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

SQA

DECEMBER 16, 2022

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.

FDA 40
FDA Compliance COVID-19 Licensing 40
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SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

APRIL 30, 2021

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.

COVID-19 Vaccine 52
COVID-19 Vaccine COVID-19 Compliance Governance 52
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