Definition of a Medical Device under the Medicines Act 1981

1. Key takeaways

The sole statutory gateway for whether a product is a medical device in New Zealand is s 3A of the Medicines Act 1981 (1981 No 118), inserted by s 6 of the Medicines Amendment Act 2013 (2013 No 141), in force from 1 July 2014. GRZAN’s verification confirms a four-part structure: (a) the core definition; (b) materials brought within scope; (c) articles used together with a device and regulation-declared kinds; (d) articles regulations declare not to be devices.

The s 3A core definition restates as one operational sentence: an instrument, apparatus, appliance or other article intended for human use whose principal intended action is not achieved by pharmacological, immunological or metabolic means, though such means may assist it. The trailing clause is often overlooked, yet it decides drug-device combinations, devices with biological materials and drug-eluting products: with s 4 (replaced by s 7 of 2013 No 141 from 1 July 2014), a product is a device only when it has a therapeutic purpose and its mode of action falls within the s 3A mechanism limits.

One missed rule: s 105(i) lets the Governor-General make regulations specifying what articles are or are not devices; paragraphs (c) and (d) are open-ended outlets populated by secondary legislation. Schedule 1(a) of the 2003 Regulations adds that a device that is also a medicine within s 3(1) of the Act is exempt (except where Schedule 2 cl 13(2) applies) — the statutory combination-product boundary.

Characterisation does not change the system: once a product is a device, what follows is not approval but notification to WAND; Medsafe performs no technical review and issues no certificate.

2. Legal basis

The verified sources below anchor the definition.

Note: the Gazette publication date of that notice is stated inconsistently across two Medsafe pages (18 December 2003 in one, 24 December 2003 in the other), so only the signature and commencement dates are recorded.

3. Expert insights

Insight 1: The dividing test is how the principal intended action is achieved, not the product form. Many classify by physical form, but s 3A(a) supplies a mechanism test. Fix the judging question: is the claimed principal intended action achieved mainly by physical, mechanical or structural means? If so, the product remains a device even where pharmacologically active ingredients assist (catheters with antimicrobial coatings, fillers containing lidocaine), provided the principal action is non-pharmacological. Where the principal action depends on pharmacological processes of a drug in the body, the product belongs on the medicines track. This is a continuum judgement, not a binary selection; borderline conclusions must be reasoned in writing and archived.

Insight 2: Software and accessories enter device scope through s 3A(c). Paragraph (c) covers articles used with a device so it can be used as the manufacturer intends, pulling in software, consumables, dedicated chargers and calibration items. The implementing rules sit in reg 13 of the 2003 Regulations, applied in statutory order; wrong order gives wrong results. Reg 13(2) classifies by intended purpose first; 13(3) classifies combination devices separately; 13(4) classifies accessories separately; 13(5) classifies software with the device it drives; 13(6) classifies devices not dedicated to a specific site by their most critical specified purpose; 13(7) takes the highest classification where several rules apply. The two most common GRZAN errors: omitting bundled software when notifying the host device, opening a reg 5 gap that cascades into reg 8; and reversing 13(3) and 13(4), entering a separately-classifiable accessory at the host’s level.

Insight 3: The manufacturer’s intention is a legal fact, not marketing language. Reg 7(b) requires the Sponsor to declare that the product is recommended only by intended purpose. Intended purpose is fixed by the manufacturer’s documented intention, and advertising material, usage imagery and sales scripts can all become evidence against it. Reg 25(2) of the Medicines Regulations 1984 adds that material supplied or displayed with a device must contain no false or misleading statements about its nature, fitness for purpose or effects. Promotional wording and statutory characterisation must share one source; once they diverge, the truthfulness of the Sponsor’s declaration is challenged.

Insight 4: Characterisation immediately opens three branch judgements. Characterisation is not the end. First, check the 9 exemption classes in Schedule 1: custom-made patient devices, practitioner-made devices for a particular patient, customs transit, IVDs used only within a particular laboratory, laboratory-developed tests (LDTs), personal importation for own use, importation for clinical trials, Gazette-declared exempt classes. Second, confirm Sponsor (New Zealand sponsor) identity against reg 3. Third, risk classification and GMDN selection; reversing the order causes substantial rework. At step three, note one inconsistency between the regulation text and Medsafe’s annotation: Class AIMD is separately provided by rule 20 of Schedule 2, whose text states “An active implantable medical device is classified as Class AIMD”, with subclauses making an implantable accessory to an AIMD Class III and an active device used to control, monitor or directly influence AIMD performance likewise Class III; rules 10 to 13 cover active devices, therapeutic, diagnostic, and drug administration or removal, and AIMD is not among them. Medsafe’s grouping of rules 10–13 under the AIMD heading is inaccurate; classification follows the regulation text.

4. Practical recommendations

• Write the characterisation conclusion as a one-page document. GRZAN issues a New Zealand product characterisation statement for every SKU: product description, mechanism of the principal intended action, the s 4 therapeutic purpose category, and conclusion citations (specific paragraphs of s 3A and s 4). It is retrievable for regulatory enquiries, distributor challenges and classification disputes.
• Institute a claims-versus-characterisation consistency review. Final review of external claims sits with regulatory staff, not marketing. GRZAN copies the s 3A(a) mechanism wording into the copy template, so every new functional claim passes a mechanism check.
• Run dual-track assessments early for combination and borderline products. For drug-device combinations and devices with biological materials, evaluate both tracks during development; the wrong pathway must not surface just before launch.
• Place exemption checks at procurement and order stage. Several Schedule 1 exemptions (clinical trial importation, customs transit, LDTs) depend on use scenarios, not the product itself. Make the exemption question a pre-import gate, answered and filed by the Sponsor at order confirmation.
• Confirm characterisation and classification with the manufacturer in writing. Schedule 2 contains 22 classification rules and Medsafe declines to rule on classifications. Written manufacturer confirmation at this stage settles the sourcing of several downstream fields at once.

5. Verification checklist

• □ The mechanism of the product’s principal intended action compared clause by clause against s 3A(a)
• □ Whether the product falls within s 3A(b) materials or s 3A(c) accompanying articles confirmed
• □ Regulations under s 105(i) declaring the product to be or not be a device checked
• □ The s 4 therapeutic purpose category confirmed
• □ Applicability of the 9 Schedule 1 exemption classes excluded or confirmed
• □ Combination products assessed for whether they are also medicines within s 3(1)
• □ Sponsor (New Zealand sponsor) identity matches the reg 3 definition
• □ Written manufacturer confirmation of characterisation and classification obtained
• □ Characterisation statement and external claim text compared for consistency

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 Medsafe sponsor obligations and WAND entry requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com