New law regulating AI and SaMD in force late 2029 at earliest

NEWS  - eHealthNews editor Rebecca McBeth

A two-year transition period is planned before the new Medical Products Bill takes effect, which will regulate software as a medical device - including artificial intelligence used for therapeutic purposes.

Tim Vines, manager, therapeutics, strategy, policy and legislation, Ministry of Health, told the MTANZ Conference on June 30 that all essential policy decisions have now been made and that drafting instructions are to be issued this year, but the bill will not be introduced to Parliament before the November election.

The Ministry's indicative timeline is to introduce the bill to Parliament in early 2027. It would then go to the Health Committee for a public consultation process of around six months and could be passed by Parliament by the end of 2027.

A two-year transition period is planned before the law comes into force to allow secondary legislation to be developed, for Medsafe to prepare operationally, and for any necessary IT systems to be put in place. 

Vines said that the bill will regulate software that has a therapeutic purpose, including uses of AI.

Things like patient management software, e-prescribing systems, and AI note-taking scribes are not intended to be regulated as medical devices. 

However, if software moves beyond note-taking into suggesting diagnosis or treatment options, it would be considered to have a therapeutic purpose and would likely be captured under the new regulatory framework.

Vines told the audience that AI is an emerging field and that ongoing discussions with the sector will be needed to determine how New Zealand balances support for innovation against patient safety considerations. 

He said the new bill also extends the regulation of clinical trials to medical devices, a change from the current framework under the Medicines Act, and that this will need to reflect the differences between medicine trials and the typical product development cycles for medical devices.

Image: Tim Vines, manager, therapeutics, strategy, policy and legislation, Ministry of Health speaking at MTANZ Conference 2026

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