SQA

DECEMBER 16, 2022

This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. It also fosters innovation in this crucial biotech sector. The framework contains parallel provisions for donor selection, quality and safety management and oversight.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

FEBRUARY 26, 2024

These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. World Health Organization (WHO) Medical Product Alert N°7/2023: Falsified DEFITELIO (defibrotide), 04 September 2023 This WHO Medical Product Alert refers to one falsified batch of DEFITELIO (defibrotide sodium).

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