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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. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13. World Health Organization (WHO).

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SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance. These missions will allow the Commission to identify, and, if necessary, correct any non-compliance or weaknesses.

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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.

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