Regulation 14 Offences and Penalties for New Zealand Device Sponsors

1. Key takeaways

Regulatory information verified as of 29 October 2026. The full text of reg 14 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) is a single sentence: a sponsor who contravenes any of regulations 6, 8, 9, or 10 commits an offence and is punishable on conviction by a fine not exceeding $500. The provision was amended on 1 July 2013 by s 413 of the Criminal Procedure Act 2011 (2011 No 81), the amendment concerning the fine wording.

NZ$500 is often cited to show New Zealand device regulation is lenient. After verifying the entire penalty framework, GRZAN’s judgement is the opposite: reg 14 reaches only four procedural duties — first notification (reg 6), information correction (reg 8), procedure building (reg 9), prohibited representations (reg 10) — punishing failures to put information into the database truthfully and promptly. The penalties tied to product safety sit in s 38 of the Medicines Act 1981: selling a device after a safety evidence notice, before the requirement is met or a satisfactory notice of safety is received, is punishable by up to 6 months imprisonment or a fine not exceeding NZ$5,000 — the only device provision carrying imprisonment.

Treating reg 14’s NZ$500 as the ceiling of compliance risk is a serious misjudgement. Its real weight comes from the conviction record itself, the extension of liability to directors and managers under s 79, and the administrative and commercial consequences that follow.

• Reg 14 punishes breaches of reg 6, reg 8, reg 9 and reg 10 with a fine not exceeding NZ$500.
• Amended on 1 July 2013 by Criminal Procedure Act 2011 s 413 (fine wording).
• The heaviest device penalty is s 38(8): up to 6 months imprisonment or NZ$5,000.
• The expensive part is the conviction, not the fine amount.
• s 79 extends liability to directors and managers; s 80 makes sale offences strict liability.

2. Legal basis

The instruments relevant to reg 14 offences are set out below.

3. Expert insights

Insight 1: the legislator deliberately grades information duties separately from safety duties. The reg 14 cap is NZ$500; the s 38(8) cap is NZ$5,000 plus 6 months imprisonment — an order of magnitude apart, with a personal sanction attached. The gap is deliberate tiering: the former governs informational duties whose breach harms database accuracy; the latter concerns placing unsafe products in users’ hands. Once understood, it is clear why finishing notification never equals finishing compliance.

Insight 2: what is truly expensive is the conviction, not the fine. A conviction leaves a criminal record, not a parking ticket. For a company supplying public hospitals, purchasing authorities routinely require disclosure of convictions in supplier vetting. For individual directors, s 79(3) applies where a body corporate is convicted of an offence against the Act or regulations made under it — wording covering secondary legislation, so a reg 14 conviction falls squarely within scope. Where a body corporate is convicted, every director and every person involved in management commits the same offence if the conduct is proved to have been authorised, permitted or consented to by them, or to have occurred with their knowledge and without reasonable steps to prevent it. Section 79(2) offers a defence of not knowing and taking all reasonable steps to prevent, but the text limits it to proceedings under s 79(1); when directors and managers are pursued under s 79(3), that defence is unavailable. GRZAN notes that exclusion from hospital supplier lists over compliance records is a practical commercial consequence (practical estimate), often far exceeding NZ$500.

Insight 3: strict liability under s 80 means we did not intend it is no answer. In prosecutions for selling medicines or devices in breach of the Act or regulations, intent need not be proved. A defendant relying on the no-intent plus all-reasonable-steps defence must serve written notice on the prosecutor within 7 days of service of the summons, or the defence is inadmissible. The evidential burden shifts to the company: daily record-keeping, written procedures and responsible-person sign-off determine whether the defence can stand.

Insight 4: the administrative tools outside reg 14 carry more deterrent weight. Reg 50 of the Medicines Regulations 1984 empowers the Director-General to issue withdrawal orders under (a) and (b); disposal or destruction of devices proceeds under (d) — the disposal order in (c) covers medicines and related products only. Paragraphs (c) and (d) cannot be triggered on their own: they presuppose a withdrawal order under (a) or (b). Non-compliance is punishable under reg 64(1)(b) by a fine not exceeding NZ$500, but the commercial consequences of the order itself — delisting, channel removal, recall costs — sit outside the fine. In addition, s 63 confers inspection powers and s 66 allows import, purchase, manufacture and sale records to be required; refusal is itself an offence.

4. Practical recommendations

• Do not rank compliance priorities by fine amounts. GRZAN’s risk assessments order by consequence type: safety evidence under s 38 first, withdrawal risk under reg 50 second; the four reg 14 duties carry low fines but, with high trigger frequency and strict liability, equally need routine management.
• Turn the procedures required by reg 9 into presentable written documents. Reg 9 is the only purely procedural reg 14 duty and the most easily ignored; GRZAN drafts it as a management procedure covering responsible persons, deadline triggers, change identification and evidence retention, presentable on demand during inspection or prosecution.
• Build the record-keeping that supports the s 80 defence. Responsible-person signatures, timestamps, external correspondence and training records should be archived; write the 7-day notice deadline into procedures and designate the first responder after a summons is received.
• Turn prohibited representations into a red-line list for marketing. Reg 10 and reg 7 of the 1984 Regulations jointly close off official endorsement wording; GRZAN bans phrases such as approved by Medsafe, certified by the New Zealand Ministry of Health and holds a New Zealand registration certificate, supplying compliant alternatives.
• Brief the board on director liability. Section 79 extends liability to every director and manager; report the New Zealand device duty list and its status to the board at least annually — a governance act and evidence of reasonable steps.

5. Verification checklist

• □ Confirmed reg 14 covers reg 6, reg 8, reg 9 and reg 10
• □ Recorded that reg 14 was amended on 1 July 2013 by Criminal Procedure Act 2011 s 413
• □ Confirmed NZ$500 is the reg 14 cap, not the global cap of compliance risk
• □ Confirmed s 38(8), up to 6 months imprisonment or NZ$5,000, is the highest device penalty tier
• □ Compliance procedures required by reg 9 are documented and presentable on demand
• □ Daily record-keeping supporting the s 80 defence is in place, including the 7-day notice deadline
• □ Marketing material screened for prohibited representations under reg 10 and reg 7 of the 1984 Regulations
• □ Directors and managers are aware of personal liability under s 79
• □ Delisting and recall contingency plans evaluated for a reg 50 scenario

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