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Lifecycle of a medical device in New Zealand

Unlike markets with mandatory pre-market approval, New Zealand's regulatory lifecycle is primarily post-market-focused. However, there are still clear obligations at each stage.

Stage 1 — Pre-supply preparation​

Before a device is supplied in New Zealand, the manufacturer and Sponsor must:

  1. Confirm device status — Is the product a medical device under the Medicines Act definition? Is it exempt from WAND?
  2. Classify the device — Determine the correct class (I, IIa, IIb, III, or AIMD for non-IVDs; 1–4 for IVDs) using the Schedule 2 rules
  3. Obtain GMDN code — A Global Medical Device Nomenclature code is required for WAND notification
  4. Gather conformity evidence — CE certificate, TGA registration, FDA clearance, or equivalent technical documentation
  5. Appoint a NZ Sponsor — if the manufacturer has no NZ presence
  6. Prepare labelling — Ensure labels and IFU meet GHTF/SG1/N43:2005 requirements

Stage 2 — WAND notification​

Once a Sponsor takes responsibility for the device:

  • Notify WAND within 30 calendar days of becoming Sponsor
  • Enter risk classification, GMDN code, manufacturer details, and sponsor details
  • Sign the statutory declaration
  • Receive WAND confirmation

Notification is not approval — Medsafe does not assess the submission. Supply can begin once the notification is complete.

Stage 3 — Ongoing compliance while on the market​

Once the device is being supplied in New Zealand, the Sponsor must:

  • Monitor device performance — complaints, adverse event signals, overseas regulatory actions
  • Report adverse events to Medsafe when required
  • Update WAND within 10 days of any changes to device details, sponsor details, or manufacturer details
  • Maintain distribution records to enable traceability in a recall
  • Keep technical documentation current — available on request from Medsafe

Stage 4 — Changes and variations​

When a device changes — in design, materials, software, labelling, manufacturer, or intended use — the Sponsor must:

  • Assess whether the change is significant enough to affect the device's risk classification or WAND entry
  • Update WAND within 10 days of significant changes
  • Review and update technical documentation
  • Notify Medsafe if the change relates to a safety issue

Stage 5 — Adverse events and FSCAs​

If a safety issue arises:

  1. Assess reportability — does the event meet Medsafe's reporting thresholds?
  2. Report to Medsafe — within the required timeframe (typically 10 working days for serious events)
  3. Assess whether an FSCA is needed — Field Safety Corrective Actions include recalls, safety alerts, and modified instructions
  4. Issue a Field Safety Notice — communicate corrective action to affected customers
  5. Update WAND — mark affected device entries if they are being recalled

Stage 6 — Retirement or discontinuation​

When a device is withdrawn from the NZ market:

  • Update WAND — mark the device as no longer supplied (or obsolete if sponsorship is transferring)
  • Notify distributors and customers if supply is stopping
  • Retain records — distribution and technical records must be kept for a minimum period even after discontinuation

Visual summary​

Pre-supply                Market entry              On market               End of life
─────────────────────────────────────────────────────────────────────────────────────
Classify device     →     WAND notification   →     Monitor safety   →      Remove WAND entry
Gather evidence     →     Sponsor in place    →     Report events    →      Retain records
Appoint Sponsor     →     Supply begins       →     Update WAND      →      Notify customers
Prepare labelling                                   Manage FSCAs