Overseas Approvals in New Zealand: Status, Limits and Evidentiary Value

Regulatory information verified as of October 29, 2026.

1. Key takeaways

Approvals from the TGA, FDA, CE and Health Canada are not a statutory condition of market entry for medical devices in New Zealand. New Zealand has no pre-market approval for devices. Regulation 5 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) lists the information that must be entered in WAND (Web Assisted Notification of Devices), and it is only three items: the risk classification; the names and contact details of the manufacturer and the Sponsor (New Zealand sponsor); and the GMDN code — with Class III and AIMD devices additionally requiring a unique product identifier. Nothing on that list is a foreign approval certificate.

A new variable after 2025: the Medicines Amendment Act 2025 (2025 No 66, effective 19 November 2025) established a verification pathway for medicines, conditional on full marketing authorisation from 2 or more recognised regulatory authorities; the accompanying Gazette notice Recognised Regulatory Authorities (2026-sl772, 11 February 2026) designated 7 authorities — EMA (centralised procedure), Australia’s TGA, Health Canada, the US FDA, the UK MHRA, Singapore’s HSA and Swissmedic; and the Consent by Verification Rules 2026 were made 20 May 2026, effective 3 July 2026. Act, notice and rules form one body, all in the medicines system; none applies to medical devices. Paragraph 10 of the Ministry of Health’s February 2026 briefing Regulatory settings for medical devices states it in terms: the Verification Pathway only applies to medicines and not to medical devices.

On the device side, no mandatory foreign approval requirement has ever existed: CE marking, TGA inclusion, FDA 510(k) or PMA are none of them a condition of entry. GRZAN’s conclusion has two layers: the recognised status of the 7 authorities and their rules serve medicines only, irrelevant to devices; and that does not prevent the same approval from doing real work in two other settings — as safety evidence for an s 38 response, and as a trust asset in procurement and hospital access. One wording needs calibrating: Medsafe’s WAND home page says devices must be notified to WAND to be lawfully supplied, but SR 2003/325 has no provision prohibiting sale without notification; the coercive force lies in the 30 working day duty of reg 6 and the 10 working day duty of reg 8 and their NZ$500 penalty; notification occurs after arrival, and the 9 exempt categories may be lawfully supplied without notification.

2. Legal basis

3. Expert insights

Insight 1: being designated a recognised regulatory authority does not make its device approvals valid in New Zealand. The Gazette notice 2026-sl772 does place the TGA, FDA, Health Canada and others on the recognised list, but the list serves the medicines verification pathway under ss 22A–22F of the Medicines Amendment Act 2025, and the accompanying rules likewise cover medicines only. Medicines and devices sit in two separate regimes and the legal routes do not connect. Chaining together — we hold TGA approval, New Zealand recognises the TGA, therefore device access is unobstructed — is the classic error of applying medicines provisions to devices. Note also the list’s composition: 2026-sl772 designates EMA (centralised procedure), TGA, Health Canada, US FDA, MHRA (UK), HSA (Singapore) and Swissmedic. Japan is not on the list; PMDA approvals cannot claim verification pathway eligibility.

Insight 2: the true statutory use of foreign approvals lies in s 38. Section 38 gives companies a concrete evidentiary scenario: where the Director-General has reason to believe a device may be unsafe, he may give written notice to the importer or manufacturer requiring safety evidence within 45 days. A TGA or FDA approval, a CE certificate and its conformity assessment records are the most persuasive, most readily deliverable evidence within those 45 days. The first real value of a foreign approval in New Zealand is as the core of the 45-day response pack, not a market access credential.

Insight 3: foreign approvals help define intended use — which is exactly what reg 7 demands. Regulation 7(b) of SR 2003/325 requires the Sponsor to declare that it recommends the device only for its intended purpose — the provision under scrutiny when off-label or out-of-scope promotion is challenged. Foreign approval documents usually carry clear indications and use descriptions, strong evidence that the recommendation is not an invented use. Alongside it: reg 10 of the Medicines Regulations 1984 (device advertisements must state an accurate description, intended use, precautions and contraindications) and reg 11 (further requirements for advertisements to health professionals).

Insight 4: three red lines govern claims about foreign approvals. First, reg 7 of the Medicines Regulations 1984 prohibits advertisements from claiming official approval. Second, reg 10 of SR 2003/325 prohibits statements implying that entry in WAND amounts to endorsement of safety or suitability by the Director-General or the Ministry of Health; breach of regs 6, 8, 9 or 10 carries under reg 14 a fine of up to NZ$500. Third, reg 25(2) prohibits false or misleading statements in written or pictorial material supplied with the device. GRZAN adds one caution: regs 4, 10, 12 and 25 are not in the reg 64 offence list of the Medicines Regulations 1984, and no standalone penalty provision for them appears in the current text — so it is unsafe to say flatly that breaching reg 12(4) draws a NZ$500 fine. The rules exist; cite the penalties carefully.

4. Practical recommendations

1. Put foreign approvals in the evidence pack, not the access pack: distinguish statutory access documents from safety evidence material in the compliance plan; GRZAN writes the distinction into a written note in pathway design to prevent later blurring.
2. State the scope of authorisation when citing: name the approving authority, approval type, date and scope, noting the document is not a statutory access licence in New Zealand.
3. Maintain a wording cross-reference table: a prohibited-versus-replacement wording list covering reg 7 (1984), reg 10 (2003) and reg 25 (1984).
4. Check consistency across markets: where approved indications differ across foreign markets, take the narrowest range as the boundary of the Sponsor’s recommendation in New Zealand; GRZAN normally advises an internal reference version on the most conservative indication set (a practical estimate).
5. Track the legislation without pre-empting conclusions: as of 29 October 2026 the Medical Products Bill has not been introduced into Parliament; it is a policy draft with several unconfirmed official timetables, and foreign approval strategy should not be adjusted on that basis.

5. Verification checklist

• □ Confirmed no pre-market approval requirement in New Zealand and foreign approvals are not a condition of entry
• □ Confirmed the 2026-sl772 list serves only the medicines verification pathway, not medical devices
• □ Checked which list authorities the company’s foreign approvals come from (Japan is not on the list)
• □ Foreign approval documents filed into the s 38 safety evidence dossier
• □ Sponsor recommendation boundary in New Zealand defined by the foreign approvals’ indications
• □ All wording implying endorsement by Medsafe or the Ministry of Health scrubbed
• □ Advertising materials verified against regs 7, 10 and 11 of the 1984 regulations
• □ The NZ$500 penalty attached to the correct provisions under reg 10 (2003)
• □ Avoided asserting penalties for provisions not listed in the reg 64 offence list

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