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www.fdanews.com/articles/159296-china-in-country-experience-is-paramount-experts-say

China: In-Country Experience Is ‘Paramount,’ Experts Say

October 25, 2013
The China Food and Drug Administration is asking for increasing amounts of information on raw materials used in medical devices, in some cases far more than would be found in an FDA master access file, says Shawn Shorrock, global regulatory affairs director at Solvay Advanced Polymers.
Devices & Diagnostics Letter