Medical Products Bill tracker
The Medical Products Bill will replace the Medicines Act 1981 with a modern, risk-proportionate framework for medicines and medical devices. This page tracks its progress.
Source
Information on this page is drawn from Ministry of Health publications at health.govt.nz and Cabinet papers released publicly.
Status overview
| Stage | Status |
|---|---|
| Decision to develop the Bill | ✅ Complete — September 2024 |
| Key policy settings agreed | ✅ Ongoing — multiple Cabinet rounds |
| SaMD and innovation provisions agreed | ✅ Complete — July 2025 |
| Draft Bill publicly released | 🔄 Expected late 2025 |
| Parliamentary introduction | 🔄 Expected during current term |
| Select Committee consideration | ⏳ Not yet |
| Enactment | ⏳ Not yet |
| Transition period / commencement | ⏳ Not yet |
Key confirmed policy decisions
| Decision | Date | Detail |
|---|---|---|
| Medsafe continues as regulator | Sep 2024 | |
| Independent statutory officer | Sep 2024 | Appointed by Director-General of Health |
| Cost-recovery model retained | Sep 2024 | With new levy-setting power |
| Export-only products excluded | 2024 | No NZ approval needed for export-only |
| SaMD regulated | Jul 2025 | IMDRF-aligned definition |
| General clinical software excluded | Jul 2025 | Not a medical device |
| AI for therapeutic purposes included | Jul 2025 | Regulated as SaMD |
| Risk-based clinical trials | Jul 2025 | Low-risk notify only; high-risk require approval |
| All trials need ethics approval | Jul 2025 | Unchanged from current |
What to watch
- Pre-market approval pathways for devices — the specific routes and requirements have not yet been confirmed in detail
- Transition arrangements — how existing WAND notifications will transition to any new approval framework
- UDI requirements — whether NZ will introduce UDI under the new Bill
- PSUR and PMS requirements — whether formal periodic reporting will be introduced
- IVD regulation — whether IVDs will continue to be exempt or will require formal approval
How to stay informed
- Ministry of Health Bill page
- Medsafe What's New
- New Zealand Parliament — for Bill status once introduced