Prohibited statements: reg 10 and New Zealand device advertising claims

1. Key takeaways

Reg 10 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) forbids a manufacturer or Sponsor (New Zealand sponsor) publishing any statement directly or by implication stating that database entry means the Director-General or the Ministry of Health recognises the product as safe or fit for purpose. Breach is an offence fined up to NZ$500 under reg 14.

The prohibition binds manufacturers and Sponsors, not only New Zealand entities; the regulated conduct is “publishing”, unlimited by channel. Layered on top, s 56 of the Medicines Act 1981 (1981 No 118) includes labels and trade journals in advertisement, and paragraph (e) of publish covers internet advertising — every sentence on a website, e-commerce page or package sits under the same rules.

Reg 7 of the 1984 Regulations (SR 1984/143) likewise prohibits official-approval claims, parallel with reg 10 and s 57. Medsafe warned on 22 July 2025 that “advertisements claiming Medsafe approval or bearing the Medsafe logo are scams” — with no device pre-market approval system, “approved by Medsafe” is factually false and strikes reg 10, reg 7 and s 57 simultaneously.

2. Legal basis

The three instruments and their chains:

3. Expert insights

Insight 1: reg 10 targets misalignment, not falsehood. Most advertising provisions strike false statements; reg 10 strikes the misstatement of “notified” as “recognised”. Even with a genuine notification record, wording leaving an impression of official endorsement triggers reg 10 — the test is whether the statement implies recognition by the Director-General or the Ministry of Health.

Insight 2: the three provisions run on different penalty chains. The reg 10 chain is closed: reg 14 of SR 2003/325 expressly lists reg 10 as an offence, fined up to NZ$500. Reg 7 of the 1984 Regulations is not on the reg 64 offence list — no independent penalty, and approval claims usually land through s 57 or s 61 of the Act.

Insight 3: a low fine is not a low risk. The reg 14 cap is NZ$500; the real exposure is brand and channel. The compulsory layer: s 63 lets officers enter premises, open packages, copy records, seize devices or advertising and labelling materials, and photograph — thresholds differ; device seizure (i) and photographing (k) require reasonable belief of an offence against the Act or regulations; label or advertising seizure (j) requires only breach or non-compliance, no offence. s 66 empowers records demands; s 66(3) makes refusal an offence. The non-compulsory but highly deterrent layer: s 98, protected by qualified privilege — Medsafe can name companies without defamation liability. The real leverage is often not the fine but public naming, with commercial damage exceeding NZ$500 by orders of magnitude.

s 59 requires advertisements to carry the advertiser’s true name and address, fined up to NZ$1,000 — above the reg 14 NZ$500 — the advertising-side provision with teeth. s 61 misleading branding is the sole trigger for a s 86 court recall order (withdrawal only on a s 61 conviction); it dates from the 1969 amendment, is rarely used and lacks public case law — not a routine recall tool; the routine instrument is the reg 50 recall order.

Liability allocation turns on the nature of s 79: s 79(1) and s 79(3) both contain “or against any regulations made under this Act”, so secondary-legislation offences are in scope — reg 14 and SR 1984/143 convictions both qualify. But s 79 only extends who is liable; it creates no standalone offence — an underlying offence must first exist before liability reaches the principal (s 79(1)) and directors and managers (s 79(3)). For provisions on the reg 64 offence list (reg 62) or in the Act (s 38(8), s 61), the offence triggers s 79 once established; for regs 10, 12(4), 17, 18 and 25, not on the list, the breach alone is no offence and s 79 cannot apply. The s 79(2) defence applies only to proceedings under s 79(1); directors under s 79(3) must instead prove the act was without their authorisation, permission or consent, without their knowledge, or that they took all reasonable steps to stop it. Subsection (3) reads “if it is proved”, so the burden lies on the prosecution. Under s 80, the prosecution need not prove mens rea; the defence must prove absence of fault and all reasonable steps.

4. Practical recommendations

• Build a prohibited-words list, screen every item before release. GRZAN recommends red-lining: Medsafe approval / Ministry of Health certification / official recognition / WAND registration certificate.
• Use the replacements below.

• Write review and takedown rights over promotional wording into the Sponsor agreement: New Zealand-bound manufacturer materials require Sponsor confirmation, with takedown on demand.
• Retain the evidence chain against s 63 and s 66: review records producible on demand — s 66(3) makes refusal an offence.

5. Verification checklist

• □ All materials screened against the prohibited-words list, no “Medsafe approved / certified” wording remaining
• □ Advertisements state accurate description, purpose and contraindications (reg 10), with the advertiser’s true name and address (s 59)
• □ No Medsafe or Ministry marks or names used for endorsement, and no s 61 misleading branding
• □ No cure claims for Schedule 1 Part 1 diseases (cancer, diabetes, arthritis, cataract, heart disease, infertility, leukaemia)
• □ Material review and training records producible on demand (s 63, s 66 — s 66(3) refusal an offence), supporting the s 80 defence

Regulatory information verified as of 29 October 2026.

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 adverse event reporting and recall coordination with Medsafe, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com