Therapeutic Products Act 2023 — New Legislative Framework for Medical Devices
The Therapeutic Products Act 2023 (TPA) establishes New Zealand's new unified framework for regulating therapeutic products — including medical devices — replacing the patchwork of legislation previously governing devices. Under the TPA, medical devices are regulated on a risk-based classification model (Class I–IV), and manufacturers or sponsors must hold or rely on a valid conformity assessment from a recognised body (e.g. TGA, EU NB, Health Canada) rather than meeting a separate New Zealand-specific standard.
Key changes from the prior regime include:
- Mandatory conformity assessment evidence (replacing the voluntary WAND notification system for higher-risk devices).
- Post-market surveillance obligations aligned with IMDRF guidance.
- Strengthened adverse event reporting requirements.
- A transitional period allowing devices currently on the market to continue supply while sponsors achieve full compliance.
📅 Effective / published: 2023 (implementation phased; commencement date subject to regulations)
Manufacturers and sponsors supplying devices in New Zealand should assess which conformity assessment evidence they hold and whether it will satisfy TPA requirements. Devices currently notified through WAND should be reviewed against the new classification and conformity assessment pathways. Monitor the Medsafe website and the Ministry of Health's TPA implementation updates for commencement dates and transitional provisions.
View official source (Medsafe — TPA) ↗