Action Plan for Medical Devices
Posts published in “Therapeutic Goods Administration – TGA”
Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices
Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems Consultation: Proposed new…
Brexit – Implications for therapeutic goods in Australia
Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Consultation: Regulation of software, including Software as a Medical Device (SaMD)
TGA Consultation: Good Clinical Practice Inspections Program
Webinar: The role of the TGA in digital health
TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy
TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia