New Zealand: an under-explored SaMD frontier
Last week Australia, this week New Zealand. No travelling involved (still in Zurich) — just sharing under-explored regulatory opportunities for digital health, one Trans-Tasman neighbour at a time.
A framework built for hardware, stretched to cover software
New Zealand's medical device regulation sits under the Medicines Act 1981 — yes, that old — administered by Medsafe. It was built for physical devices and was never designed with software in mind, which shows in how thin the software-specific detail is once you go looking for it.
Software as a Medical Device that meets New Zealand's definition of a medical device must be notified to the WAND database (Web Assisted Notification of Devices), a simple listing system managed by Medsafe that collects product information but does not assess safety or performance before market entry. Notification is free, there's no licence or approval issued, and it must happen within 30 days of becoming the device's New Zealand sponsor.
No pre-market approval — with three sharp exceptions
Pre-market approval is not required, unless the product:
touches life-threatening or irreversible conditions
controls conception
is embedded into a physical device
For standalone, low-risk SaMD, that means a path to market with especially low friction. Notify WAND, hold your technical documentation and safety evidence in case Medsafe asks for it, and you're supplying legally. There's no technical review, no registration certificate, and no fee. For now.
The clock is ticking — but the runway is longer than you'd think
In 2026, New Zealand's Ministry of Health is expected to introduce a new Medical Products Bill to Parliament, which will finally bring SaMD — including AI used for a therapeutic purpose — under proper regulatory control, replacing the Medicines Act. This isn't New Zealand's first attempt: the Therapeutic Products Act was actually passed into law in 2023, then repealed in December 2024 after industry pushback that it risked overregulating low-risk products. The Medical Products Bill is the more risk-proportionate successor.
Current government guidance points to the Bill coming into effect around 2030, with a transition period on top of that — recent reporting suggests the new SaMD and AI rules won't actually bind until late 2029 at the earliest. Even once it lands, it's expected to preserve real competitive advantages relative to more restrictive regimes:
a relatively narrow "medical purpose" definition and an easier self-certification path for low-risk SaMD
international reliance — fast-tracking devices that already carry approval from trusted overseas regulators such as FDA or under the EU's CE marking regime
recognition of TGA (Australian) approvals, consistent with the long-standing Trans-Tasman regulatory relationship between the two countries
Geographic bundling: Australia first, New Zealand as the natural extension
This is where the two markets click together strategically. Australia gives you a well-structured, modern, and accessible regulatory framework — a solid stepping stone toward other global jurisdictions, as I've written about separately. New Zealand is a straightforward extension of that same effort: a smaller market, a lighter compliance lift today, and — until the Medical Products Bill fully lands around 2030 — an even easier, still-compliant option for a digital health company entering international markets for the first time.
The two regulators' history of mutual recognition means the strategic logic compounds rather than just adds up: build your regulatory file once, with Australia and New Zealand both in mind, and you're covering two markets for close to the incremental cost of one.
What this means in practice
If you're weighing New Zealand as part of an early international footprint, it's worth treating the current low-friction window as exactly that — a window, not a permanent feature. Building your safety and performance evidence to a standard that would satisfy Medsafe if asked, rather than to the bare minimum WAND requires, will save you the retrofit when the Medical Products Bill's transition period eventually arrives. The regulatory bar is low today; it won't stay that way indefinitely, and the companies that treat New Zealand's current framework as a genuine compliance obligation — not just a formality — will be the ones with the least work to do when it changes.
References
Medsafe, Explanation of the WAND Database and The WAND Database, New Zealand Ministry of Health
New Zealand Ministry of Health, Regulating medicines, medical devices and natural health products — Medical Products Bill policy documents
Beehive.govt.nz, Therapeutic Products Act repeal bill passed, and related Medical Products Bill announcements
Health Informatics New Zealand (HINZ), New law regulating AI and SaMD in force late 2029 at earliest
Buddle Findlay, New Medical Products Bill prescribed to treat ailing Therapeutic Products Act — on international reliance and risk-proportionate approval pathways
Methodology note: This article is based on my original LinkedIn post (link), reflecting my professional experience advising companies on medical device and SaMD strategy in New Zealand and Australia. AI assisted in elaborating the topic into a broader article by integrating background research and regulatory references on New Zealand's current WAND notification system and the Medical Products Bill. All analysis and regulatory perspectives are my own, and all content has been reviewed by me for accuracy.
