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SQA Regulatory Surveillance Summary 1 | Monthly Update 2021

SQA

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 Regulatory Surveillance Summary | Monthly Update 2024

SQA

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. More than ever, businesses today need a framework to guide them on their AI journey. Recommendations for stability studies.

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