Preparing to Enter the Australian Market with Your Medical Devices
The marketing of medical devices in Australia is regulated by the Therapeutic Goods Administration (TGA). Unless specifically exempted or excluded, medical devices must be listed in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia.
Access to the Australian market depends, in particular, on the product’s qualification, its classification, demonstration of compliance with the Essential Principles, the availability of evidence of conformity assessment, and the submission of an application for inclusion in the ARTG.
What does inclusion in the ARTG mean?
The ARTG is the Australian Register of Therapeutic Goods. To be made available in Australia, a medical device must generally be listed in this register under the responsibility of an Australian sponsor.
Inclusion in the ARTG requires demonstrating that the device meets the applicable requirements, particularly with regard to safety, performance, classification, conformity assessment, labeling, and technical documentation.
The TGA specifies that applications for inclusion in the ARTG require, among other things, verifying that the product should indeed be included, identifying the type, determining the classification, preparing the supporting documentation, and, if necessary, undergoing a compliance audit.
Role of the manufacturer and the Australian sponsor
The manufacturer is responsible for the design, manufacture, compliance, and technical documentation of the device. Therefore, the manufacturer must have evidence to demonstrate that the device complies with the applicable regulatory requirements.
The Australian sponsor is the entity established in Australia that applies for the device’s inclusion in the ARTG and assumes certain local regulatory obligations, particularly with respect to the TGA. The market access strategy must therefore clarify the respective responsibilities of the manufacturer and the sponsor, as well as the documents that must be available prior to submission.
Our Support
Isocèle Conseil assists manufacturers of medical devices and in vitro diagnostic medical devices in their efforts to enter the Australian market.
We determine the product’s regulatory status, its risk class, and the applicable requirements under Australian regulations.
We determine the most appropriate strategy based on the type of device, the evidence already available, the markets where the device is already approved, and the commercialization objectives in Australia.
We assess the device’s compliance with Australian essential requirements and identify the necessary supporting documentation.
We prepare or review the materials required for the application for inclusion in the ARTG, in coordination with the manufacturer and the Australian sponsor.
We assist the manufacturer in analyzing supplemental requests and preparing regulatory, technical, or clinical responses.
We help you organize post-market surveillance, change management, and the maintenance of the compliance documentation required for the Australian market.
Why seek guidance?
Gaining access to the Australian market requires a thorough understanding of the TGA’s expectations, the ARTG requirements, the Essential Principles, evidence of compliance assessment, and the role of the Australian sponsor.
Specialized support helps to:
- ensure the qualification and classification of the device;
- identify acceptable regulatory evidence;
- make the most of data already available in other markets;
- verify compliance with the Essential Principles;
- prepare a coherent proposal before submission;
- anticipate the TGA’s requests;
- Organize efforts to ensure continued compliance after inclusion in the ARTG.
Are you interested in marketing a medical device in Australia?
Isocèle Conseil assists you in defining your Australian regulatory strategy, preparing your application for inclusion in the ARTG, and ensuring that your medical devices remain compliant on the Australian market.
Whether your device is already CE-marked or still in development, we can help you develop an approach tailored to your device, its risk class, and your business objectives.
Contact us to discuss your plans for entering the Australian market.