Custom-Made Devices in New Zealand: Two Exemption Channels and Patient Matching

Regulatory information verified as of October 29, 2026.

1. Key takeaways

New Zealand leaves two exemption channels open for custom-made devices, not one. Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) lists 9 categories of exempt device, of which paragraph (b) covers devices manufactured in response to a request from a registered health professional specifying design characteristics and intended for a particular patient, while paragraph (c) covers devices supplied to a practitioner for a particular patient of that practitioner. The requesters differ, the elements differ; mixing them is the root of misuse.

GRZAN’s judgement after verifying the text: (b) is broad in requesters — registered health professional means a health practitioner registered under the Health Practitioners Competence Assurance Act 2003 — but strict in requiring both a request that specifies design characteristics and confinement to a particular patient. (c) does not require specified design characteristics, but its requester is narrowed by s 2(1) of the Medicines Act 1981 to a practitioner — a medical or dental practitioner. One is broad where the other is strict; they complement each other exactly.

Failure most often occurs in patient-matching scenarios: selecting a suitable model from an existing size range — orthopaedic implants in different sizes, intraocular lenses in different powers — where the requester did not specify design characteristics and the product was not made for that one patient. Such devices do not meet the elements of (b) and must still be notified to WAND (Web Assisted Notification of Devices) by the Sponsor (New Zealand sponsor) under reg 6, within 30 working days of becoming the Sponsor; Medsafe’s website also carries a 30 calendar days wording. A batch wrongly treated as exempt is missing exactly this record, and breach of reg 6 is an offence under reg 14 with a fine not exceeding NZ$500. A boundary must also be held: Medsafe’s WAND home page says devices must be notified to WAND to be lawfully supplied, but SR 2003/325 has no prohibition on sale without notification; the coercive force lies in the reg 6 and reg 8 deadline duties and their NZ$500 penalty, notification occurs after arrival, and the 9 exempt categories may be lawfully supplied without notification — the home page sentence cannot be read backwards as failure-to-notify-equals-unlawful-supply.

Exemption, once established, does not waive compliance duties: Medsafe states expressly that exempt devices must still comply with all other requirements of the Medicines Act 1981 and its associated regulations, and that post-market actions taken for safety reasons on them must be communicated to Medsafe under the recall code.

2. Legal basis

3. Expert insights

Insight 1: paragraph (b) is a product of three elements, not a pick of three. The structure of Schedule 1(b): the device must be manufactured in response to a request by a registered health professional that specifies the design characteristics, and intended to be used only in relation to a particular patient — the connector is and, so requester qualification, specified design characteristics and single-patient use are all indispensable. In practice the second element is where claims collapse: verbal or form-based requests usually state only the product name and indication, falling short of specifying the design characteristics. The request document is itself the exemption evidence; an oral account proves nothing.

Insight 2: the requester under (c) is narrower than under (b). Section 2(1) of the Medicines Act 1981 defines practitioner as a medical or dental practitioner — plainly narrower than the registered health professional of (b). Medsafe’s gloss uses the everyday phrase healthcare professional, which does not match the statutory wording; in a boundary dispute the statute prevails, and a request initiated by a nurse, technician, optometrist or other registered health practitioner carries uncertainty under (c). Official guidance language here runs broader than the statute and cannot be relied on in reverse. The working solution is to claim (b) and (c) side by side — the exemption stands if either set of elements is complete — but each has its own requester and evidence format, and they cannot be merged into one document.

Insight 3: patient matching is not custom-making. Custom-making means the product is designed because of a particular patient’s anatomical or physiological parameters; matching means selecting from an existing product line — manufacture driven by patient characteristics versus selection driven by patient characteristics. Schedule 1(b) captures the manufacturing-side element, so only the former qualifies. Marketing an entire scaled product line as custom-exempt means, if challenged, losing the notification records for the whole batch. Classification adds a technical consequence: products not exempt must still be placed in Class I, IIa, IIb, III or AIMD under the 22 rules of Schedule 2, and Medsafe states expressly that it does not rule on classifications submitted by companies. The Sponsor must hold the classification line too, and a failed exemption judgement will also distort item (a) of the reg 7 declaration.

Insight 4: the duties after exemption are not reduced. Section 38 empowers the Director-General to require an importer or manufacturer to provide safety evidence within 45 days, and that power does not disappear because the device is exempt. Reg 12(4) of the Medicines Regulations 1984 requires the manufacturer’s name or that of its New Zealand distributor on the label; reg 4(6) requires a device described as complying with a particular description actually to comply; reg 25 prohibits false or misleading statements in written or pictorial material supplied with the device. Custom-made devices often lack standard instructions for use, making these provisions easier, not harder, to breach.

4. Practical recommendations

1. Turn the request document into archivable exemption evidence: the requester’s name and registration category, a written statement of the specified design characteristics, and an anonymised identifier for the patient — all three present before the claim stands. GRZAN recommends a standard written request template.
2. Split the two product lines, custom and matching, first: mark at quotation and contract stage whether each line runs through Schedule 1(b), (c) or normal notification, rather than reconstructing after the batch ships.
3. Set up a separate post-market contact channel for exempt devices: confirm recalls, corrections, alerts and safety alerts on such devices can trigger notification to Medsafe — its requirements sit on the exemption page, yet companies often have no internal owner.
4. Audit the wording of practitioner and registered health professional across documents: mixed usage in contracts, orders and clinical request forms creates evidentiary ambiguity; GRZAN’s document reviews require the statutory wording consistently.
5. Fix the exemption judgement in a written memorandum: the claim is made by the Sponsor alone, with no Medsafe confirmation step; record the basis and the verifier in a written compliance memorandum (a practical estimate).

5. Verification checklist

• □ Requester’s identity recorded in writing and confirmed as a registered health professional or a practitioner
• □ A written request specifying the design characteristics of the device obtained
• □ The intended use of the device confirmed as confined to a particular patient
• □ Assessed separately on the custom-made and patient-matching routes, not mixed
• □ Written and pictorial material supplied with the device checked against false or misleading statements
• □ Manufacturer’s name or that of its New Zealand distributor shown on the device
• □ An owner assigned for notifying post-market actions on exempt devices to Medsafe
• □ practitioner / registered health professional wording unified across contracts and clinical request forms
• □ A traceable exemption determination procedure established per reg 9

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