2016 is the start of “the thirteenth five-year plan”, so what is new in medical devices supervision? What’s the key? What responsive measures shall enterprises take? In order to provide a face-to-face communication platform for supervision department and enterprises on these questions, in the afternoon of January 27, CAMDI held a medical devices industry supervision symposium during 2015 annual meeting. Jiao Hong, deputy director of CFDA, Gao Guobiao, deputy director of Department of Medical Device Registration, Sun Lei, deputy director of Department of Medical Device Supervision, Cao Guofang, deputy director of Center for Medical Device Evaluation, Zhang Zhijun, vice-president of National Institute for Food and Drug Control (NIFDC), Li Jingli, head of Institute for Medical Device Standardization Administration, and Wang Zhigang, deputy director of CFDA Center for Administrative Services and Complaints & Reports (CFDACCR) attended the symposium. Representatives from over 10 enterprises attended the symposium, including Flon Holding Group, Siemens (China) Ltd., WOGO Holding Ltd., Medtronic (Shanghai) Management Co., Ltd. The meeting was presided by the chairman Zhao Yixin.

The theme of the symposium was the recent news of medical device supervision and enterprises’ response to the supervision change. Deputy Director Jiao Hong firstly introduced the Chinese supervision focus of medical device in 2016, including but not limited to comprehensive promotion of medical devices review & approval reform to international level, further implementation of new regulation system, full implementation of responsibilities of supervision department and enterprises, continuous improvement of supervision capacity and level to accelerate research and development innovation while controlling product risk so as to promote sound development of the industry.

It is known that in order to fully implement responsibilities, the frequency and coverage of unannounced inspection will be enhanced by supervision department and quality sampling inspection and on-site inspection of oversea manufacturing enterprises will be intensified, and verification of research and experiment will be initiated. The attended representatives, by combining with industrial development, gave some advices and suggestions in terms of registration review, supervision mode and regulations system construction and said they will learn and implement new regulations, promote quality system construction of enterprises, implement quality supervision and report responsibilities and be responsible for the authenticity of application materials.