医疗器械监管科学发展和路径研究

Development and Implementation Roadmap of Regulatory Science for Medical Devices

本文全面回顾国内外监管机构和科研人员在监管科学研究中取得的进展与成果,在研究我国药品监管部门医疗器械监管工作需求的基础上,面对当前技术创新和公共卫生事件等对医疗器械监管工作带来的重大挑战,提出医疗器械监管科学工作的必要性和紧迫性。通过以人民健康为中心、以问题为导向、注重实效、科学推进的总体考量,提出8大优先方向、16个实施路径的发展建议,包括监管科学在医疗器械领域研发和应用。在落实发展规划方面,提出了建议推进的18项近期专项课题和6个长期研究领域。在推进策略上,建议优先建设解决现有监管挑战的工作能力;其次,通过长期的投入与发展,完整地构筑医疗器械监管科学研究和应用体系;最终,实现医疗器械产品的全面科学监管。为医疗器械监管部门和科研工作者提供参考。

This report reviews the current progress in regulatory science made by regulatory agencies and researchers both in and outside China,and demonstrates the necessity and urgency of advancing regulatory science based on research of the demands of medical device regulation,which faces major challenges posed by technology innovation and public health crisis.Adhering to the principles of focusing on public health and adopting problem-oriented,pragmatic and scientific approaches,the report proposes a development strategy that incorporates 8 priority fields and 16 implementation roadmaps,covering research and application of regulatory science for medical devices.In terms of execution of the development plan,this report puts forward 18 short-term research projects and 6 long-term research areas.In terms of strategy,the authors suggest first strengthening capacities needed for meeting pressing challenges,then building up an integrated regulatory science research and application system through long-term investment and efforts,and finally realizing scientific regulation for medical devices.This report serves researchers and regulators that are interested in regulatory science for medical devices.