中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 601-605.
DOI: 10.19803/j.1672-8629.2021.07.01

• 专家论坛 • 上一篇    下一篇

监管科学理念对医疗器械警戒制度建设的启示

毛振宾1, 刘树郁1,2   

  1. 1国家药品监督管理局,北京 100037;
    2中山大学,广东 广州 510275
  • 收稿日期:2021-03-23 出版日期:2021-07-15 发布日期:2021-07-23
  • 通讯作者: *许明哲,男,博士,抗感染药物质量评价。E-mail：Xumzhe@nifdc.org.cn
  • 作者简介:毛振宾,男,博士,药品监管科学。国家药品监督管理局科技和国际合作司一级巡视员。曾任大学教授、科技县长,总农艺师;国家食品药品监督管理局稽查专员兼药品安监司主要负责人、投诉举报中心主任、食品安全监管司司长;国家食品药品监管总局稽查局局长、应急管理司司长、科技和标准司临时主要负责人等职务。十几年来从事食品药品监管战略和体系研究,近2年专注药品和医疗器械监管科学研究。 王晨,男,本科,抗感染药物质量评价。

Implications of Regulatory Science for the Construction of Medical Device Vigilance Systems

MAO Zhenbin1, LIU Shuyu1,2   

  1. 1National Medical Products Administration, NMPA, Beijing 100037, China;
    2Sun YatSen University, SYSU, Guangdong Guangzhou 510275, China
  • Received:2021-03-23 Online:2021-07-15 Published:2021-07-23

PDF (PC)

211

摘要： 通过回顾世界发达国家监管科学的发展历程,结合其对医疗器械警戒体系构建的研究,探讨中国特色医疗器械监管科学和警戒制度的发展思路和方法,提出医疗器械监管科学创新的5个优化战略和建立医疗器械监管科学7个学科,明晰中国特色医疗器械警戒制度建立和创新发展的重点和方向。

关键词: 监管科学, 医疗器械, 警戒制度

Abstract: By reviewing the development of regulatory science in developed countries, and based on the research on the construction of medical device vigilance systems, the evolution and methods of regulatory science and vigilance systems of medical devices in China were explored while five strategies for innovation and optimization and seven disciplines of regulatory science of medical devices were proposed. The priorities for the establishment and innovation of the medical device vigilance system with Chinese characteristics were specified.

Key words: regulatory science, medical devices, vigilance system

中图分类号: