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SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

In addition, considering the fact that one marketing authorization application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorization application is submitted under an abridged procedure (e.g., World Health Organization (WHO). European Medicines Agency (EMA) – Biologics.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. Address gaps in existing compliance requirements.

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