Guidance

Guidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements.

Guidance on when consumer software products like apps or websites intended to support users' mental health are excluded from our regulatory requirements.

Guidance on when software that provides alerts to health professionals in relation to patient care may be excluded from our regulation.

Guidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements.

Guidance on when software that makes calculations may be excluded from our regulatory requirements.

Software or a combination of software and hardware that is an electronic health record (EHR) may be excluded from our regulatory requirements.

Guidance about when certain types of laboratory information management systems (LIMS) and laboratory information systems (LIS) may be excluded from our regulatory requirements.

Guidance about when certain types of population-based analytics software may be excluded from our regulatory requirements.

Guidance on when software used for clinical workflow management may be excluded from our regulatory requirements.

Guidance on when software products with the sole purpose of storing or transmitting patient images may be excluded from our regulatory requirements.

Guidance on when software used as a patient reported outcome measures (PROMs) questionnaire or patient survey may be excluded from our regulation.

Guidance on when consumer software products that encourage behavioural change to improve general health or wellness may be excluded from our regulations.

Guidance on when software products for consumers to self-manage an existing disease or health condition may be excluded from our regulatory requirements.

Guidance on when software that enables communications to support the delivery of health services may be excluded from our regulatory requirements.

Guidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements.

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.

Guidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.

Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions.

Guidance on how we regulate software-based medical devices.

Understand the regulatory requirements for supplying UDI compliant medical devices in Australia

Understand your role and obligations when manufacturing surgical loan kit components, assembling surgical loan kits, or supplying surgical loan kits to hospitals in Australia.

To use the N2 application pathway using OTC medicine monographs, you must ensure that your application meets the requirements for N2 applications.

Find out whether your application for an umbrella-branded medicine requires a higher level of assessment.

Guidance for healthcare facilities, including information about the requirements for data fields, timeframes for reporting and other considerations.

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).