Thirty Working Days: The Statutory Notification Timeline and Conflicting Official Wordings

Regulatory information verified as of October 29, 2026.

1. Key takeaways

The wording of regulation 6 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) is: the Sponsor (New Zealand sponsor) must complete the delivery of information and the declaration within 30 working days after becoming the sponsor of the device. The statutory standard is regulation 6’s 30 working days.

Three wordings must be laid side by side, with different weight. Wording one (statutory, controlling): the text of reg 6 of SR 2003/325 says 30 working days, running from becoming the sponsor of the device. Wording two: Medsafe’s Regulatory Requirements for Sponsors page (Revised: 10 May 2011) also says 30 working days, running from the date the device first arrives in New Zealand. Wording three: Medsafe’s WAND home page (Revised: 1 July 2014) says 30 calendar days — inconsistent with both the regulation and Medsafe’s own other page, a wording defect on the Medsafe side.

GRZAN’s conclusion has two layers. First, the statutory standard: external commitments and compliance judgements use the 30 working days of the regulation; the 30 calendar days on Medsafe’s home page does not change the obligation. Second, internal management: because another Medsafe page starts the clock at first arrival in New Zealand, GRZAN advises an internal countdown of 30 calendar days from first arrival (a practical estimate — experienced judgement, not an official requirement), covering the wording uncertainty with the strictest rhythm.

One inference must be expressly forbidden: regulation 6 cannot be read backwards to mean that failure to notify is unlawful supply. In New Zealand, notification happens after the device arrives; the system contains no pre-supply notification gate, and devices falling within the nine Schedule 1 exemptions never need to notify at all. Regulation 6 governs the timeliness of notification, not the legality of supply.

Breaching regulation 6 lands in reg 14: a Sponsor who breaches any of regs 6, 8, 9 or 10 commits an offence punishable on conviction by a fine not exceeding NZ$500. The fine is modest, but s 80 of the Medicines Act 1981 provides that the prosecution need not prove intent; the defendant must run a no-intent-plus-reasonable-steps defence, serving written notice on the prosecutor within 7 days of the summons.

2. Legal basis

Official sources: https://www.legislation.govt.nz/regulation/public/2003/0325/latest/ ; https://www.medsafe.govt.nz/regulatory/DevicesNew/3WAND.asp ; https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp

3. Expert insights

Insight 1: the trigger is a factual status, not a contractual event. The reg 3 definition of Sponsor is a set of factual acts: exporting or arranging export from New Zealand, importing or arranging import into it, or manufacturing or arranging manufacture there for supply. The most common error is treating the contract, purchase order or payment date as the trigger; all three may fall earlier or later than the actual arrangement, and once they diverge from the facts the internal clock shifts.

Insight 2: even Medsafe’s own two pages disagree on the trigger. Becoming the Sponsor and first arrival are rarely the same day. If the identity has already arisen during sea transit because of the import arrangement, a first-arrival clock starts later; the reverse can happen where a company manufactures locally before handing over for distribution. Medsafe’s Regulatory Requirements for Sponsors page uses 30 working days with the first-arrival explanation, while its WAND home page says 30 calendar days — one agency, two wordings. Log both dates; do not rely on a single page.

Insight 3: working days versus calendar days differ by roughly two weeks. The statutory term is working days; the WAND home page uses calendar days. 30 working days, excluding weekends, spans about six weeks in practice (a practical estimate; the regulation does not define working days, and no official text sets out the public-holiday exclusion rules). Managing the timeline on the intuition of 30 calendar days overruns the working-day allowance the regulation permits.

Insight 4: the deadline obligations do not stop at one. Reg 6 is the first-notification deadline; reg 8 is the correction deadline — 10 working days from the date the information ceases to be accurate or complete. The duties exist independently; completing the first notification does not end the deadline regime, and name changes or lapsed certifications restart the clock.

Insight 5: exempt devices never enter the clock at all. If a device falls within one of the nine Schedule 1 exemptions, the duties of regs 5 and 6 do not apply and the timeline question disappears. Exempt devices remain subject to the other requirements of the Medicines Act 1981 and its regulations, and Medsafe requires post-market actions taken for safety reasons on them (recalls, corrections, alerts, safety alerts and the like) to be notified.

Insight 6: one backward inference must be prohibited. Regulation 6 cannot be read as failure-to-notify-equals-illegal-supply. The sequence is arrival first, notification second; notification is not a precondition to lawful supply. Reading reg 6 as no-notification-no-selling drags in the misreading that WAND is a market authorisation — the misconception Medsafe has repeatedly corrected. Reg 6 governs the timeliness of notification once a person becomes the Sponsor; the liability is the offence risk under reg 14, not the validity of supply.

4. Practical recommendations

• External statements use the statutory standard: notification within 30 working days of becoming the Sponsor, never the 30 calendar days of Medsafe’s WAND home page.
• Set the internal countdown at arrival in New Zealand plus 30 calendar days, warning line 7 calendar days early. This strictest-rhythm arrangement is a practical estimate and does not alter the 30 working day standard applied externally.
• Record two dates for every SKU — when the Sponsor identity arose and first arrival in New Zealand — with supporting documents (import papers, bills of lading, arrival records). With both on file, questions under any wording are answerable.
• In holiday-dense periods (Christmas and New Year), do not schedule against an ideal working-day count; the exclusion rules are not stated in any official text, so strictest-reading margin is safer.
• Keep a reg 8 trigger list covering manufacturer and Sponsor name changes, lapsed certifications and GMDN updates; once triggered, count down the 10 working days.
• If a deadline is missed, do not backfill silently: record the cause and remediation under reg 9 and complete the information proactively. The s 80 all-reasonable-steps defence needs written evidence, served within 7 days of the summons.

5. Verification checklist

• □ Sponsor identification basis (which limb of reg 3) clear and the date recorded
• □ First arrival date recorded, with documents retained
• □ External wording unified: notification within 30 working days of becoming the Sponsor
• □ Internal countdown set on the strictest rhythm (30 calendar days from first arrival), known to be a practical estimate
• □ Medsafe’s two pages inconsistent (30 calendar days / 30 working days from first arrival) — internal position unified
• □ The forbidden inference — failure to notify equals unlawful supply — excluded from messaging
• □ The reg 6 first-notification deadline and the reg 8 10 working day correction deadline distinguished
• □ A reg 9 procedure in place, with records and remediation
• □ The reg 14 penalty ceiling of NZ$500 and the s 80 strict liability rule known internally
• □ Confirmed whether the device falls within a Schedule 1 exemption (if exempt, reg 6 never applies)
• □ Margin reserved for public holidays affecting working days (practical estimate)

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