Dear Members, TGA has posted Guidance on Software based medical device exclusions for specific uses.
Software-based medical device exclusions | Therapeutic Goods Administration (TGA)
| TGA – Guidance – Understanding the health facility management software exclusion – Guidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the communications software exclusion – Guidance on when software that enables communications to support the delivery of health services may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the general health or wellness software exclusion – Guidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the image storage and transmission software exclusion – Guidance on when software products with the sole purpose of storing or transmitting patient images may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the clinical workflow management software exclusion – Guidance on when software used for clinical workflow management may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the electronic health records software exclusion – Software or a combination of software and hardware that is an electronic health record (EHR) may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the middleware for health systems exclusion – Guidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the calculator software exclusion – Guidance on when software that makes calculations may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the population-based analytics software exclusion – Guidance about when certain types of population-based analytics software may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the laboratory information management software exclusion – Guidance about when certain types of laboratory information management systems (LIMS) and laboratory information systems (LIS) may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding the health self-management software exclusion – Guidance on when software products for consumers to self-manage an existing disease or health condition may be excluded from our regulatory requirements. View article… |
| TGA – Guidance – Understanding when health alert software systems qualify for exclusion – Guidance on when software that provides alerts to health professionals in relation to patient care may be excluded from our regulation. View article… |
| TGA – Guidance – Understanding the behavioural change or coaching software exclusion – Guidance on when consumer software products that encourage behavioural change to improve general health or wellness may be excluded from our regulations. View article… |
| TGA – Guidance – Understanding the patient survey software exclusion – Guidance on when software used as a patient reported outcome measures (PROMs) questionnaire or patient survey may be excluded from our regulation. View article… |
| TGA – Guidance – Understanding the digital mental health tool software conditional exclusion – Guidance on when consumer software products like apps or websites intended to support users’ mental health are excluded from our regulatory requirements. View article… |
