Medsafe
New Zealand - Medsafe
Medicines Act 1981 + WAND notification + therapeutic products reform
Authority
New Zealand Medicines and Medical Devices Safety Authority
Enforced
WAND active; reform Bill repealed Dec 2024; replacement Medical Products Bill planned ~2026
Legal framework
Medicines Act 1981 + WAND database (Therapeutic Products Act 2023 REPEALED Dec 2024; Medical Products Bill planned ~2026 as replacement)
Scope
All medical devices supplied in NZ require WAND notification within 30 days. Cybersecurity addressed via CERT NZ guidance pending new Medical Products Bill.
Pre-market
Notification only at present; full pre-market regime awaits the new Medical Products Bill (planned ~2026) after repeal of the Therapeutic Products Act 2023.
Post-market
Adverse-event reporting to Medsafe; CERT NZ coordination for incidents.
SBOM
RecommendedEncouraged via FDA / TGA alignment for trans-Tasman manufacturers.
Vulnerability disclosure
Encouraged via CERT NZ coordinated disclosure.
Penalty
Withdrawal from WAND, sanctions under incoming Therapeutic Products Act.
Unique requirements
- 01WAND notification within 30 days of supply
- 02NZ Sponsor required
- 03TPA 2023 repealed Dec 2024; awaiting new Medical Products Bill (planned ~2026)
Highlights
- Light-touch regime, reform incoming
- Trans-Tasman alignment with TGA
- FDA / CE / TGA approvals widely accepted
Aligns with
Timeline
2003
Medical Devices Regulations enacted
Jul 2023
Therapeutic Products Act passed (subsequently repealed Dec 2024)
Dec 2024
Therapeutic Products Act 2023 repealed; Medical Products Bill announced as replacement (passage expected ~2026)
Key documents
How to submit in New Zealand
Playbook reviewed · 2026-07-16
Submission route
WAND notification with Medsafe (New Zealand)
New Zealand operates a notification (not pre-market approval) regime. Sponsors bear the burden of ensuring cybersecurity evidence exists and can be produced on request.
Authority portalStep-by-step
Step 01
Appoint local representation
Most jurisdictions require a locally-established entity to hold the registration or act as authorised representative before submission.
Step 02
Reuse FDA or CE package as baseline
Adapt the cybersecurity subsection you already prepared for FDA or CE; regulators here typically accept the structure and ask for local labeling additions.
Step 03
Translate and localise
Local-language technical summary and labeling are usually mandatory; certified translation is safest.
Step 04
Submit + track queries
Respond to clarification rounds promptly; each unanswered question can add 30-90 days to the clock.
Evidence checklist
| Item | Level |
|---|---|
| Cybersecurity documentation (baseline FDA or CE) | Required |
| Local authorised representative agreement | Required |
| Local-language labeling and IFU | Required |
| SBOM | Recommended |
Common Medsafe rejections
No New Zealand sponsor listed on WAND
CommonFix · Appoint an NZ sponsor before lodgement.
Typical timeline
End-to-end window: 1-2 months (notification)
Phase 01
Local rep + dossier prep
2-4 months
Phase 02
Regulatory review
1-2 months (notification)
Phase 03
Approval + market entry
1-3 months
Related markets
Frequently asked about New Zealand
Is SBOM required for medical devices in New Zealand?
Recommended. Encouraged via FDA / TGA alignment for trans-Tasman manufacturers.
What does Medsafe require for pre-market cybersecurity?
Notification only at present; full pre-market regime awaits the new Medical Products Bill (planned ~2026) after repeal of the Therapeutic Products Act 2023.
What are the post-market cybersecurity obligations under Medsafe?
Adverse-event reporting to Medsafe; CERT NZ coordination for incidents.
What is the penalty for non-compliance with Medsafe cybersecurity rules?
Withdrawal from WAND, sanctions under incoming Therapeutic Products Act.
How much of my FDA cybersecurity package is reusable in New Zealand?
Roughly 90% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).