The Australian medical device market is mature, with a well-formed regulatory system, and is growing consistently over the years. Based on the Medical Technology Association of Australia reports in 2021, the total market for medical devices in Australia is estimated at over US$5.37 billion, compared with the market valuation of the medical devices industry in 2017 with approximately US$4.6 billion. Australia has become a competitive and prospective market and demands a wide range of innovative medical devices.

Approximately 80% of the medical device in Australia are imported, while nearly all medical technology products manufactured in Australia are exported. Australia is the 8th largest market for U.S. medical device exporters. Key suppliers include the United States, the European Union, and Japan. Typically, medical devices distributors may also have a subsidiary office in New Zealand.

Therapeutic Goods Administration (TGA) is the local authority in Australia that is part of the Australian Government Department of Health and was established in 1989 to protect the health and wellbeing of the community by regulating and monitoring all therapeutic goods (medical devices included) that are distributed in Australia. Medical devices are well defined in section 41BD of the Therapeutic Goods Act 1989 (the Act). All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002. In general, medical devices are:

-         used for humans;

-         intended to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body generally achieve their purpose by physical, mechanical, or chemical action.

TGA assesses medical devices depend on a risk-based approach as above-mentioned. The higher the potential risks of a medical device, the more they need to be examined and monitored. The devices of the lower risk, such as bandages, rely on the applicant's certification of compliance with regulatory requirements, whereas those of the higher risk, such as pacemakers, involve a direct evaluation of the available evidence by the TGA officers. Generally, the classification from the low to high risk is suggested to be Class I (non-measuring, non-sterile), Class I (measuring, sterile), Class IIa, Class IIb, Class III, and Active implantable medical devices (AIMD). Besides, with regards to In vitro diagnostic medical devices (IVDs), they are typically pathology tests (and related instrumentation) used to carry out testing on human samples where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management. There are four classes in Classification of IVDs, which considers the health risk either on the public or an individual, that may occur where an incorrect result arises from their use, and generally, the higher the potential risk an incorrect result would pose, the higher the classification.

Sponsors must apply for inclusion of their medical device (IVD medical devices also included), in the Australian Register of Therapeutic Goods (ARTG). The steps in the medical device inclusion process are covered as follows:

Australia Government has agreed for TGA to make use of authorization evidence overseas and will recognize when devices have been approved by comparable overseas regulators. TGA has long accepted certification from European notified bodies as evidence of compliance with the conformity assessment procedures, in addition to the conformity assessment certificates issued by the TGA. Since October 2018, comparable overseas regulators and assessment bodies include:

Notified bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union.

- the Food and Drug Administration of the United States

- Health Canada

- Medical Device Single Audit Program (MDSAP) Auditing Organisation

- the Ministry of Health, Labour and Welfare, and Pharmaceutical and Medical Devices Agency of Japan.

Qualtech, as a team with technical background, can provide tailored services for you, and have extensive strategical product registration experience to obtain product license to be released in the market.

Today, we are privileged to connect with thousands of customers with more than thousands of medical devices in 15 countries and completed hundreds of clinical trials, we can help you seize the opportunity to enter this market with all aspects of the TGA registration process, as well as assist you to connect with local distributors. Eventually, we will lead you to a smooth journey towards the expansion of your products into the Australian medical device market. Your success in Australia is our goal.





Healthcare Resource Guide: Australia

MTAA Pre-Budget Submission FY2021/22

Australia - Country Commercial Guide

Services Australia

TGA regulatory framework

Therapeutic Goods Act 1989

Standards, guidelines & publications (medical devices & IVDs)

Overview of medical devices and IVD regulation

Product regulation according to risk

TGA regulatory framework

Medical device inclusion process

Comparable overseas regulators for medical device applications