Medicines Amendment Act 2025: why the verification pathway excludes devices

1. Key takeaways

The Medicines Amendment Act 2025 (2025 No 66) received royal assent on 18 November 2025 and came into force on 19 November 2025 (s 2). It amends the Medicines Act 1981 (1981 No 118) by inserting ss 22A–22F, a “consent by verification” pathway for medicines — the industry’s “Rule of Two”: full marketing authorisations from 2 or more recognised authorities.

This pathway does not apply to medical devices. Paragraph 10 of briefing H2026079100 (Regulatory settings for medical devices), sent to Minister Simeon Brown in February 2026, states: *“The Verification Pathway only applies to medicines and not to medical devices.”* GRZAN has verified the text — the most direct official boundary statement yet.

Device proposals that write in the “verification pathway”, “30-day fast approval” or “two overseas approvals and you are in New Zealand” misattach the provisions. Between 2024 and 2026 the medicines side saw three amendments to the Medicines Regulations 1984 (SR 1984/143); the device side saw none.

2. Legal basis

The table lists the pathway instruments and boundary-fixing sources.

3. Expert insights

Insight 1: the exclusion of devices is not an oversight — it follows from the structure of the system. The pathway lets a medicine that would otherwise need full review rely on overseas approvals. Devices in New Zealand have no pre-market review at all — paragraph 6 of the February 2026 briefing confirms: “there is no pre-market assessment or approval requirement for medical devices supplied in New Zealand. Suppliers are not required to demonstrate approval by any overseas regulator.”

Insight 2: one set of Regulations — three amendments for medicines, none for devices.

• SL 2025/256 (made 17 November 2025, Gazette notice 20 November 2025, in force 19 December 2025): inserted reg 44BA and amended reg 64(1)(a).
• SL 2025/302 (made 1 December 2025, Gazette notice 4 December 2025): confined reg 44BA(1) to “puberty suppression in a child or adolescent”, the explanatory note conceding that 2025/256 *“was inadvertent”*.
• SL 2025/318: transitional arrangements for vaccine administration and supply.
• On 17 December 2025, per health.govt.nz, the High Court declared the Crown must not enforce the regulations pending judicial review, but *“the regulations have not been set aside and are in force from 19 December 2025”*.

The medicines side completed three amendments within one month (one correcting its own error); the device side’s last substantive change since 2004 remains 7 August 2020 (Public Service Act 2020, s 135).

The medicines side also has s 17 (manufacturing, packing and wholesale licensing), s 46(3)(a) (continuing GMP evidence), s 46(4) (refusal, revocation, suspension) and s 41 (mandatory adverse effects reporting, fine up to NZ$1,000). The device side has none of these — Medsafe’s audit capability covers medicines only, s 41 does not apply to devices, and device adverse event reporting is voluntary. The contrast is a complete tier gap in the institutional structure.

Insight 3: the 7-authority list still has indirect value for devices — but of a different nature. The 7 authorities in Gazette 2026-sl772 legally serve the medicines pathway only, yet have two practical uses: under s 38, where the Director-General has reasonable grounds to believe a device may be unsafe, approvals from these authorities are the most direct evidence for the 45-day response; and hospital procurement scores overseas approvals. Both are evidential and commercial value, not statutory market access.

Insight 4: the medicines-side design points to the possible direction of a future device regime. The “2 overseas regulators” threshold reflects recognising overseas approvals instead of duplicate domestic review. If a future device regime moves to risk-tiered approval, the same fulcrum is likely — but as of the verification date the Medical Products Bill has not been introduced into Parliament.

4. Practical recommendations

• Fix a boundary statement in every proposal template. Add to the front page of every New Zealand device deliverable: the consent by verification pathway established by the Medicines Amendment Act 2025 (2025 No 66) applies to medicines only, not to medical devices; devices supplied in New Zealand face no pre-market approval requirement. This blocks importing “two overseas approvals” or “30-day fast approval” into device proposals.
• Never present the 7-authority list as a device access list. Its legal effect stops at medicines. Use it only as a value reference for the approval portfolio and a source of s 38 evidence material — never as “device approval authorities recognised by New Zealand”.
• Organise overseas approvals to the s 38 evidence standard. Section 38(3) allows 45 days for the evidence, and s 38(8) penalises selling before compliance with up to 6 months imprisonment or NZ$5,000. Pre-assemble TGA, FDA, EMA and MHRA approvals, classification rationales and clinical evaluation summaries into a retrievable evidence pack.
• Maintain verification discipline against claims that the regime is about to change. The only test is whether a corresponding Bill number appears on legislation.govt.nz. As of 29 October 2026 there are no new device-side Bills; Parliament adjourned on 24 September 2026, dissolved on 1 October 2026, with the election on 7 November 2026 — this term’s legislative window has closed.
• Track the judicial progress of the three medicines-side instruments. SL 2025/256 and SL 2025/302 are subject to a High Court judicial review declaration; although unrelated to devices, this affects how the Regulations text is understood, and reg 44BA citations must use the version as amended by SL 2025/302.

5. Verification checklist

• □ 2025 No 66, assent 18 November 2025 and commencement 19 November 2025 are recorded
• □ ss 22A–22F establish medicines consent by verification, threshold: full marketing authorisations from 2 or more recognised regulators
• □ The Consent by Verification Rules 2026 — made 20 May 2026, in force 3 July 2026, 10 working day assessment, 30 working day decision, 4-year maximum term — are recorded
• □ The Gazette 2026-sl772 (11 February 2026) 7-authority list is recorded, marked not applicable to devices
• □ No proposal contains “devices can use the verification pathway”, “two overseas approvals suffice” or “30-day fast approval”
• □ Paragraph 10 of H2026079100 is cited as the boundary basis
• □ SL 2025/256 / 302 / 318 (in force 19 December 2025) and the zero device-side amendments are recorded; the device side has no GMP / licence provisions and s 41 applies to medicines only
• □ Overseas approvals are pre-assembled into a retrievable pack against the s 38 45-day window
• □ Medical Products Bill references are marked “not yet introduced into Parliament as of the verification date”

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