Medical Device Labelling and Advertising Requirements in New Zealand

1. Key takeaways

Regulatory information verified as of 29 October 2026. New Zealand’s device labelling requirement sits in one provision, reg 12(4) of the Medicines Regulations 1984 (SR 1984/143): No person shall sell any medical device that does not bear the name of the manufacturer of the medical device or the name of the manufacturer’s distributor in New Zealand. It is the only substantive device-labelling requirement in the 1984 Regulations; the reg 12(5) exemption covers medicines only.

On penalties: the reg 64(1)(a) and (c) offence lists include neither reg 12 nor regs 4, 10, 17, 18 and 25, so breaching the device labelling, advertising and misleading representation duties produces no direct criminal penalty under that instrument. Do not invent an enforcement detour through reg 50: 50(1)(b) targets non-conformity with claimed specifications and (a) presupposes a Ministerial s 37 notice — neither fits a missing label. Only reg 62 and reg 50 (up to NZ$500) carry device penalties. Reg 62 covers claims that a device works by inducing, concentrating, channelling or producing magnetic, galvanic, electric, electronic, radiation or vibration forces or effects, or counteracting, shielding or protecting against them, with a written quantitative description to the purchaser and actual possession of those attributes — not a blanket provision for all electronic devices; breaches are offences under reg 64(1)(c). Labelling form: reg 17 requires prominent English, strong contrast, clarity and durability; reg 18(5) sets a 1.5 millimetre letter-height floor, reg 18(6) a 0.75 millimetre floor for small containers.

• Reg 12(4) is the sole device labelling requirement: manufacturer or New Zealand distributor name.
• Reg 12(5) exemption applies to medicines only.
• Only reg 62 and reg 50 are punishable on the device side, each capped at NZ$500.
• Letter height: 1.5 mm (reg 18(5)); 0.75 mm minimum for small containers (reg 18(6)).

2. Legal basis

The statutory basis for labelling and advertising of notified devices is set out below.

3. Expert insights

Insight 1: the only statutory labelling provision has no direct penalty. Reg 12(4) is a plainly worded sale prohibition, yet neither reg 64 offence list names it. The orders fall into two groups: withdrawal orders under (a) and (b) ((b) targeting devices not conforming with their claimed specifications; (a) presupposing a current Ministerial notice, with only s 37 available on the device side (s 35 concerns medicines only)), and disposal and destruction under (c) and (d), limited to what has been withdrawn under (a) or (b) and unable to self-trigger; (c) reaches only medicines, while devices fall under (d). Conclusion: reg 12(4) carries no direct criminal penalty and no alternative conviction route.

Consequences enter through the inspection power. Section 63(2) gives eleven limbs: (d)(e) inspection of articles and manufacturing or packaging processes have no threshold; seizure of labels or advertising ((j)) needs only a breach or non-conformity. Locked out are seizure of devices ((i)) and photography ((k)), which require reasonable belief an offence has been committed; breaching reg 12(4) is not an offence, so both are unavailable — a limited conclusion, not proof Medsafe is powerless. Criminal consequences come from s 66(3): refusal to provide records is an offence. More deterrent is s 98: the Director-General may publicly state a position on any device or related advertising, protected by qualified privilege — Medsafe’s leverage is often public naming. Note that s 79 extends liability but creates no offence: provisions outside the reg 64 lists yield no offence, so it cannot apply.

Insight 2: s 56 defines a label as an advertisement, so the two rulebooks connect. The s 56 definition of advertisement includes trade circulars, labels and trade journal advertisements; labels must not breach reg 25 or fall within the 7 prohibited matters in s 57. Medsafe states New Zealand has no statutory IFU requirement; once supplied, the IFU falls under reg 25: no comment contradicting, qualifying or varying label content, and no false or misleading statements, brands, pictures or marks. The s 56 publish definition carries catch-all limb (e) — bringing to the notice of the New Zealand public in any other manner — covering websites, e-commerce pages, social media and Chinese-language promotion aimed at New Zealand.

Insight 3: the Schedule 1 disease list is advertising’s hardest red line. Under s 58, medical advertising must not directly or by implication claim to prevent, mitigate or cure the Schedule 1 Part 1 diseases or conditions, including cancer, diabetes, arthritis, cataract, heart disease and infertility; nor claim panacea effects, absolute efficacy, or use or endorsement by practitioners, nurses or pharmacists.

Insight 4: s 59 is a duty, exemption and penalty trio. Section 59(1) requires medical advertisements to state the advertiser’s true name and address (a body corporate may substitute its registered office, s 59(2)); breach is punishable under s 59(5) by a fine not exceeding NZ$1,000. The duty is not unconditional: s 59(4)(a) disapplies s 59 where name and address disclosure regulations already apply, and s 59(4)(b) excludes exempted advertisers. Section 60 exempts advertisements distributed only to the s 58(1)(c)(ii) professionals or published in periodicals principally intended for them — professional journals qualify; internet pages and exhibition materials do not.

4. Practical recommendations

• Move the reg 12(4) naming requirement to packaging design: the first packaging specification must bear the manufacturer’s or New Zealand distributor’s name; relabelling after arrival costs far more.
• Validate size and durability at the proofing stage: the 1.5 millimetre floor in reg 18(5), the 0.75 millimetre floor in reg 18(6) for small containers, and the reg 17 form requirements.
• Screen copy against the s 58 Schedule 1 list: build the Part 1 disease names into a search-term list, compare website and social copy, and rewrite on any hit.
• Differentiate audiences to satisfy reg 10 and reg 11(4). Public-facing advertisements must, where applicable, state an accurate description, the purpose, precautions and contraindications; those directed at medical, dental, pharmacy and allied professionals must also state distribution restrictions, methods of use, effectiveness and limitations. Reg 11 was substantially amended on 1 August 2011 (SR 2011/245 reg 7).
• Ban official approval wording outright. Reg 7 of the 1984 Regulations and reg 10 of the 2003 Regulations jointly close off official endorsement phrases; marketing and distributor channels share one prohibited-word list.

5. Verification checklist

• □ Label bears the manufacturer’s or New Zealand distributor’s name (reg 12(4)); reg 12(5) exemption medicines only
• □ Letter height meets reg 18(5) at ≥1.5 mm, or reg 18(6) at ≥0.75 mm for small containers
• □ Accompanying graphics and instructions screened for reg 25 contradictions and false or misleading content
• □ External material contains no claim that breaching reg 12(4) is fined NZ$500, and no invented reg 50 detour
• □ Confirmed regs 4(6), 10, 11(4), 12, 17, 18 and 25 are outside the reg 64 lists; only reg 62 and reg 50 carry penalties on the device side
• □ Copy searched against the s 58 Schedule 1 list; advertiser’s true name and address stated (s 59, up to NZ$1,000)
• □ Public-facing advertisements include reg 10 items; professional-facing include reg 11(4) items

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 coordinates New Zealand sponsor arrangements, import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com