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FDAnews Device Daily Bulletin
Oct. 17, 2012 | Vol. 9 No. 204
China: SFDA Draft Aims to Bolster Quality of Device Clinical Trials
China’s proposed update to good clinical practice requirements for medical devices includes tougher provisions on ethics committees and human subject protections. Sponsors are warned not to provide misleading information about possible adverse effects of experimental devices or to exaggerate the compensatory benefits of participating in a clinical trial.
International Medical Device Regulatory Monitor
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