Tag archives: Therapeutic Goods Administration

Australia: Improvements for GMP clearance

Health Law PulseBy on Posted in International
Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) has announced that it is planning improvements around Good Manufacturing Practice (GMP) clearance. As part of this, the TGA will be publishing an updated revision of the GMP clearance guidance document, and redesigning the current GMP Clearance application e-forms. GMP clearance is required for all medicines … Continue reading

Australia – TGA consults on software as a medical device

Photo of Bernard O'Shea (AU)Photo of Rohan Sridhar (AU)By Bernard O'Shea (AU) and Rohan Sridhar (AU) on Posted in International
The Therapeutic Goods Administration (TGA) has opened consultation on the use of software as a medical device (SaMD) as part of the International Medical Device Regulators Forum working group (IMDRF Working Group). The IMDRF Working Group comprises a number of clinical evaluators of medical devices and is seeking views on questions relating to the clinical … Continue reading
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