Regulation 7 Declaration: Three Undertakings That Shift Liability to the Sponsor

Regulatory information verified as of October 29, 2026.

1. Key takeaways

Regulation 7 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) sets out the declaration the Sponsor (New Zealand sponsor) must make as part of the notification act under regulation 6. After verifying the official text word by word, GRZAN confirms the formal declaration items of reg 7 are three: (a), (b) and (c) — the product, or products of that kind, is a device in the legal sense and correctly classified under the regulations; the Sponsor recommends the product only for its intended purpose; and the information provided under reg 6(a) is accurate and complete.

This declaration is a rare put-it-in-writing-and-bear-the-liability document in the New Zealand system. The entire WAND (Web Assisted Notification of Devices) notification requires no technical documentation submitted to Medsafe for review; the regulator does not share the classification judgement and does not verify the information’s truth. Reg 7 is the linchpin of this after-the-fact liability structure: at signature, responsibility for three things converges from dispersed to self-borne.

The signatory matters: reg 6(b) allows the declaration by the Sponsor or an employee. Layered on ss 79 and 80 of the Medicines Act 1981, the consequences cease to be a matter for the signing employee alone.

One calibration: Medsafe’s WAND home page says devices must be notified to WAND to be lawfully supplied, but SR 2003/325 sets no provision prohibiting sale without notification. The coercive force lies in the 30 working day notification duty of reg 6 and the 10 working day correction duty of reg 8, breach carrying under reg 14 a fine of up to NZ$500; notification occurs after arrival; and the 9 exempt categories of Schedule 1 may be lawfully supplied without notification. Failure to notify does not equal unlawful supply.

2. Legal basis

3. Expert insights

Insight 1: item (a) locks classification liability onto the Sponsor. Regulation 7(a) requires a declaration that the product is a medical device and correctly classified under the regulations — not neutral wording. It demands from the Sponsor two levels of judgement: product qualification under the device definition in s 3A of the Medicines Act 1981, and risk classification. The classification rules sit in Schedule 2, 22 in number, covering 5 risk classes: Class I, IIa, IIb, III and AIMD; reg 13 adds that where multiple rules apply the highest class prevails, and software takes the class of the device it drives. Medsafe has stated expressly that it does not rule on classifications submitted by companies — the designers knew Sponsors might lack experience and still made them sign and bear it.

Insight 2: item (b) binds the Sponsor’s own recommending conduct, not clinical use. The wording of reg 7(b): the device will only be recommended by the sponsor for use for its intended purpose. The verb is recommended, the subject the sponsor. It does not ask the Sponsor to guarantee clinicians’ conduct or attribute off-label use to it; it binds the Sponsor’s own recommendation, promotion and supply within the intended purpose. Linked provisions: reg 10 of the Medicines Regulations 1984 (device advertisements must state an accurate description, intended use, precautions and contraindications), reg 11 (further requirements for advertisements to health professionals) and reg 7 (advertisements must not claim official approval).

Insight 3: item (c) forms a continuous chain with regs 8 and 9. Regulation 7(c) declares the information accurate and complete — a statement with a timestamp, accurate when made, not necessarily forever after. Reg 8 picks up the baton: when information in the database record is no longer accurate or complete (a change of manufacturer or Sponsor name, a lapsed certification), the Sponsor must notify the correction within 10 working days. Reg 9 adds another link: the Sponsor must establish procedures ensuring ongoing compliance with regs 5, 6 and 8. Together the three show that signing is not a one-off act but a standing state requiring permanent procedures.

Insight 4: the penalty chain — reg 14, s 79 and s 80 stacked three deep. The first layer is reg 14: a Sponsor who breaches any of regs 6, 8, 9 or 10 commits an offence; on conviction the fine is up to NZ$500. Reg 7 itself is not in that list — it is absorbed through reg 6(b): reg 6 requires both delivery of the information and a reg 7-compliant declaration, and a defective declaration means reg 6 is unfulfilled. The second layer is s 79 of the Medicines Act 1981: where an agent or employee commits an offence, the principal (employer) is equally liable, with a defence of not knowing and taking all reasonable steps to prevent it; and when a body corporate is convicted, every director and every person concerned in its management is likewise guilty where the act occurred with their authorisation, permission or consent, or where they knew and failed to take reasonable steps to prevent it. The third layer is s 80 strict liability: in a prosecution for selling a medicine or device in breach of the Act or regulations, the prosecution need not prove intent; the defendant may run a no-intent-plus-reasonable-steps defence, but must serve written notice on the prosecutor within 7 days of the summons being served, stating the intention to rely on the defence and listing the steps relied on; steps not notified may not be led in evidence without leave of the court.

Beyond that sits s 38(8): selling after an s 38(2) notice without timely evidence carries up to 6 months imprisonment or a fine not exceeding NZ$5,000 — outside the reg 7 chain, but the heavier tier the same Sponsor may trigger on the same products.

4. Practical recommendations

1. Turn the declaration into three verifiable determinations, not boilerplate: the item (a) record should include the device definition basis (s 3A, s 4 of the Medicines Act 1981) and the classification trail (the specific Schedule 2 rule numbers); GRZAN normally archives both records together with the declaration text.
2. Confirm the reg 9 procedure is working before signing: an organisation that cannot continuously produce accurate information cannot make the item (c) declaration. GRZAN recommends an information change trigger list as the concrete form of the reg 9 procedure.
3. Limit signing authority and put it in writing: reg 6(b) allows an employee to sign, so define internally which roles may sign and what must be verified before signature.
4. Pre-build an action template for the s 80 seven-day window: once a summons arrives, a written notice listing the reasonable steps must reach the prosecutor within 7 days — uncompiled records cannot be enumerated then.
5. Build a 10 working day change response mechanism: bring manufacturer and Sponsor names, contact details, certification status and GMDN changes into an automatic trigger list.

5. Verification checklist

• □ Confirmed reg 7 contains the three items (a), (b), (c), with evidence against each
• □ Device definition basis retained (s 3A, s 4)
• □ Risk classification record retained, citing the Schedule 2 rule numbers used
• □ Intended use defined in writing, with promotional material confirmed not to exceed it
• □ Notified information checked to match the actual manufacturer and Sponsor details
• □ Information maintenance procedure running under reg 9
• □ 10 working day correction trigger set for information changes
• □ Signing authority for the reg 6(b) declaration restricted in writing
• □ Internal briefing done on s 79 principal liability and the s 80 7-day defence notice
• □ Avoided wording implying WAND entry amounts to official endorsement (reg 10, ceiling NZ$500)

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