In the afternoon of January 27, Gao Guobiao, deputy director of Department of Medical Device Registration under CFDA, in the medical devices industry supervision seminar held by CAMDI, pointed out that the key work of medical device registration in 2016 is to innovate registration mode, complete review and approval system, especially to improve professionalization ability of registration management so as to promote the whole registration of medical devices. As for the regulations, relevant standards shall be modified and issued and all the laws and regulations about medical devices registration shall be fully managed.

Sun Lei, deputy director of Department of Medical Device Supervision, pointed out that the devices supervision in 2016 shall focus on: 1. further promotion of regulation system construction; 2. implementation of medical devices production management standard; 3. construction of prevention system; and 4. further improvement of supervision capability.

Cao Guofang, deputy director of Center for Medical Device Evaluation, pointed out that the key work of the center in 2016 is to cooperate in review and approval system reform, expand scope of review, strengthen the formulation of review guideline and intensify the external training, so as to increase the application quality and review efficiency.

Wang Zhigang, deputy director of CFDA Center for Administrative Services and Complaints & Reports (CFDACCR), said the focus of the Center in 2016 is still the implementation of administrative services reform, and the next function, as per the requirement of full coverage, high standard, profession and information, will be transferred from direct acceptance to acceptance service, and scientific and rational acceptance standard and service guideline should be set out to increase the threshold of administrative acceptance and the quality of application document.

Li Jingli, head of Institute for Medical Device Standardization Administration, National Institute for Food and Drug Control (NIFDC), pointed out that the focus of institute in 2016 is to make the standard more scientific and applicable, facilitate, guide and support the standard promotion by management, demand and scientific research.