1. Basic resources: 3 items
    1. Australian regulatory guidelines for medical devices (ARGMD) - Therapeutic Goods Administration (TGA)

      Webpage Recommended

  2. Classification of medical devices 1 item
    1. What classification is my medical device? - Therapeutic Goods Administration (TGA)

      Webpage Recommended Classification Rules for Medical devices: Schedule 2 Classification Rules for IVDs : Schedule 2A

  3. The overall regulatory process for a biomedical device approval 2 items
    1. Medical device inclusion process - Therapeutic Goods Administration (TGA)

      Webpage Recommended

  4. Biomedical devices for various applications/delivery routes: 1 item
    1. What classification is my medical device? - Therapeutic Goods Administration (TGA)

      Webpage Recommended

  5. In-vitro diagnostic devices 1 item
    1. IVD medical devices regulation basics - Therapeutic Goods Administration (TGA)

      Webpage Recommended

  6. Device life cycle, incidence reporting, and recall 4 items
    1. Australian regulatory guidelines for medical devices (ARGMD) - Therapeutic Goods Administration (TGA)

      Webpage Recommended

    2. Transvaginal (urogynaecological) surgical mesh hub - Therapeutic Goods Administration (TGA)

      Webpage Recommended

  7. Software and apps for medical purposes 4 items
    1. Regulation of Software as a Medical Device - Therapeutic Goods Administration (TGA)

      Webpage Recommended

    2. Cyber security for medical devices and IVDs - Therapeutic Goods Administration (TGA)

      Webpage Recommended

  8. Regulatory reforms (International Medical Device Regulators Forum (IMDRF): 3 items
  9. Past Central Exam Papers 1 item
    1. Past Central Exam Papers

      Webpage  Follow the link and search for past exam papers by course code.