Medical Device Registration in Australia and New Zealand: An Overview

Australia and New Zealand offer significant market opportunities for medical device manufacturers. While both countries have distinct regulatory frameworks, there are important linkages that can streamline market entry.

Australia: TGA and ARTG

Medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). Devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied.

Key Steps for ARTG Inclusion:

Classification: Determine the device classification under Australian regulations (Class I, IIa, IIb, III, AIMD).

Conformity Assessment: For most devices, conformity assessment is required. Devices with CE marking or FDA approval may qualify for simplified assessment pathways.

Australian Sponsor: Foreign manufacturers must appoint an Australian Sponsor who is responsible for the device's compliance and post-market obligations.

ARTG Application: Submit the application through the TGA's online portal.

Post-Market Obligations: Once included, the sponsor must comply with post-market surveillance, incident reporting, and advertising requirements.

New Zealand: Medsafe and WAND

Medical devices in New Zealand are regulated by Medsafe. Rather than requiring pre-market approval for most devices, New Zealand operates a notification system.

Key Steps for WAND Notification:

Determine if Notification is Required: Some devices are exempt from notification, while others must be notified.

Appoint a New Zealand Sponsor: The sponsor is responsible for the notification and ongoing compliance.

Submit WAND Notification: Notifications are submitted through the Web Assisted Notification of Devices (WAND) system.

Reference Country Approvals: New Zealand recognizes approvals from certain reference countries (including Australia, EU, USA, Canada, and Japan), which can streamline market entry.

Post-Market Surveillance: Sponsors must monitor device safety and report adverse events.

Leveraging Trans-Tasman Arrangements

Australia and New Zealand have a Trans-Tasman Mutual Recognition Arrangement (TTMRA) that allows certain goods approved in one country to be supplied in the other. However, medical devices have specific requirements, and manufacturers should verify whether their device qualifies for mutual recognition.

How We Help

Veritas Quality Solutions assists manufacturers with both TGA and Medsafe registration, including classification, sponsor arrangements, application preparation, and post-market compliance.