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RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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Posted 13 November 2013 | By Louise Zornoza,
China's FDA (CFDA) issued a notice on 6 November 2013 establishing a new administrative review process to take effect as of 1 January 2014 allowing entities to appeal decisions.
A requested review must allege that the specific administrative acts infringe upon the legitimate rights and interests of citizens, legal persons or other entities. The burden will be on the applicant to establish the factual and legal basis for the reconsideration of a specific administrative act. Regulators said the administrative review process will be lawful, fair, open and timely, and that the cost of the process will be borne by the CFDA.
CFDA Notice
Read all Breaking News from Reglink
Tags: Appeals Process
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