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.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. 19 Medical Rehabilitation Equipment.

FDA 40

FDA Compliance COVID-19 Licensing 40

HIPAA Journal

DECEMBER 14, 2022

The CARES Act was passed by Congress on March 27, 2020, to ensure that every American has access to the care they need during the COVID-19 pandemic and to address the economic fallout from the 2019 Novel Coronavirus and COVID-19. The compliance date for the CMS rule was July 1, 2021.

HIPAA 124

HIPAA COVID-19 COVID-19 Vaccine Compliance 124

SQA

AUGUST 2, 2021

ISO/TS 22421 was developed by technical committee ISO/TC 198, Sterilization of Health Care Products, whose secretariat is held by the American National Standards Institute (ANSI), ISO’s member for the USA. COVID-19 Response: Freely Available ISO Standards, 18 June 2021.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52

FDA Compliance COVID-19 Public Health 52