Seminar on Medical Devices Innovation & Development Held in Beijing

  • 2016-07-31

ON July 22, 2016, the seminar on Medical Device Innovation & Development was held by CFDA and Chinese Society of Biomedical Engineering jointly in Beijing, concentrating on the dynamics of medical device innovation and development, researching and encouraging medical device innovation policies. Jiao Hong, deputy director of China Food and Drug Administration attended the seminar and made a speech, stating that the medical device innovation was characterized by the mutual support of innovative chain, industrial chain, capital chain and policy chain. In recent years, CFDA has been completing the laws and regulations for medical device, actively promoting the review & approval policy reform, enhancing the policy support to innovative products and it issued the Special Approval Procedure on China's Innovative Medical Devices, offering a green channel for innovative products. The Priority Approval Procedure on China's Innovative Medical Devices is under formulation, planning to offer a prior approval channel for the products listed in national key S&T Special Projects or national key R&D plan and the products urgent for clinical application. It is another clinical demands-oriented major initiative to encourage medical device innovation.

Jiao Hong highlighted the CFDA’s high attention to construction of technical support to medical device, the cooperation with associations, key universities and scientific research institutions to put up a communication platform for academic organization, enterprises and governments, and pointed that the seminar is a beneficial exploration and attempt.

In the meeting, Academician Cao Xuetao, president of Chinese Society of Biomedical Engineering made a special report on the development and innovation of medical technology, and Wang Zhexiong, head of Device Registration Department introduced the latest development of the registration of medical devices. Academician Hu Shengshou, Academician Gu Xiaosong and Prof. Li Wei made guidance speeches in terms of cardiovascular diagnosis device innovation and clinical progress, tissue engineering technology innovation & development, medical device clinical trial & evaluation, respectively, and invited supervisors, clinical experts and enterprise representatives to made discussion as guests.

The participants of the meeting include tens of experts and scholars from the Chinese Society of Biomedical Engineering, enterprise representatives, responsible persons from Device Registration Department, Device Supervision Department, Center for Medical Device Standard Management, Center for Food and Drug Inspection, Center for Drug Reevaluation, Center for Medical Device Evaluation of CFDA and related personnel.

Search