Bill of Health

OCTOBER 31, 2022

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes , creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development. By Aparajita Lath. However, some suggest that patents are impeding access to research. 3d 1351 (Fed.

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SQA

FEBRUARY 22, 2021

NMPA Adjusts Classification Catalog and Down-Classifies Some Medical Devices, 19 January 2021. China’s UDI pilot program wrapped up at the close of 2020; it was previously slated to end in October, but the NMPA extended this trial period due to the impact of the COVID-19 pandemic. China Guidances and Regulations.

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SQA

SEPTEMBER 2, 2022

ANVISA published the RDC 702/2022, which repeals some requirements that were instituted to speed market approval of devices needed to treat patients during the height of the COVID-19 pandemic. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. 27 May 2022.

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HIT Consultant

JANUARY 20, 2022

4 As the most accessible healthcare providers, especially in medically underserved and rural areas, pharmacists most recently played a crucial role in helping the nation combat COVID-19 through administering vaccines, testing, and therapeutics. Community Pharmacists’ Contributions to Disease Management During the COVID-19 Pandemic.”

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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.

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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.

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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.

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