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
| Part | Content |
|---|---|
| Part 1 | Preliminary — definitions and application |
| Part 2 | Obligation to notify — who must notify, within what timeframes, what information to provide |
| Part 3 | The database — how WAND is operated and maintained |
| Schedule 1 | Exempt devices — devices not required to be notified |
| Schedule 2 | Classification 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.
Expand 'Regulation 7 — Updates' section with: "Changes must be notified to Medsafe within 10 working days. Updates are typically submitted via the WAND portal by logging into the Sponsor account and modifying the relevant entry. If the portal cannot be accessed or the nature of the change is complex, Sponsors should contact Medsafe directly with full details of the device and the change required."