2001 Compliance Informed Consent 
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.
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.
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