Get The Right Advice On Your Regulatory Strategy
Medical devices are regulated in Australia under the Therapeutic Goods Act. They must be registered with the Therapeutic Goods Administration (TGA) and included in the Australian Register for Therapeutic Goods (ARTG).
Examples of medical devices include thermometers, blood pressure monitors, blood glucose monitors, etc.
Examples of products which are not classified as medical devices include BMI monitors/scales and heart rate monitors (sports).
The experts at Market Access (AUS) Pty Ltd can advise you on the applicable regulatory strategy and requirements for your medical devices.
Importer or Overseas Manufacturer?
If you are an importer or an overseas manufacturer of medical devices, Market Access (AUS) Pty Ltd can be your agent or local sponsor and register your device on the ARTG.