Notification on Senior Training Class of Innovative Medical Devices

  • 2016-09-14

To all concerned,

In order to ensure safety and effectiveness of medical devices, encourage research and innovation of medical devices, enhance the promotion and application of new technologies of medical devices, and promote the development of medical devices industry, China Food and Drug Administration published Special Approval Procedure on China's Innovative Medical Devices, (Trial). In order to help medical devices enterprises learn related regulations and rules, as well as understand work flow and requirements of declaration and review for innovative medical devices, and make application materials fully prepared, Center for Medical Device Evaluation of CFDA made a decision to hold senior training class for innovative medical devices in Hangzhou in middle October, 2016.

Training Contents and Qualified Teachers

1. Summaries and relevant interpretations of innovative medical devices examination

Speaker: Deng Gang (deputy director of Center for Medical Device Evaluation, China Food and Drug Administration)

2. The state-of-the-art and trends of innovative biomedical materials

Speaker: Zhang Xingdong (academician of Chinese Academy of Engineering, foreign academician of America National Academy of Engineering, and president of Chinese Committee for Biomaterials)

3. Development opportunities and challenges of innovative cardiovascular medical devices

Speaker: Han Yaling (academician of Chinese Academy of Engineering)

4. Research thoughts and practice of orthopedics innovative medical devices

Speaker: Liu Zhongjun (director of comprehensive surgical department in Peking University Third Hospital)

5. Introduction of expert review practice of innovative medical devices

Speaker: Gu Hanqing (vice-director of Chinese Society of Biomedical Engineering)

6. Declaration requirements of special application for innovative medical devices and FAQs

Speaker: Jia Jianxiong (Innovative Review Office of Center for Medical Device Evaluation, China Food and Drug Administration)

7. Exchanges and discussion

Contact: Zhang Tianzhen, Huang Yarong

Tel.: 010-68362389, 13391858786, 18611383567.

Fax: 010-68390734