Enforcement and compliance
Medsafe's enforcement approach
Medsafe generally takes a risk-based, proportionate approach to enforcement. Most compliance issues are resolved through engagement — Medsafe will typically contact a Sponsor with concerns before taking formal action. However, where devices pose significant risks or where a Sponsor is unresponsive, Medsafe has significant formal powers.
Medsafe's enforcement powers
Under the Medicines Act 1981, Medsafe can:
Information and inspection
- Enter premises — authorised Medsafe officers can enter any premises where devices are manufactured, stored, or supplied
- Request documents — including WAND records, technical documentation, distribution records, and adverse event logs
- Take samples — for testing or analysis
Market controls
- Direct cessation of supply — require a Sponsor to stop supplying a device
- Require recall — direct a Sponsor to recover devices from the market
- Issue public safety communications — publish warnings about specific devices or Sponsors
- Seize devices — physically remove devices that pose immediate risk
Enforcement notices
- Compliance notices — formal notice requiring corrective action within a specified timeframe
- Infringement notices — on-the-spot financial penalties for specified offences
Prosecution
- Criminal prosecution — for serious offences under the Medicines Act
Key offences
| Offence | Potential consequence |
|---|---|
| Supplying a device without required WAND notification | Fine |
| Making a false or misleading WAND entry | Fine; potential prosecution |
| Supplying a device that breaches the Medicines Act | Fine; potential prosecution |
| Failing to comply with a Medsafe direction | Fine |
| Obstructing a Medsafe inspector | Fine |
What to expect in a Medsafe investigation
If Medsafe contacts you about a compliance concern:
- Take it seriously — respond promptly to all correspondence
- Cooperate — provide the requested information within the timeframe given
- Seek expert advice — engage a regulatory affairs professional or lawyer if the matter is complex
- Document your response — keep records of all communications with Medsafe
Most investigations are resolved without formal enforcement action if the Sponsor cooperates and addresses the issue quickly.
Border controls
Medsafe works with New Zealand Customs to identify devices imported into NZ that may not comply with the Medicines Act. Imported devices can be detained at the border if they appear to be supplied without WAND notification or are suspected of being unsafe.