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www.fdanews.com/articles/166189-industry-bracing-for-hurdles-as-new-chinese-device-regs-take-effect

Industry Bracing for Hurdles as New Chinese Device Regs Take Effect

August 1, 2014

New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, industry experts say.
International Medical Device Regulatory Monitor