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National Video and Telephone Conference on Medical Device Supervision and Administration Held

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  • Time of issue:2020-07-14 18:42
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(Summary description)On March 27, 020, the State Food and Drug Administration held a national video and telephone conference on medical device supervision and management. The meeting deeply studied Xi Jinping’s new era socialism with Chinese characteristics and the spirit of the 19th National Congress of the Party and the Second, Third, and Fourth Plenary Sessions of the 19th CPC Central Committee. In 2019, medical device supervision work will analyze the current situation and study and deploy key tasks for 2020. Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Food and Drug Administration, attended and addressed the meeting.

National Video and Telephone Conference on Medical Device Supervision and Administration Held

(Summary description)On March 27, 020, the State Food and Drug Administration held a national video and telephone conference on medical device supervision and management. The meeting deeply studied Xi Jinping’s new era socialism with Chinese characteristics and the spirit of the 19th National Congress of the Party and the Second, Third, and Fourth Plenary Sessions of the 19th CPC Central Committee. In 2019, medical device supervision work will analyze the current situation and study and deploy key tasks for 2020. Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Food and Drug Administration, attended and addressed the meeting.

  • Categories:Company News
  • Author:
  • Origin:
  • Time of issue:2020-07-14 18:42
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On March 27, 020, the State Food and Drug Administration held a national video and telephone conference on medical device supervision and management. The meeting deeply studied Xi Jinping’s new era socialism with Chinese characteristics and the spirit of the 19th National Congress of the Party and the Second, Third, and Fourth Plenary Sessions of the 19th CPC Central Committee. In 2019, medical device supervision work will analyze the current situation and study and deploy key tasks for 2020. Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Food and Drug Administration, attended and addressed the meeting.

Xu Jinghe fully affirmed the supervision of medical devices in 2019. He pointed out that the system-wide medical device supervisory personnel earnestly implement the major decision-making arrangements of the Party Central Committee and the State Council, implement the requirements of the "four strictness", and in accordance with the unified arrangement of the National Bureau, all work has achieved new results. First, the reform of the review and approval system continued to deepen. 19 innovative products and 10 clinical urgently needed priority approval products were approved for listing, implemented electronic registration of registration, reformed clinical trial management, and expanded the pilot scope of the registrant system to 21 provinces, autonomous regions and municipalities. The second is that the regulations and standards system is becoming more and more perfect. In conjunction with the revision of the "Regulations for the Supervision and Administration of Medical Devices", the supporting regulations and normative documents were revised simultaneously, and 108 standards were revised. The consistency of my country's standards with international standards reached 90.4%. **Marking has taken an important step. Third, the level of risk management has improved significantly. Regularly conduct risk consultations, conduct national spot checks on 59 kinds of 4,467 batches of products, strengthen the monitoring of adverse events, and strengthen risk handling. Fourth, stricter supervision over the entire life cycle. Carry out aseptic and implantable product inspections and "clean the net" actions, carry out clinical trials and production quality management system inspections, inspect overseas high-risk varieties, and carry out exchanges of experience in production quality management standards of 100 enterprises. Fifth, the regulatory scientific work has achieved initial results. Establish a scientific research base for medical device supervision, identify the first batch of eight medical device key laboratories, organize and initiate an artificial intelligence device innovation cooperation platform, actively participate in IMDRF and AHWP work, and contribute Chinese wisdom to global supervision.

The meeting emphasized that 2020 will be the year of completion of the comprehensive construction of a well-off society and the "13th Five-Year Plan", and a key year for achieving the goal of a hundred-year struggle. The whole system must adhere to the fundamental requirements of "four strictness" requirements, keep the bottom line to protect the **, follow the high line to promote development, constantly improve the system and system, optimize the operating mechanism, enrich the supervision force, innovate methods and accelerate the promotion of medical devices Modernize the supervision system and supervision capacity.

The meeting deployed key tasks for medical device supervision in 2020. The first is to accelerate the construction of the regulatory legal system and capacity building. Promote the early introduction of the newly revised "Regulations" and the revision of supporting regulations and regulatory documents, creating an "upgraded version" of regulatory laws and regulations. Accelerate the construction of a standard system to promote the high-quality development of medical devices. The second is to accelerate the review and approval system and capacity building. Accelerate the review and approval of innovative products, optimize innovation and priority review and approval procedures; advance the pilot of the registrant system and make preparations for full implementation; improve clinical trial management and strengthen the management of expanded clinical trials; strengthen the management of local registration filings and organize assessments Evaluation and inspection. The third is to accelerate the risk prevention and control system and capacity building. Promote risk consultation in an all-round way and implement number management on the results of risk consultation; focus on high-value medical consumables, etc., carry out sterilization and implantation and other high-risk medical device remediation; deepen the "clean the net" action; implement penalties to people In line with industry ban requirements, strengthen the connection of execution, strengthen supervision of listing cases, and severely punish illegal and criminal acts. The fourth is to accelerate the technical support system and capacity building. Improve the construction of inspection system, strengthen the construction of key laboratories, strengthen supervision and random inspection; innovate inspection methods, increase the surpriseness and effectiveness of inspection; steadily promote the monitoring of adverse events, improve the monitoring system and information system, strengthen the construction of sentinels, and strengthen active monitoring . Fifth, accelerate the promotion of social co-governance system and capacity building. Accelerate the construction of research projects and research bases for regulatory science projects; increase international exchanges and cooperation; accelerate the promotion of smart supervision and promote the deep integration of information technology and supervision.

The meeting emphasized that it is necessary to strengthen the supervision of the listing and export quality of medical devices for epidemic prevention and control. All localities should conscientiously implement the responsibility of local supervision, effectively strengthen the supervision and inspection of anti-epidemic equipment enterprises such as in vitro diagnostic reagents, ventilators, medical protective clothing and medical masks, strictly manage the management of export sales certificates, strengthen network monitoring, and strengthen public security, customs, network The letter, communication and other relevant departments cooperated to seriously investigate and punish various violations of laws and regulations.

The relevant bureaus of the State Food and Drug Administration notified the medical device work of the prevention and control of the new coronary pneumonia epidemic situation. Five provinces (cities) in Beijing, Shanghai, Shandong, Hunan and Guangdong have made speeches through video. Comrades and related personnel from the drug supervision departments of the provinces (autonomous regions and municipalities) and the Xinjiang Production and Construction Corps and the scientific research base for medical device supervision and management of the National Bureau participated in the meetings at various branch venues. The relevant bureaus and directly affiliated units of the State Bureau, the Drug Equipment Division of the Health Bureau of the Central Military Commission Logistics Department, and the responsible comrades of relevant inspection agencies, associations, and societies attended the meeting at the main venue.

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