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.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

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

FEBRUARY 26, 2024

The MHRA has received reports of a very small number of people who have been hospitalized after using potentially fake pens. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. Buying prescription-only medicines online without a prescription poses a direct danger to health.

FDA 52

FDA Compliance COVID-19 Public Health 52