Importing Devices for Clinical Trials: The Schedule 1(h) Exemption and Its Limits

Regulatory information verified as of October 29, 2026.

1. Key takeaways

Importing devices for clinical trials is an exempt situation in New Zealand, but the exemption covers only one duty: notification to the medical device database WAND (Web Assisted Notification of Devices). The full text of paragraph (h) of Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) is one short English sentence — any medical device imported for use in a clinical trial. GRZAN confirms the sentence carries three qualifiers that cannot be ignored: imported (entering New Zealand by way of import), for use in (the purpose), and clinical trial (the trial itself).

Medsafe’s position on its Medical Devices Exempt from Notification to WAND page is equally clear: exempt devices must still comply with all other requirements of the Medicines Act 1981 and its associated regulations, and any post-market action taken for safety reasons on an exempt device (recalls, product corrections, alerts, safety alerts and similar) must be communicated to Medsafe under the recall code. Once exempt status arises, the company gains not a regulatory vacuum but a list — notification suspended, everything else unchanged.

The trouble rarely starts during the trial; it starts after the trial ends. Once a device moves from trial use to commercial supply, the importer immediately becomes the Sponsor (New Zealand sponsor) and must, under regulation 6 of SR 2003/325, complete notification and submit the regulation 7 declaration within 30 working days of becoming the Sponsor. Medsafe’s website simultaneously carries a 30 calendar days wording and a statement that the period runs from the date the device first arrives in New Zealand — three wordings in circulation at once.

2. Legal basis

3. Expert insights

Insight 1: what is exempt is the notification duty, not compliance itself. Reading exempt device as unregulated device is the most common misjudgement here. The entire exemption mechanism of SR 2003/325 hangs off reg 5 (information entered in the database) and reg 6 (the information and declaration the Sponsor must provide); the reg 14 offence list targets regs 6, 8, 9 and 10. Schedule 1 closes one door — the database — and every other door of statutory duty stays open. Medsafe nails the boundary: such a device must still comply with all other requirements of the Act and its associated regulations.

One calibration: Medsafe’s WAND home page says that for medical devices to be legally supplied in New Zealand they must be notified to the WAND database, but SR 2003/325 has no provision prohibiting sale without notification. The coercive force sits in the deadline duties: breach of the 30 working day notification duty in reg 6 or the 10 working day correction duty in reg 8 carries, under reg 14, a fine of up to NZ$500. Notification happens after the device reaches New Zealand; it is not a pre-market precondition. The 9 categories of exempt devices in Schedule 1 may be lawfully supplied without any notification. Deriving from this that failure to notify is unlawful supply does not work — clinical trial devices are precisely one of those 9 categories.

Insight 2: the anchor of paragraph (h) is imported; local manufacture is outside it. Schedule 1(h) is limited to devices imported for use in a clinical trial. On its words, a device manufactured in New Zealand and used only in a local clinical trial does not fall within the paragraph. This is the point systematically missed in Chinese-language materials: most companies assume anything used in a clinical trial is exempt without distinguishing how the device entered the country. GRZAN first confirms whether the device crossed the border or was produced locally before deciding whether any exemption can be claimed.

Insight 3: three high-voltage lines run through the trial period itself. The first is s 38 of the Medicines Act 1981: 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 safety evidence within 45 days; selling before the requirement is satisfied carries up to 6 months imprisonment or a fine not exceeding NZ$5,000. The second is reg 12(4) of the Medicines Regulations 1984: no person may sell a device that does not bear the manufacturer’s name or that of the manufacturer’s New Zealand distributor. The third is post-market action notification: exempt devices involved in recalls, corrections, alerts or safety alerts must still be reported to Medsafe. In a trial environment, not one internal process usually stands guard over these three lines.

Insight 4: the post-trial trigger arrives earlier than companies think. The 30 working days of reg 6 run from becoming the Sponsor, and reg 3 defines the Sponsor as the person who imports or arranges the device’s import into New Zealand. Where the same New Zealand importer receives both trial devices and commercial stock, the Sponsor identity may already arise when the first commercial consignment enters the country. Add reg 8’s 10 working day correction duty once information becomes inaccurate, and companies that ramp up production stockpiling while the trial winds down face the two clocks running simultaneously.

4. Practical recommendations

GRZAN typically arranges the compliance actions of the clinical trial stage in this order:

1. Keep a standalone trial device ledger: record by batch the product name, manufacturer, quantity, entry date, using institutions, remaining stock and disposal — the only internal evidence that a batch really was for trial use.
2. Fix the commercialisation date at the protocol stage: do not wait until the last follow-up visit to discuss notification. GRZAN recommends back-scheduling at least 30 calendar days from the expected entry date of the first commercial stockpile as the internal notification deadline (a practical estimate — Medsafe’s wording differs from the statute; take the stricter value).
3. Seal the s 38 evidence pack in advance: assemble the safety evidence into a dossier deliverable immediately upon receiving a notice, not retrieved at the last minute.
4. Set written disposal rules for remaining trial devices: transfer to commercial stock, return to the manufacturer, or destroy — the three routes carry different consequences and must each be recorded.
5. Unify external messaging: trial devices are not in WAND, so claims of notification in New Zealand or Medsafe approval are unfounded; even if notified later, reg 10 prohibits statements implying official endorsement.

5. Verification checklist

• □ Confirmed in writing that the device entered New Zealand by import and the purpose points to a clinical trial
• □ Ruled out local manufacture in New Zealand, which Schedule 1(h) does not cover
• □ Batch ledger for trial devices established, covering entry, use, stock and disposal
• □ Manufacturer’s name or its New Zealand distributor’s shown on the device, per reg 12(4) of the 1984 regulations
• □ s 38 safety evidence dossier available for immediate retrieval
• □ Commercialisation milestone set and the notification deadline back-scheduled on the strictest wording
• □ Post-trial Sponsor entity identified, avoiding an identity vacuum among multiple importers
• □ Internal trigger in place for telling Medsafe of post-market actions on exempt devices
• □ All occurrences of the words approval, registration and certificate scrubbed from trial materials

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