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Medicines (Database of Medical Devices) Regulations 2003

Overview​

The Medicines (Database of Medical Devices) Regulations 2003 (commonly called the WAND Regulations) are the secondary legislation that:

  • Establishes the WAND database and the obligation to notify
  • Sets out what information must be entered into WAND
  • Lists devices exempt from notification (Schedule 1)
  • Sets out the 22 device classification rules (Schedule 2)

The Regulations were made under the Medicines Act 1981. They are available in full at legislation.govt.nz.

Structure of the Regulations​

PartContent
Part 1Preliminary — definitions and application
Part 2Obligation to notify — who must notify, within what timeframes, what information to provide
Part 3The database — how WAND is operated and maintained
Schedule 1Exempt devices — devices not required to be notified
Schedule 2Classification rules — the 22 rules for non-IVD devices

Key regulation provisions​

Regulation 5 — Obligation to notify​

Every Sponsor must notify a device to WAND within 30 calendar days of becoming Sponsor. For IVDs listed in Schedule 1, notification is exempt (but voluntary).

Regulation 6 — Information required​

The following must be entered:

  • Risk classification (per Schedule 2)
  • Sponsor's registered office address and contact details (NZ)
  • Manufacturer's registered office address and contact details
  • GMDN product description

Regulation 7 — Updates​

Changes to information in WAND must be notified within 10 working days.

Regulation 8 — Declaration​

The Sponsor must sign a declaration confirming the accuracy of the information and that the device complies with the Medicines Act.

Schedule 1 — Exempt devices​

See Exempt Devices for a full explanation of Schedule 1 categories.

Schedule 2 — The 22 classification rules​

See The 22 Classification Rules for rule-by-rule guidance.