Remove 2002 Remove Compliance Remove Governance Remove World Health
article thumbnail

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.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

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