SQA

DECEMBER 16, 2022

19 Medical Rehabilitation Equipment. This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. CMDE Announcement No. 04 Orthopedic Surgical Instruments. 07 Medical Diagnostic and Monitoring Equipment. 08 Respiration, Anesthesia and First Aid Devices.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

FEBRUARY 26, 2024

These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. This guidance replaces the industry guidelines entitled Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19), which was published in January 2021.

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. Recommendations for stability studies.

FDA 40

FDA Compliance COVID-19 Public Health 40