WAND overview
What the WAND database is, why it exists, and how it underpins New Zealand's medical device market entry system under Medsafe.
Exempt devices — Schedule 1
Medical devices that are exempt from mandatory WAND notification under Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003.
WAND submission process
Step-by-step guide to notifying a medical device to the WAND database — information required, the GMDN code, the 30-day timeline, and the statutory declaration.
Conformity evidence
What safety and performance evidence Medsafe may request, which overseas approvals are accepted, and how to structure your technical documentation for the NZ market.
Changing sponsors
How to transfer WAND entries from one New Zealand Sponsor to another — the process, obligations of outgoing and incoming sponsors, and key timelines.