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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 before issuing WAND confirmation. Supply can begin once the WAND notification is complete and the Sponsor has confirmed that all conformity evidence is held and ready for inspection.

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

GMDN codes are assigned by the GMDN Agency and typically take 5–10 business days to obtain. A fee may apply depending on the GMDN Agency's current pricing structure. Ensure the code is obtained before submitting WAND notification.