-first, enter-later; New Zealand runs enter-first, prove-later. The responsible party lands entirely on the Sponsor (New Zealand sponsor): there is no authority to convince, but the Sponsor must show good reason to believe the device is safe when questioned. The structure is one of deferred burden of proof: the default state is that you may sell, but the default is not immunity.

Insight 2: 45 days determines the form of the dossier, not its necessity. Forty-five days is enough to locate and deliver an existing archive; it is not enough to run a new clinical evaluation or remediate a quality system. What s 38 demands is not a folder awaiting completion but a sealed, numbered, indexed evidence system. GRZAN applies a simple test in verification: could the dossier be retrieved by the local New Zealand Sponsor alone, without help across time zones.

Insight 3: s 38 is not the only provision that demands technical grounds. The Medicines Regulations 1984 has several provisions pointing straight at technical documentation. Reg 4(6): a device described as complying with a particular description must actually comply — a conformity claim becomes a verifiable requirement. Reg 62: a device claimed to work by inducing, concentrating, channelling, generating, countering, shielding or protecting against magnetic, galvanic (direct current), electric, electronic, radiant or vibratory forces or effects must not be sold unless its properties are quantitatively described to the purchaser in writing, in terms of scientifically measurable physical parameters, before or at the time of sale, and the device actually possesses the claimed properties — all but a direct demand for a technical parameter sheet. Reg 25(2) prohibits false or misleading statements in written or pictorial material supplied with the device, pulling instructions and promotion under the same truthfulness constraint.

There is also the classification basis. The first item of the reg 7 declaration requires the Sponsor to declare that the product is a device in the legal sense and correctly classified; Schedule 2 contains 22 rules, and Medsafe states expressly that it does not rule on classifications submitted by companies. The classification must be held by the Sponsor, and the technical foundation rests on the technical documentation.

Insight 4: the liability ladder is steep, and the rungs are not the same order of magnitude. Breach of regs 6, 8, 9 or 10 of SR 2003/325 carries under reg 14 a fine of up to NZ$500; breach of reg 62 of the Medicines Regulations 1984 carries under reg 64 the same ceiling of NZ$500. The ceiling of s 38(8), by contrast, is 6 months imprisonment or a NZ$5,000 fine. The heaviest penalty is reserved for selling after a concrete demand for evidence — the direct consequence of absent technical documentation.

4. Practical recommendations

1. Build the dossier to a questioned standard, not a reviewed standard: take an s 38(2) notice as the assumed scenario, with a 45-day response pack as the deliverable, containing the safety argument, risk management, clinical evidence and the basis of conformity claims.
2. Index overseas documentation locally: TGA, FDA and CE approvals and assessments can serve as raw material for safety evidence, but must be directly citable by the New Zealand Sponsor. The legal status of this material is covered in article 19 of this series.
3. Separate express requirements from practical judgement: the regulations give no list of which products need preparation to what depth; GRZAN normally advises a configuration based on risk classification, invasiveness and market history (a practical estimate).
4. Keep instructions and promotion aligned with the technical evidence: reg 4(6) and reg 25(2) of the 1984 regulations govern what is said; every claim must be supportable by the technical file.
5. Run at least one retrievability drill each year: reg 9 requires the Sponsor to establish procedures for ongoing compliance with regs 5, 6 and 8; fold the drill records in.

5. Verification checklist

• □ A local New Zealand contact designated to receive and answer s 38 notices
• □ Safety evidence dossier deliverable within 45 days, with one internal retrieval drill completed
• □ Risk classification records and technical grounds retained for current products
• □ All claims on the device (labels, instructions, promotional pages) checked against the technical evidence
• □ Claimed functional properties supported by quantitatively described, scientifically measurable parameters (where reg 62 situations arise)
• □ Sponsor confirmed to have established compliance procedures under reg 9
• □ Unique product identifiers for Class III and AIMD devices confirmed as entered in WAND
• □ Responsibility and escalation path defined for the two penalty tiers of reg 14 and s 38(8)

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 WAND entries and sponsor registration, prepares reference-market evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com