New Zealand medical device registration timeline
Source-linked clocksMedsafe (Ministry of Health) (Medsafe) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — WAND notification-based system classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| All devices (WAND notification)(Notification to the Web Assisted Notification of Devices (WAND) database) Regulation 10: notification decided within 30 working days; the notification track applies to all risk classes — there is no regulator pre-market assessment | 30 working days | 1-2 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesNew Zealand Medical Device Registration Process
Step-by-step Medsafe registration process. Total estimated timeline: 1-2 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Medsafe. Appoint a New Zealand Sponsor.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Medsafe including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMedsafe reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
30 working daysIn-depth technical assessment of device safety and performance. Medsafe may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Medsafe issues New Zealand market authorization certificate.
- New Zealand sponsor (local representative) responsible for the WAND notification
- Devices must be sourced from a country with an approved regulatory regime (e.g., EU MDR, FDA TGA-equivalent) or meet alternate-entry rules
- Notification updates within 10 working days of change (reg 8(2))
- No regulator pre-market assessment: market access hinges on the 30-working-day notification