Medsafe (New Zealand)

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority, a business unit of the Ministry of Health. It administers national requirements for medicines and medical devices and performs market-surveillance and compliance functions. For most devices supplied in New Zealand, the central practical requirement is sponsor notification in the Web Assisted Notification of Devices (WAND) database.

Does Medsafe approve medical devices?

Generally, no. Medsafe states that most medical devices do not undergo pre-market approval in New Zealand. A WAND notification records information about a device and sponsor; it is not an approval, certification, endorsement, or confirmation that the device complies. Manufacturers remain responsible for ensuring conformity with New Zealand's legal requirements. Some products and circumstances are subject to different or additional controls.

What is WAND?

WAND is Medsafe's online device-notification database. A New Zealand sponsor must generally notify a device to WAND within 30 calendar days after becoming its sponsor. Medsafe states that it does not charge a fee for WAND notifications. The database supports regulatory oversight, but it is not intended to operate as a public list of Medsafe-approved devices.

Who is the New Zealand medical device sponsor?

The sponsor is a person or organization in New Zealand that exports, imports, or arranges the supply of a medical device in New Zealand. An overseas manufacturer therefore normally needs a qualifying New Zealand sponsor. The sponsor is responsible for WAND notifications and has important local obligations involving records, safety information, cooperation with Medsafe, and corrective action.

What evidence should be maintained?

Although a full pre-market dossier is not routinely submitted for most WAND notifications, the manufacturer and sponsor should hold evidence supporting the device's safety, performance, quality, intended purpose, classification, labeling, and conformity assessment. Medsafe can request information and may investigate compliance. A notification should accurately identify the manufacturer, sponsor, and device family or configuration.

What happens after a WAND notification?

The sponsor and manufacturer must keep device and contact information current, operate complaint and vigilance processes, report relevant adverse events, and coordinate recalls or corrective action when needed. Changes to the commercial arrangement should be planned so that sponsor and notification responsibilities remain covered.

Where can I verify Medsafe requirements?

Use Medsafe's medical devices portal and official WAND guidance. Medsafe lists devices@health.govt.nz for medical-device enquiries.

Related New Zealand regulatory topics

See our New Zealand medical device registration overview for sponsor and notification planning.