Smoother sailing in China?
This article was originally published in The Gray Sheet
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)...
You may also be interested in...
AdvaMed is drafting a case study on the regulation of pacemakers in China as a way to pinpoint potential hurdles for U.S. manufacturers
Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.
President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.