New Zealand Sponsor for Medical Devices and IVDs

There is no pre-market approval system for medical devices in New Zealand. However, companies must notify their devices to the WAND database within 30 working days of becoming the sponsor. This process does not involve government fees or a review/approval process. While there are no mandatory notifications for IVDs, manufacturers can voluntarily list them in WAND. Despite the absence of mandatory notification, IVDs must comply with the Medicines Act 1981 and its Regulations.

As your New Zealand Sponsor, we will:

• Notify information about your medical devices to the WAND database within the required 30 working days.
• Ensure any inaccuracies or corrections to the notified information are updated within 10 working days.
• Maintain or have access to distribution records of the devices supplied, facilitating efficient contact with all affected users in the event of a recall or corrective action.
• Immediately advise Medsafe of any recall or corrective action affecting medical devices supplied in New Zealand.
• Ensure that the labeling of the medical devices complies with the Regulations.

Secure access to Technical Documentation

We maintain full access to Technical Documentation, reducing the need to share sensitive design details with multiple parties.

Ensure compliance with Sponsor information

Your documentation, including labeling and manuals, must feature the Sponsor’s name and address, ensuring compliance.

Manage distributor changes and avoid recall conflicts

If you change distributors, reprinting labels and manuals is necessary, and conflicts may arise during recalls or incident reporting.