SaMD and digital health
Software as a Medical Device in New Zealand — how Medsafe currently approaches SaMD, AI/ML-based software, classification, and what the Medical Products Bill will change.
TTMRA and Australia
The Trans-Tasman Mutual Recognition Arrangement — how it applies to medical devices, practical implications for NZ-AU market strategy, and its limitations for devices.
Enforcement and compliance
Medsafe's enforcement powers, compliance notices, product seizure, criminal offences under the Medicines Act 1981, and what to expect in a Medsafe investigation.
NZ in the global regulatory landscape
How New Zealand's Medsafe framework sits in the global medical device regulatory landscape — IMDRF membership, comparisons with AU, EU, US, and UK, and multi-market strategy.