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ANZ Whitepaper
5.4 MB
Medical device registration in Australia and New Zealand
Australia and New Zealand offer attractive opportunities for medical device manufacturers. Each country maintains its own regulatory framework, medical device registration process, and market access requirements and Australia medical device registration requirements differ from New Zealand's notification and market access processes. Understanding registration pathways, sponsor responsibilities and post-market requirements is critical to achieving efficient market entry and maintaining compliance.
Understanding Australia's medical device registration with the TGA regulatory framework
Australia's Therapeutic Goods Administration (TGA) maintains a medical device regulatory system that is influenced by the principles established by the Global Harmonization Task Force (GHTF), and the International Medical Device Regulators Forum (IMDRF). Before most medical devices can be marketed in Australia, they must complete the Australia medical device registration process by being included in the Australian Register of Therapeutic Goods (ARTG). ARTG listings identify critical device information, including classification, intended purpose and Global Medical Device Nomenclature (GMDN) codes.
The TGA continues to align many aspects of its regulations with the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR), including device classification rules and Unique Device Identification (UDI) requirements. Manufacturers should understand these evolving requirements when developing regulatory strategies for the Australian market.
Device classification and conformity assessment
Medical devices and IVDs in Australia are classified according to risk-based rules defined in Australian legislation. Compliance with the Essential Principles for safety and performance is mandatory, and standards such as ISO 13485 are commonly used to demonstrate conformity. Depending on device classification, manufacturers may leverage various conformity assessment routes and regulatory evidence to support market access applications.
Leveraging overseas regulatory approvals
The TGA accepts regulatory evidence from several comparable international authorities and programs. Manufacturers may be able to leverage CE marking certificates, MDSAP certifications, FDA-related assessments, Health Canada authorizations, Japan PMDA approvals and other acceptable evidence to support registration activities. However, the TGA may still conduct application audits or request additional documentation depending on device risk and classification.
Australian sponsor responsibilities
Manufacturers without a local Australian presence must appoint an Australian sponsor. The sponsor serves as the regulatory liaison with the TGA and is responsible for ARTG submissions, fee management, post-market vigilance reporting and other regulatory obligations. Selecting the appropriate sponsor is therefore an important component of a successful market access strategy.
New Zealand medical device notification with Medsafe
New Zealand's medical device authority, Medsafe, currently operates a notification-based system through the Web Assisted Notification of Devices (WAND) database. Medical devices must generally be notified in WAND, while IVD notification remains voluntary. Manufacturers must maintain evidence demonstrating device safety and effectiveness and provide it upon request.
Like Australia, foreign manufacturers must appoint a local representative in New Zealand. Ongoing regulatory reforms are expected to modernize the country's medical product regulations, making it important for manufacturers to stay informed about changing requirements.
Post-market compliance and vigilance
Both Australia and New Zealand require manufacturers and sponsors to maintain post-market compliance activities. These include adverse event reporting, vigilance activities, recalls and maintenance of current registration information. Australia imposes particularly robust vigilance requirements under the TGA framework, while New Zealand requires reporting of adverse events and recall actions through Medsafe.
Download the medical device registration white paper
Download Medical Device Registration in Australia and New Zealand: Overview of the TGA and Medsafe Registration Processes, Timelines and Costs to gain practical insights into registration pathways, sponsor responsibilities, classification requirements, regulatory timelines and post-market obligations.
Frequently Asked Questions
- Can CE marking replace an Australian Register of Therapeutic Goods (ARTG) application?
No, CE marking does not replace an application for inclusion in the ARTG. However, recognized European conformity assessment documentation may be used as supporting evidence for an ARTG inclusion application, depending on the device and applicable requirements. If acceptable market authorization evidence from a comparable overseas regulator or assessment body is not available, a conformity assessment certificate issued by the Therapeutic Goods Administration (TGA) may be required.
- Do in vitro diagnostic (IVD) devices need Web Assisted Notification of Devices (WAND) notification in New Zealand?
No, IVDs are exempt from WAND notification requirements. Sponsors may voluntarily notify their IVDs in WAND if desired.
- Can one company act as the local representative in both Australia and New Zealand?
Australian and New Zealand have separate sponsor requirements. An Australian sponsor must meet the applicable requirements in Australia, while a New Zealand sponsor must meet the applicable requirements in New Zealand. An Australian sponsor cannot act as the New Zealand sponsor solely based on its Australian sponsor status, and vice versa.
- What information should manufacturers check before submitting device details to ARTG inclusion or WAND notification?
Australia: Confirm that the device meets the Australian Essential Principles, including applicable Unique Device Identification (UDI) labeling requirements, and is correctly classified. For Class I sterile or measuring devices and higher classifications, confirm that the device is covered by the applicable overseas market authorization. Check that the Global Medical Device Nomenclature (GMDN) code is accurate, the Australian Declaration of Conformity (DoC) is signed and the sponsor is identified on the labeling. Also confirm that the clinical evaluation report (CER) is current and that Australia is addressed in applicable post-market surveillance (PMS) and vigilance procedures.
New Zealand: Confirm that evidence of safety and effectiveness is available, the device is correctly classified and the GMDN code is accurate.
- What could cause an Australian medical device application to undergo an audit?
Certain higher-risk medical device applications may be subject to a mandatory audit by the TGA, depending on the device classification and the type of evidence used to support the application. The TGA may also select other applications for a nonmandatory audit based on factors such as concerns about application details (e.g. device characteristics or classification), interest in reviewing additional documentation (e.g. clinical evidence, risk management report), considerations related to the device, manufacturer or sponsor, recent regulatory affecting the device, or a prior TGA post-market review.
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