Regulatory science for medical devices and evidence-based science_Chinese Journal of Evidence-Based Medicine

Authors：

 ZHANG Kai ^1,2 , SUN Xin ^1,3 , YU Jiajie ^1,3 , TANG Zhonglan ^1,2 , FU Zengxiang ⁴ , XU Bin ^1,2,5 , ZHU Xiangdong ^1,2 , LIANG Jie ^1,6 , LI Youping ^1,3 , ZHANG Xingdong ^1,2

1. Research Base of Regulatory Science for Medical Device, National Medical Products Administration, Institute of Regulatory Science for Medical Device, Sichuan University, Chengdu, 610064, P.R.China;
2. Engineering Research Center in Biomaterial, Sichuan University, Chengdu, 610064, P.R.China;
3. China Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
4. Life College of Northwest Polytechnic University, Xi'an, 710072, P.R.China;
5. Sichuan Food and Drug Inspection and Testing Institute, Chengdu, 611731, P.R.China;
6. Sichuan Medical Device Biomaterials and Products Inspection Center, Chengdu, 610064, P.R.China;

Corresponding author：

ZHANG Kai, Email: kaizhang@scu.edu.cn

Keywords：

Regulatory science; Medical device; Evidence-based science; Evidence-based medicine; Safety; Effectiveness

DOI：

10.7507/1672-2531.201903142

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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 evidence-based scientific tools and methods to demonstrate the safety and effectiveness, as well as quality, efficacy and cost-effectiveness 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.

Citation： ZHANG Kai, SUN Xin, YU Jiajie, TANG Zhonglan, FU Zengxiang, XU Bin, ZHU Xiangdong, LIANG Jie, LI Youping, ZHANG Xingdong. Regulatory science for medical devices and evidence-based science. Chinese Journal of Evidence-Based Medicine, 2019, 19(5): 527-531. doi: 10.7507/1672-2531.201903142 Copy

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1. 中华人民共和国国务院令(第650号). 医疗器械监督管理条例. Available at: http://www.nmpa.gov.cn/WS04/CL2076/300561.html.
2. 国家药品监督管理局(2018年第83号公告). 关于发布创新医疗器械特别审查程序的公告. Available at: http://www.nmpa.gov.cn/WS04/CL2093/331560.html.
3. U.S. Food and Drug Administration. US-FDA CDRH regulatory science priorities (FY2017). Available at: https://www.fda.gov/MedicalDevices/ScienceandResearch/ucm467550.htm.
4. Institute of Medicine. Strengthening a workforce for innovative regulatory science in therapeutic development: Workshop summary. Washington, DC: National Academies Press, 2012.
5. U.S. Food and Drug Administration. A frame work for FDA’s regulatory science initiative-advancing regulatory science for public health. Available at: www.fda.gov/download/scienceresearch/specialtopics/regulatoryscience/ucm228444.pdf.
6. Moghissi AA, Richard AC, Dennis KM, et al. Innovation in regulatory science: metrics for evaluation of regulatory science claims based on best available regulatory science. J Regul Sci, 2017, 7(5): 50.
7. 李幼平, 主编. 实用循证医学. 北京: 人民卫生出版社, 2018.
8. 喻佳洁, 李琰, 陈雯雯, 等. 循证医学的产生与发展: 社会需求、学科发展和人文反思共同推动. 中国循证医学杂志, 2019, 19(1): 108-114.
9. 李琰, 喻佳洁, 陈雯雯, 等. 循证医学的科学观和人文观. 中国循证医学杂志, 2019, 19(1): 114-118.
10. 喻佳洁, 李琰, 陈雯雯, 等. 从循证医学到循证科学的必然趋势. 中国循证医学杂志, 2019, 19(1): 119-124.

Chinese Journal of Evidence-Based Medicine

Regulatory science for medical devices and evidence-based science

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