From December 2 to 3, the 5th China Medical Device warning conference, jointly held by the center for drug evaluation of the State Drug Administration and China Pharmaceutical Association, was held in Beijing. With the theme of "medical device vigilance and supervision science", the conference, based on the new development trend and new achievements of medical device vigilance, gathered the frontier wisdom of medical device vigilance at home and abroad, aimed at promoting the in-depth development of medical device vigilance in China, promoting the exchange and cooperation, and mutual learning of international medical device vigilance. Xu Jinghe, deputy director of the State Food and drug administration, attended the meeting and delivered a speech.
The meeting pointed out that after nearly 20 years of development, China's medical device adverse event monitoring has achieved remarkable results, providing strong technical support for medical device supervision and public rights and interests protection. From medical device adverse event monitoring and evaluation to medical device early warning is a major change in the concept, mechanism and mode of medical device governance. In the face of the rapid development of medical device industry, it is an important task to explore the establishment and continuous improvement of medical device early warning system in the new era, new situation and new system.
Xu Jinghe stressed that it is necessary to solidly promote the implementation of "opinions on Further Strengthening the monitoring and evaluation system and capacity building of adverse drug reactions", accelerate the construction of early warning system of medical devices, further enhance the systematicness, fully coordinate the alert work of medical devices, and promote the scientific, legal and standardized operation of alert work of medical devices. It is necessary to establish the monitoring, evaluation, supervision and evaluation system of medical device adverse events, comprehensively use the supervision and inspection, evaluation, typical demonstration and other mechanisms, and implement the responsibilities of all parties. Actively integrate resources, make full use of the Internet, big data, artificial intelligence and other technical means, with the help of the scientific and technological strength and talent advantages of colleges and universities, improve the scientificity, pertinence and timeliness of medical device early warning work, scientific research institutes and medical institutions. We should scientifically grasp the international development trend, actively participate in medical device alarm cooperation mechanism and international academic exchanges, expand international vision, and contribute China's wisdom and strength.
Shen Chuanyong, director of the drug evaluation center of the State Food and drug administration, said that at present, China has established a relatively perfect adverse event monitoring and evaluation system, developed and constructed the national medical device adverse event monitoring information system, and significantly improved the ability of medical device adverse event monitoring and risk assessment. By the end of 2019, the national medical device adverse event monitoring information system has received 2.85 million reports. Up to now, more than 40 issues of medical device adverse event information announcement and more than 160 issues of medical device warning news have been released, which effectively play the role of maintaining the safety of public equipment.
The meeting pointed out that after nearly 20 years of development, China's medical device adverse event monitoring has achieved remarkable results, providing strong technical support for medical device supervision and public rights and interests protection. From medical device adverse event monitoring and evaluation to medical device early warning is a major change in the concept, mechanism and mode of medical device governance. In the face of the rapid development of medical device industry, it is an important task to explore the establishment and continuous improvement of medical device early warning system in the new era, new situation and new system.
Xu Jinghe stressed that it is necessary to solidly promote the implementation of "opinions on Further Strengthening the monitoring and evaluation system and capacity building of adverse drug reactions", accelerate the construction of early warning system of medical devices, further enhance the systematicness, fully coordinate the alert work of medical devices, and promote the scientific, legal and standardized operation of alert work of medical devices. It is necessary to establish the monitoring, evaluation, supervision and evaluation system of medical device adverse events, comprehensively use the supervision and inspection, evaluation, typical demonstration and other mechanisms, and implement the responsibilities of all parties. Actively integrate resources, make full use of the Internet, big data, artificial intelligence and other technical means, with the help of the scientific and technological strength and talent advantages of colleges and universities, improve the scientificity, pertinence and timeliness of medical device early warning work, scientific research institutes and medical institutions. We should scientifically grasp the international development trend, actively participate in medical device alarm cooperation mechanism and international academic exchanges, expand international vision, and contribute China's wisdom and strength.
Shen Chuanyong, director of the drug evaluation center of the State Food and drug administration, said that at present, China has established a relatively perfect adverse event monitoring and evaluation system, developed and constructed the national medical device adverse event monitoring information system, and significantly improved the ability of medical device adverse event monitoring and risk assessment. By the end of 2019, the national medical device adverse event monitoring information system has received 2.85 million reports. Up to now, more than 40 issues of medical device adverse event information announcement and more than 160 issues of medical device warning news have been released, which effectively play the role of maintaining the safety of public equipment.