China Product Registration, Test Protocol Reforms Targeted By AdvaMed
This article was originally published in The Gray Sheet
Executive Summary
AdvaMed is drafting a case study on the regulation of pacemakers in China as a way to pinpoint potential hurdles for U.S. manufacturers
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The Chinese government's pledge to take action by the end of May to eliminate duplicative testing and inspection requirements would help streamline its medical technology registration process, AdvaMed says April 12. The agreement emerged from the 17th annual senior-level meeting of the Joint Commission on Commerce & Trade, concluded April 11 in Washington, D.C. Though testing required separately by China's State Food & Drug Administration and its General Administration of Quality, Supervision, Inspection & Quarantine is intended to focus on efficacy and safety, respectively, industry has noted that the tests can be redundant (1"The Gray Sheet" March 14, 2005, p. 25)...
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