Post-market surveillance
What is required in New Zealand?
New Zealand's post-market surveillance framework is significantly lighter than the EU MDR or Australian TGA frameworks. There is no mandatory:
- Post-market surveillance plan (PMS plan)
- Periodic Safety Update Report (PSUR)
- Post-market clinical follow-up (PMCF) report
- Formal trending report cycle
However, Sponsors are required to:
- Report adverse events to Medsafe when they occur
- Maintain distribution records to enable recall traceability
- Respond to Medsafe requests for safety information
- Cooperate with recalls when required
And by good practice (and through the Medicines Act's general safety obligations), Sponsors should monitor device performance systematically.
Distribution records
Maintaining distribution records is mandatory. The Sponsor must be able to identify, in the event of a recall:
- What devices were supplied, in what quantities
- When they were supplied
- To which customers (hospitals, clinics, distributors, practitioners)
Records should be detailed enough to allow rapid and complete notification of affected parties. There is no prescribed format for distribution records.
Good practice — even if not mandatory
Sponsors of higher-risk devices (Class IIb, III, AIMDs) should consider implementing a proactive PMS program even though not strictly required by NZ regulation. This is because:
- The manufacturer likely has PMS obligations under EU MDR, TGA, or FDA — and NZ data should feed into that global program
- If Medsafe requests safety data, having a structured PMS system makes it much easier to respond
- The Medical Products Bill (upcoming) is likely to introduce formal PMS requirements
A basic PMS program for NZ would include:
- Complaints log
- Adverse event log
- Review of overseas regulatory actions (FDA MDRs, EU EUDAMED, TGA database)
- Periodic summary of post-market data
Comparison with other markets
| Requirement | New Zealand | Australia (TGA) | European Union |
|---|---|---|---|
| PMS plan | Not required | Required | Required |
| PSUR | Not required | Required for some classes | Required |
| PMCF | Not required | For some classes | Required |
| Distribution records | Required | Required | Required |
| Adverse event reporting | Required | Required | Required |
| Trend reporting | Not prescribed | Encouraged | Required |