Australia Medical Device Regulations Definition
The Therapeutic Goods Administration (TGA) oversees the supply of medical devices and in vitro diagnostic (IVD) devices in Australia. Its role is to ensure the safety and effectiveness of devices prior to and following market entry.
Requirements for device classification, conformity assessment, market approval, and post-market monitoring of devices are detailed in the Therapeutic Goods (Medical Devices) Regulations. Additional guidance is published in the Australian Regulatory Guidelines for Medical Devices (ARGMD).
In accordance with TGA’s regulatory framework, medical and IVD devices must be listed in the Australian Register of Therapeutic Goods (ARTG) to be lawfully sold in Australia. Medical devices are categorized according to their risk levels (Class I, IIa, IIb, III, and active implantable medical devices). Likewise, IVD devices are categorized according to their intended use and the public health or personal risk that may arise from an incorrect result (Class 1, 2, 3, and 4).
Manufacturers must maintain evidence demonstrating that their device complies with Essential Principles related to safety, quality, design, and performance. The TGA conducts a conformity assessment to determine if the device performs as intended and conforms to the Essential Principles. The assessment typically entails the review of the manufacturer’s QMS documentation as specified in ISO 13485.
Following device certification and registration, manufacturers must continually monitor the safety and performance of their device through adverse event reporting and other post-market surveillance activities.
Recent updates to the regulation have enhanced oversight in domains such as software as a medical device (SaMD), personalized medical devices, and implantable products. The regulation seeks to align with international standards while accommodating emerging technologies and market demands.
