Schedule 1 Exempt Medical Devices: Nine Categories and Their Boundaries

Regulatory information verified as of October 29, 2026.

1. Key takeaways

Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) lists nine categories of exempt medical device. A device in any one of them is not subject to the entry duty in regulation 5 or the notification duty in regulation 6. GRZAN has verified the official text item by item and sets out the nine categories, (a) to (i), with the boundary of each.

Exemption does not mean freedom from obligations. Medsafe states officially that exempt devices are devices that are medical devices under the Medicines Act 1981 but are not required to be notified to the WAND database; they must still comply with all other requirements of the Medicines Act and its associated regulations, and post-market actions taken for safety reasons on them (recalls, product corrections, alerts, safety alerts and similar) must still be notified to Medsafe. This premise covers all nine categories and is the one most often overlooked.

Two categories reach far beyond their literal text: (e) covers only IVDs intended for use in a particular laboratory, while (i) authorises the Director-General to declare exempt categories by Gazette notice — the 2003 IVD exemption notice was made under (i), declaring all diagnostic devices commonly known as IVDs to be exempt. Together they shape the distinctive IVD landscape.

The burden of proving an exemption lies on the Sponsor (New Zealand sponsor). Medsafe does not rule on classifications and does not confirm exemption status case by case; a wrong call means the reg 6 duty has been skipped, landing in the offence provisions of reg 14 with a fine ceiling of NZ$500.

2. Legal basis

Official sources: https://www.legislation.govt.nz/regulation/public/2003/0325/latest/ ; https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

3. Expert insights

Insight 1: the nine categories, one by one.

• (a) Devices that are also medicines: any medical device that is also a medicine within s 3(1) of the Medicines Act 1981, except where Schedule 2 cl 13(2) applies. Medsafe’s gloss: medicines must not be notified to WAND. The boundary turns on the cl 13(2) exception — combination drug-devices cannot simply be assumed exempt.
• (b) Made to the order of a registered health professional specifying design features, for a particular patient: both elements must hold — a request from a registered health professional specifying the design characteristics, and use only in relation to a particular patient.
• (c) Supplied to a practitioner for a particular patient: s 2(1) of the Medicines Act 1981 defines practitioner as a medical or dental practitioner — narrower than registered health professional.
• (d) Imported and held under New Zealand Customs control pending export: goods in transit or transhipment: imported, under New Zealand Customs Service control, awaiting export to another country; leave customs control or divert to local sale and the exemption fails.
• (e) IVDs intended for use only in a particular laboratory: two elements stacked; Medsafe’s gloss places this in the laboratory-developed or in-house testing context.
• (f) Diagnostic devices manufactured by a laboratory for supply to another laboratory: the LDT external supply case. The provision says expressly — whether or not because the owner of the other laboratory purchases the device or for any other reason — that a commercial transfer does not defeat the exemption.
• (g) Imported by a person solely for that person’s own use: a person, solely for their own use, and importation. Bulk import for distribution to multiple users fails the test.
• (h) Imported for use in a clinical trial: a clinical trial and importation. The exemption attaches to the import purpose; disposal after the trial needs separate analysis.
• (i) Declared exempt by Gazette notice by the Director-General: an open-ended paragraph giving the Director-General of Health a standing power to expand the exemptions — the 2003 IVD notice was made under it.

Insight 2: the relationship between (e) and (i) defines the IVD landscape. Paragraph (e) reaches only use within a particular laboratory; paragraph (i) is the open channel. The Exemption Medical Devices (in vitro Diagnostic Devices) Notice (No. 1) 2003, made in December 2003, declared under (i) that all diagnostic devices commonly known as IVDs are exempt, effective from 1 January 2004. The two overlap rather than replace each other, and both must be checked.

Insight 3: Medsafe’s glosses are not word-for-word matches of the text. The Medsafe page summarises (b) and (c) as made to specification for a patient and supplied to healthcare professionals for their particular patients, and places (e) and (f) in the LDT context. GRZAN’s conclusion: the glosses assist understanding, but the assessment must return to the statutory text — especially the specified design characteristics element in (b) and the practitioner scope in (c), where the official summaries visibly diverge from the provisions.

Insight 4: post-market duties survive exemption. Medsafe requires post-market actions taken for safety reasons on exempt devices to be notified. That page (last revised 1 July 2014) still cites procedure names superseded by the New Zealand Medicines and Medical Devices Recall Code, current since 1 December 2015. Follow the current code, not the older page’s wording.

4. Practical recommendations

• GRZAN recommends an exemption determination sheet for every SKU, citing the specific Schedule 1 paragraph and recording element by element how the device satisfies it, with supporting documents: for (b), the registered health professional’s request and design specification; for (d), proof of customs control status; for (h), the trial approval and import purpose documents.
• GRZAN repeatedly encounters over-expansive readings of (c). Practitioner in s 2(1) means a medical or dental practitioner only; supply to nurses, technicians or other registered health professionals does not automatically fall within (c): assess it against (b) or another paragraph first, and if none is met, notify normally.
• Read (g) strictly: the solely-for-own-use exemption does not cover resale, distribution or multi-user institutional use in any form; in cross-border e-commerce, direct-to-consumer parcels must be judged order by order.
• Build a periodic review of exemption status: exemptions often attach to a state of affairs — customs control, a trial in progress, use for a particular patient — and when the state ends, the duty returns. Put (d) and (h) on a quarterly review list.
• Even when exempt, avoid wording implying official endorsement: reg 10 targets claims that database entry amounts to official approval, and exempt devices are not in the database at all, so the risk is higher.

5. Verification checklist

• □ Each of the nine paragraphs (a) to (i) of Schedule 1 checked, and the specific paragraph relied on recorded
• □ For (a), the Schedule 2 cl 13(2) exception checked
• □ For (b), the registered health professional’s request and design specification obtained
• □ For (c), the recipient confirmed as a practitioner under s 2(1) (medical or dental practitioner)
• □ For (d), proof of New Zealand Customs control retained and no diversion to local sale confirmed
• □ For (e), use only within a particular laboratory confirmed
• □ For (f), manufacture by a laboratory and supply to another laboratory confirmed
• □ For (g), import by a person solely for that person’s own use confirmed
• □ For (h), clinical trial documents and import purpose statement retained
• □ Exempt devices confirmed still subject to the Act’s other requirements, with post-market safety actions notified to Medsafe
• □ Recall duties executed under the current New Zealand Medicines and Medical Devices Recall Code (in force since 1 December 2015), not the older page wording

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