【摘要】 医疗器械监管科学是服务于医疗器械监管的科学研究和活动。循证科学所提倡的"科学和透明原则,开展证据为本"的原则也适用于医疗器械监管科学的相关活动,即采用循证科学的工具和方法,通过证据证明产品全生命周期、使用人群、范围的安全有效和质效与成本-效果。循证科学为医疗器械监管科学提供全新的方法和工具,也为制定科学监管决策提供新依据。更多还原

【Abstract】 Regulatory science of medical devices serves the scientific research and regulatory activities for supervision of medical devices. Principles of science and transparency and conduction of evidence-based study, which is advocated in Evidence-based science(EBS), also apply to regulatory science of medical devices, including using evidencebased scientific tools and methods to demonstrate the safety and effectiveness, as well as quality, efficacy and costeffectiveness of total life cycle of medical products, target customers, and scope. EBS provides both new methods and tools for regulatory science for medical devices, and provides a new basis for further scientific regulatory decisions.更多还原