Technical File Readiness under Section 38 of the Medicines Act 1981

Regulatory information verified as of 29 October 2026

1. Key takeaways

There is no mandatory approval requirement for devices before supply in New Zealand, and the technical file is not a statutory submission either — SR 2003/325 requires WAND entry of fields such as the risk classification, the manufacturer and Sponsor (New Zealand sponsor) names and addresses, contact details and the GMDN product description, and contains no technical documentation at all.

But s 38 of the Medicines Act 1981 sets a reverse switch: where the Director-General has reason to believe a device may be unsafe, he or she may give written notice to an importer or manufacturer in New Zealand requiring proof of its safety; the importer or manufacturer must submit evidence of safety within 45 days of receiving the notice (or a longer period the Director-General allows); if the Director-General is not satisfied, a further notice may be issued calling for more evidence. Selling the device while the evidence requirement is unmet, or before receiving the Director-General’s satisfaction notice, carries under s 38(8) imprisonment not exceeding 6 months or a fine not exceeding NZ$5,000.

Section 38(5) adds a key qualification: the fact that the Director-General has not exercised this power does not constitute a guarantee of the safety of the device. The system moves the safety argument that most jurisdictions complete pre-market into a post-market, passively triggered event; the value of the technical file therefore lies not in being submitted and reviewed, but in being producible at any time.

2. Legal basis

The table below lists the regulatory and official sources verified for this article and the provisions relied on.

3. Expert insights

Insight 1: the systemic gap — the burden of proof is pushed to the post-market phase.

Most jurisdictions place the safety argument before market entry; New Zealand places it after market entry as a passively triggered event. Section 38(6) further makes clear that the Director-General may exercise this power repeatedly against several importers or manufacturers of devices of the same kind, and is not limited by having exercised it or not exercised it against one importer. This means a company cannot infer future safety from never having been asked before.

Insight 2: 45 days is a hard deadline, but the clock starts in the regulator’s hands.

The 45 days run from receipt of the notice, and when the notice is issued is entirely unpredictable. In a cross-border supply chain, the time taken for documents to move from the overseas manufacturer is included within those 45 days, and the time actually available for assembly is far less than the headline figure. The technical file must already be bound into volumes before the notice arrives; this is the only viable countermeasure (practical estimate).

Insight 3: how recommends becomes an enforceable obligation.

The wording of GRTPNZ (Ed 2.0, May 2024) §4.1.2 is that Medsafe recommends devices comply with the requirements of applicable ISO standards, which is a recommendation and not mandatory; §4.1.3 recommends supplying instructions in English. But the Medicines Regulations 1984, reg 4(6), provides that where a device is described as conforming to a particular description, it must genuinely conform; and s 40 also contains provisions on compliance with standards. Once a company claims conformity with an ISO standard in its labelling, instructions or promotional material, that claim converts from a recommendation into an enforceable obligation, with reg 25 catching any pictorial or written instructions that are false or misleading. This is the practical mechanism by which New Zealand turns a recommendation into a binding requirement.

Insight 4: the file is a risk-hedging asset, not a submission.

The technical file is never reviewed and produces no approval outcome. Its sole function is to enable a coherent safety argument to be assembled within 45 days when an s 38 notice arrives. The dossier should be designed to self-prove, be producible on demand and trace to the specific model — not to be as thick as possible.

4. Practical recommendations

• GRZAN recommends designing the dossier backwards from the 45-day countdown: finished documents deliverable on the day the notice arrives, manufacturer correspondence to be completed within 15 days, and test reports requiring external bodies — managed as three tiers with a named owner on each.
• GRZAN requires the dossier to be built per model and decoupled from the WAND grouped entry records — grouping reduces the number of entries, not the granularity of evidence, and an s 38 notice is directed at a specific device.
• The dossier should cover the following categories (practical estimate, not a statutory list): device description and intended purpose; GMDN code and classification conclusion records (IVDs use the IVD classification code and do not apply the 22 rules of Schedule 2); the list of applicable standards and conformity evidence; the risk management report; biocompatibility and sterilisation validation records (for voluntarily notified IVDs there is no need to enter information on animal-derived materials or formulations); design verification and validation records; clinical evidence or the clinical evaluation report; labelling and English instructions for use; model and batch lists; manufacturer qualifications and overseas approval certificates; distribution records; complaint and adverse event records; the internal procedures established by the Sponsor under reg 9; and a copy of the reg 7 declaration.
• Supply English instructions for use as recommended by GRTPNZ §4.1.3; electronic instructions may be provided, but the Sponsor must be able to supply a paper version when a user requests one (practical estimate).
• Re-check every conformity claim in the labelling, instructions and promotional material: any claim of conformity with a standard must have corresponding conformity evidence in the dossier, to avoid triggering reg 4(6) and reg 25.
• Run an annual mock retrieval drill: draw a model at random, require delivery of the complete dossier within a set time, and keep the drill record.

5. Verification checklist

• □ It has been confirmed that the technical file is not a statutory submission for WAND, and the dossier has not been filed as an application.
• □ The 45-day evidence deadline of s 38(3) and the penalty of s 38(8) (up to 6 months imprisonment or up to NZ$5,000) have been confirmed.
• □ The dossier has been built per model and decoupled from the WAND grouped entry records.
• □ The three-tier delivery mechanism (immediately deliverable, completed within 15 days, issued externally) is in place with named owners.
• □ The list of applicable standards and the conformity evidence correspond one to one.
• □ Conformity claims in the labelling, instructions and promotional material have been re-checked, with evidence complete.
• □ English instructions for use have been supplied, and the availability of paper versions has been verified.
• □ The reg 9 procedure documents and a copy of the reg 7 declaration are in the dossier.
• □ The annual mock retrieval drill has been run and the record retained.

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