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National Medical Device Regulatory Work Conference

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February 18, 2014 to 19, the national medical device supervision and management work conference held in Beijing.

February 18, 2014 to 19, the national medical device supervision and management work conference held in Beijing. Fully implement the 2014 meeting of the National Food and Drug Management and honest government work conference to sum up 2013 national medical device regulatory work , analysis of the current situation in the supervision of medical devices , specifically 2014 national medical device regulatory work plans and priorities . Administration of Registration Department equipment and instruments Supervision Department is responsible , respectively, for 2013 registration and regulation of medical devices summarized the work of the 2014 work carried out specific arrangements . Coke Red Administration leadership , food and drug safety director attended the meeting and delivered an important speech .


Jiaohong  affirmed the outstanding results in 2013 food and drug regulatory system has made in the registration and regulation of medical devices work, objective analysis of the current situation and tasks facing the medical device regulatory work . She noted that in 2013 , the cadres and workers of medical device regulatory front, actively involved in the reform and innovation, to tackle tough , solid work . Pay close attention to outstanding issues remediation, pay close attention to improve their work style , work registration and regulation of medical devices has been greatly norms, the people with firearms safety is a strong guarantee. Currently , medical device regulatory system legal system has made important progress , review and approval mechanism reform steadily, outstanding issues remediation remarkable achievements , efforts to strengthen supervision after the listing , regulatory fruitful international cooperation . Medical device regulatory work is an important part of the food and drug supervision work in 2013 has been impressive, the annual medical equipment not found significant quality and safety incidents , the security situation is generally stable for the better .


Jiaohong says that the regulatory mechanism with the deepening of the reform of the food system drugs , food and drug supervision work ushered in a period of all-round development of the historical opportunity , golden . Party General Secretary , Comrade Zhang Yong, the Secretary has repeatedly stressed : Food and Drug Administration to open the base business is facing the task of career , a great responsibility. We should deeply understand the CPC Central Committee and the State Council, the new requirements for food and drug supervision work, and a clear understanding of the complex situation facing the supervision of medical devices , medical equipment functions correctly handle changing regulatory work ; close attention to the international trend of medical device regulation.


Jiaohong Emphasize , 2014 is the key to laying the foundation for food and drug regulatory agencies and development year for medical device regulatory work , the building will be in the system , capacity-building years . Medical device regulatory task very arduous work , establish a new system task more difficult . She asked to focus on the following seven aspects : First, seize the opportunity to reform and improve the medical device regulatory system ; Second, the main line of the revised regulations , improve medical device regulatory systems ; Third, functional transformation to adapt to the requirements and deepening medical device review and approval system reform ; fourth is a sound working mechanism , strengthen the supervision of medical devices listed ; Fifth, strengthen personnel and information technology , medical devices to enhance regulatory capacity ; six innovative regulation, regulation of medical devices to create a situation of social cohabitation ; seven are building a clean government , and establish a good image of the medical device regulatory .


Beijing , Liaoning, Shanghai , Jiangsu, Zhejiang , Henan, Guangdong and Gansu eight provinces (municipalities ) exchange bureau spoke at the meeting .


Provinces, autonomous regions and municipalities and Xinjiang Production and Construction Corps , plans to municipalities and sub-provincial capital cities Food and Drug Administration in charge of the supervision and management of medical devices and related responsible person comrades , the PLA General Logistics Department of the Ministry of Health in charge of medical equipment and Drug Administration supervision and management and leadership comrades , the relevant departments of the General Administration of organs and units directly responsible , Beijing , Tianjin Bureau of medical Devices Evaluation Center leader, Chinese medical Device industry Association attended the meeting.