Recent regulatory changes
This page covers significant regulatory changes affecting medical devices in New Zealand. For the latest updates, always check medsafe.govt.nz and health.govt.nz directly.
2025
Cabinet decisions on SaMD and innovation (July 2025)
Cabinet agreed that the Medical Products Bill will regulate Software as a Medical Device (SaMD), including AI used for a therapeutic purpose. The SaMD definition will be internationally aligned (IMDRF-based). General clinical software and general-use AI will be excluded. Flexible approval pathways for novel and innovative products were also agreed. See Medical Products Bill.
Export-only products (2024)
Cabinet confirmed that export-only devices will not require New Zealand regulatory approval under the forthcoming Medical Products Bill — eliminating a concern raised by industry during earlier TPA development.
2024
Therapeutic Products Act 2023 repealed
The TPA — which was passed in 2023 and would have introduced a modern pre-market approval system — was repealed in early 2024 following a change of government. The Medicines Act 1981 continues to apply.
Medical Products Bill announced (September 2024)
The Government confirmed it would develop a new Medical Products Bill to replace the Medicines Act 1981. Medsafe was confirmed as the continuing regulator. See Medical Products Bill.
Classification divergence from AU and EU
The Australian TGA continued to align its classification rules with the EU MDR (2017/745), creating growing discrepancies between AU/EU classification and NZ classification for some device types. NZ sponsors should not assume AU or EU class automatically applies in NZ.
Ongoing developments to monitor
- Medical Products Bill — drafting and Parliamentary introduction (expected late 2025)
- IMDRF guidance on SaMD and AI — Medsafe alignment
- TTMRA operation post-Medical Products Bill enactment