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SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. The review has two purposes: To ensure devices included in the ARTG continue to meet the essential principles set out in the Therapeutic Goods (Medical Devices) Regulations 2002.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

ISO/IEC 42001 , the world’s first AI management system standard, meets that need. 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.

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