Entering The Australian Medical Device Market: A Practical Guide

Confirm your product is a medical device

First, determine whether your product falls within the Australian definition of a medical device. In particular, the device’s intended purpose, indications and claims are important considerations and form the foundation for the regulatory pathway that follows.

Determine the Australian device classification

Next, medical devices are classified according to the level of risk associated with their use. For example, general medical devices range from Class I through Class IIa and IIb to Class III, while separate classifications apply to certain other device types. Classification is important because it influences the regulatory evidence, conformity assessment and application requirements that apply.

However, manufacturers should not assume that a classification assigned in another jurisdiction will automatically be the same in Australia. Instead, the device should be assessed against the applicable Australian classification rules.

Assess compliance with the Essential Principles

In addition, medical devices supplied in Australia must comply with the applicable Essential Principles for safety and performance. Specifically, manufacturers are responsible for holding appropriate evidence demonstrating compliance with these requirements, which may include technical, scientific, engineering, risk-management and clinical evidence, depending on the device.

Additionally, the TGA also provides an Essential Principles checklist that can be used to document how the applicable requirements have been addressed.

Confirm the appropriate regulatory evidence

Furthermore, manufacturers must have appropriate evidence demonstrating that the applicable conformity assessment procedures have been completed. Depending on the device and regulatory pathway, the TGA may accept certain evidence issued by comparable overseas regulators and assessment bodies. However, approval in another market does not automatically mean that a device can be supplied in Australia.

As a result, existing regulatory evidence should therefore be assessed against the Australian device classification and applicable regulatory pathway before proceeding with an application.

Review your technical and clinical documentation

Likewise, the manufacturer must maintain documentation supporting the safety, performance and regulatory compliance of the device. For example, depending on the device, this may include:

• Device descriptions and specifications
• Risk-management documentation
• Verification and validation evidence
• Clinical evidence and clinical evaluation
• Biological safety information
• Labelling
• Instructions for Use
• Evidence demonstrating compliance with the Essential Principles

Consequently, identifying documentation gaps before an ARTG application is submitted can help reduce regulatory uncertainty later in the process.

Appoint an Australian Sponsor

Importantly, an overseas manufacturer requires an Australian Sponsor to supply medical devices in Australia. In particular, the Sponsor is an Australian-based legal entity that acts as the primary regulatory contact between the manufacturer and the TGA. Moreover, the Sponsor’s responsibilities extend beyond the initial application and include important ongoing regulatory and post-market obligations.

Therefore, choosing an Australian Sponsor should be considered an important part of the manufacturer’s Australian market-entry strategy.

Apply for inclusion in the ARTG

Next, most medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia, unless an exemption or other applicable pathway applies. After that, the Australian Sponsor submits the application to the TGA.

In addition, the application requirements depend on factors including the device classification and regulatory evidence being relied upon. Similarly, some applications may also be subject to TGA assessment or audit requirements.

Consider Australian labelling and UDI requirements

Besides that, manufacturers should also assess Australian requirements relating to:

• Device labelling
• Instructions for Use
• Patient information materials, where applicable
• Unique Device Identification (UDI) requirements

Ideally, these requirements should be considered as part of the market-entry process rather than after ARTG inclusion.

Maintain compliance after market entry

Finally, ongoing obligations continue after a medical device is supplied in Australia. For example, these can include requirements relating to:

• Complaints and adverse events
• Post-market surveillance
• Safety and performance
• Regulatory and device changes
• TGA requests for information
• Recalls and corrective actions
• Maintaining appropriate regulatory evidence

Overall, Australian market access should therefore be considered an ongoing regulatory lifecycle rather than simply a registration exercise.