Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors and X-ray equipment. They generally have a physical or mechanical effect on the body, or are used to measure (or monitor) the body and its functions.

General

• Advice about medical devices for health professionals
  How health professionals can find TGA advice about medical devices
• Medical device cyber security information for users
  Guidance for consumers, health professionals, small business operators and large scale service providers
• Medical devices: providing feedback to the TGA
  There are various feedback mechanisms available
• Medical devices reforms
  The TGA has begun work on a series of reforms to the regulation of medical devices, including the hip, knee and shoulder joint implant reclassification

In vitro diagnostics (IVDs)

• False-positive troponin results
  Given the sensitivity of modern troponin tests, health professionals should be alert to the potential for false positive results and the associated risk of unnecessary patient treatment

Implantable devices

• Patient information material for implantable medical devices
  On 26 October 2017, the Government approved regulations to require patient information materials to be supplied with implantable and active implantable medical devices in Australia
• Surgical mesh up-classification
  Important guidance to medical practitioners on the up-classification of new surgical mesh devices with effect from 1 December 2020 and 1 December 2021
• Breast implant hub
  This information hub aims to help the Australian public find information and support related to breast implants
• Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)
  Information for health professionals on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)
• Metal-on-metal hip replacement implants
  Updated information for general practitioners, orthopaedic surgeons and other health professionals
• Transvaginal (urogynaecological) surgical mesh hub
  This information hub aims to help the Australian public find information and support related to transvaginal (urogynaecological) surgical mesh devices

Safety information

• Changes to labelling and regulation of hard surface disinfectants (commencing 1 April 2019)
  These changes took effect on 1 April 2019 and will have an impact on healthcare facilities
• Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration
  Philips has agreed to notify of any actual or anticipated shortages of accessories, repair parts and consumables of the HeartStart MRx in Australia until 31 December 2022
• Reducing the public health risks associated with reusable medical devices
  Examines the public health issues associated with reusable medical devices that are difficult to clean, disinfect and sterilise

Importing and supplying

• Custom made medical devices
  A health professional who imports or supplies a custom-made device, or obtains a custom-made device directly from the manufacturer for supply to their patient, will be a sponsor and have legal obligations under the Regulations
• Importing & supplying medical devices
  The TGA regulates all medical devices that are imported into, supplied in or exported from Australia under the Therapeutic Goods Act 1989