SQA

DECEMBER 16, 2022

It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

FEBRUARY 26, 2024

These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. The MDVP pilot aims to identify areas that may require improvement in order to ensure appropriate monitoring and communications are in place to support the ongoing safety of medical devices available to the Australian public.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

FEBRUARY 26, 2024

Sponsors need to have systems in place to monitor the performance of the devices they supply, receive, update, and maintain information about their devices and report details of adverse events and performance issues to us.These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

FDA 40

FDA Compliance COVID-19 Public Health 40