Home » The 2022 “National Medical Device Safety Publicity Week” was launched in Beijing

The 2022 “National Medical Device Safety Publicity Week” was launched in Beijing

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The 2022 “National Medical Device Safety Publicity Week” was launched in Beijing

Co-management and sharing of safety equipment
2022 “National Medical Device Safety Publicity Week” launched in Beijing

On July 18, the 2022 “National Medical Device Safety Publicity Week” was launched in Beijing. The theme of this “National Medical Device Safety Publicity Week” is “Co-management and sharing of safe use of devices”. Focus on the five aspects of the new process of modernization, the new action of medical device standards and inspection, the new kinetic energy of the medical device supply side and the new wave of demand. The launching ceremony was hosted by the State Food and Drug Administration, and undertaken by China Health Media Group and Beijing Municipal Food and Drug Administration. Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, attended the event and delivered a speech.

  

Medical equipment is an important public product that improves my country’s medical level, improves people’s health and well-being, and improves people’s quality of life. The Party Central Committee and the State Council attach great importance to the safety of medicines and medical devices. General Secretary Xi Jinping has made a series of important instructions on the supervision of medicines and medical devices for many times. In accordance with the decisions and deployments of the CPC Central Committee and the State Council, the State Food and Drug Administration adheres to “the most rigorous standards, the most stringent supervision, the most severe punishments, and the most serious accountability”, and promotes the work of medical device supervision to a new level. In the past year, the State Food and Drug Administration has made new progress in the construction of regulations and systems. It has issued four regulations on medical device registration and filing management, production supervision, and operation supervision, as well as related normative documents, and basically built a regulatory system covering the entire life cycle of medical devices. The reform of the review and approval system has taken new steps, strengthened review and guidance, and promoted the high-quality development of the industry with innovative review and approval. New progress has been made in the supervision of the whole life cycle, in-depth investigation and rectification of hidden dangers in the quality and safety of medical devices, and severe crackdown on illegal and criminal acts. It has made new contributions to the prevention and control of the epidemic, accelerated the emergency approval of medical devices for epidemic prevention and control, and strengthened the quality supervision of epidemic prevention and control products, making important contributions to epidemic prevention and control in my country and the world. The regulatory system and regulatory capacity building have achieved a new leap, focusing on improving the quality of medical device standards, improving the standardization system, promoting the implementation of the unique identification system, conducting scientific research on medical device regulatory research, and actively participating in international medical device organizations.

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Xu Jinghe pointed out that the development of the medical device industry and quality supervision are inseparable from the common support of all parties in the society. Medical device supervision must adhere to scientific, legal, international and modernization, and accelerate the realization of my country’s leap from a big country in manufacturing equipment to a strong country in manufacturing equipment. First, we must promote scientific supervision. We will make every effort to promote regulatory scientific research and applications, strengthen the construction of regulatory scientific research bases and key laboratories, increase regulatory research efforts, and continue to innovate regulatory tools, standards and methods to lay the foundation for industrial innovation and development. Second, we must deepen the enforcement of laws and regulations. With the completion of the “four beams and eight pillars” of the new legal system, it is necessary to continue to publicize and popularize the laws and regulations, increase the supervision and inspection of the implementation of the laws and regulations, and effectively enhance the seriousness and authority of the implementation of the laws and regulations. The third is to strengthen quality management. Medical device registrants and filers should strengthen system construction to ensure product quality; regulatory authorities at all levels should innovate supervision methods and methods to further enhance the pertinence, targeting and effectiveness of supervision. Fourth, implement governance responsibilities. A list of registrant filer responsibilities has been issued to promote the implementation of the full life cycle quality management responsibilities of medical device registrant filers, strengthen the supervision and guidance of regulatory work, and jointly create a “one network” for national regulatory work. Fifth, we must build a co-governance pattern. Improve the governance system and governance mechanism, and form a large pattern of co-governance and sharing of medical devices with enterprise responsibility, government supervision, industry self-discipline, social coordination, public participation, media supervision, and legal protection.

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At the meeting, Wang Zhen, deputy director of the First Division of Equipment Industry of the Ministry of Industry and Information Technology, Zhang Qiang, deputy secretary-general of the Beijing Municipal People’s Government, and Qiao Jie, academician of the Chinese Academy of Engineering and executive vice president of Peking University, delivered speeches. Gan Jingzhong, Secretary of Beijing Changping District Committee, Zhao Yiwu, Chairman of Beijing Natong Technology Group Co., Ltd., and Zhao Yixin, President of China Medical Device Industry Association, delivered speeches. Relevant persons in charge of China Medical Device Industry Association, China Drug Regulatory Research Association, relevant persons in charge of relevant departments and bureaus and directly affiliated units of the State Food and Drug Administration, relevant persons in charge and staff of Beijing Municipal Food and Drug Administration, and enterprise representatives attended the launching ceremony, Anhui Province , three branch venues in Sichuan Province and Hainan Province participated online.

This “National Medical Device Safety Publicity Week” lasts for one week. Relevant departments, bureaus and directly affiliated units of the State Food and Drug Administration, as well as medical device-related industry associations, enterprises and experts will jointly participate in the event, and carry out a series of publicity activities around industrial development and achievement display. The local drug regulatory authorities will carry out various forms of popular science publicity activities during the publicity week, popularize the knowledge of safe use of medical devices, and promote the innovation and high-quality development of the medical device industry.

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