Medical Products Bill
Background
The Medical Products Bill is New Zealand's planned replacement for the Medicines Act 1981. Developing a modern regulatory framework for medicines and medical devices has been a long-running project in New Zealand. The most recent attempt — the Therapeutic Products Act 2023 (TPA) — was passed by Parliament in 2023 but repealed in 2024 following a change of government.
The current Government announced in September 2024 that it would develop a new Medical Products Bill, with Medsafe confirmed as the ongoing regulator.
Why the Medicines Act 1981 needs replacing
The Medicines Act 1981:
- Was written before modern medical technology existed
- Has no framework for software as a medical device or AI-based diagnostics
- Does not provide formal pre-market approval pathways for devices
- Does not align with modern international frameworks (EU MDR, IMDRF)
- Has limited tools for clinical trial oversight for devices
What the Medical Products Bill will change
Based on Cabinet decisions made through 2024 and 2025, the Bill is expected to include:
Pre-market requirements
- Formal approval pathways for medical devices (replacing the WAND notification-only model)
- Risk-proportionate approval — lower-risk devices will have lighter requirements
- Export-only devices will not require NZ approval (confirmed by Cabinet in 2024)
Software as a Medical Device
- The Bill will explicitly regulate SaMD (confirmed by Cabinet in July 2025)
- The SaMD definition will be internationally aligned (IMDRF-based)
- General clinical software and general-use AI will be excluded
- AI used for therapeutic purposes will be included
Clinical trials
- Risk-based clinical trial approvals
- Low-risk trials may only need to be notified to Medsafe
- High-risk trials will require Medsafe approval and ethics review
- All trials will continue to require ethics approval
Regulatory structure
- An independent statutory officer (rather than Medsafe being entirely within the Ministry of Health)
- The officer appointed by the Director-General of Health
- Cost-recovery model continued
Timeline
| Date | Event |
|---|---|
| 2023 | Therapeutic Products Act 2023 passed |
| 2024 | TPA repealed following change of government |
| September 2024 | Government announces Medical Products Bill |
| November 2024 | Public webinar on the planned Bill |
| 2025 | Ongoing Cabinet decisions on key policy settings |
| Late 2025 (estimated) | Draft Bill expected to be introduced |
| Unknown | Enactment — during current parliamentary term |
See the Medical Products Bill Tracker for current status.
Once the Bill is enacted, the transition to the new framework will require significant preparation — new approval applications, updated QMS procedures, possible UDI obligations. Sponsors and manufacturers supplying the NZ market should monitor the Bill's progress closely and begin assessing the likely impact on their product portfolios.