亚洲社会药学
亚洲社会药学

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›› 2015, Vol. 10 ›› Issue (3): 123-129.doi:

• 论文 • 上一篇    下一篇

Analysis and Evaluation of Measures for the Administrationof Medical Device Registration

LI Fei1,2, BI Kai-shun1   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China;2. Liaoning Center for Drug and Device Evaluation and Monitoring, Shenyang 110003, China
  • 收稿日期:1900-01-01 修回日期:2015-11-01 出版日期:2015-09-20 发布日期:2015-09-20
  • 通讯作者: BI Kai-shun

Analysis and Evaluation of Measures for the Administrationof Medical Device Registration

LI Fei1,2, BI Kai-shun1   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China;2. Liaoning Center for Drug and Device Evaluation and Monitoring, Shenyang 110003, China
  • Received:1900-01-01 Revised:2015-11-01 Online:2015-09-20 Published:2015-09-20
  • Contact: BI Kai-shun

摘要： Objective To study Measures for the Administration of Medical Device Registrations published by CFDA in 2014 and to summarize
its impact on medical device market access in China. Methods Comparative study was adopted to conduct a research on the new and
old measures for the administration, and systematic analysis was used to study the innovations of the measures for the administration.
Results and Conclusion The new measures for the administration have made some improvements in the statutory code, efficiency
and convenience as well as unity of licensing and supervision as an administrative license system. Additionally, the new provisions
have made innovations on the subject qualification, evaluation principles and evaluation system. In order to implement the new
measures for the administration, further reforms should be carried out on the uniform standards and personnel training to promote the
registration management system.

关键词: medical device, measures for the administration of registration, medical device, market access, administrative license

Abstract: Objective To study Measures for the Administration of Medical Device Registrations published by CFDA in 2014 and to summarize
its impact on medical device market access in China. Methods Comparative study was adopted to conduct a research on the new and
old measures for the administration, and systematic analysis was used to study the innovations of the measures for the administration.
Results and Conclusion The new measures for the administration have made some improvements in the statutory code, efficiency
and convenience as well as unity of licensing and supervision as an administrative license system. Additionally, the new provisions
have made innovations on the subject qualification, evaluation principles and evaluation system. In order to implement the new
measures for the administration, further reforms should be carried out on the uniform standards and personnel training to promote the
registration management system.

Key words: medical device, measures for the administration of registration, medical device, market access, administrative license

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