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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

MAY 17, 2022

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022.

FDA 75
FDA Compliance Informed Consent Hospitals 75
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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., European Medicines Agency (EMA) – Biologics.

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