Improve the regulatory system for medical devices | Deepen the review review and approval system reform

On March 21st, March 20th, medical website learned from the website of the State Food and Drug Administration that from 19 to 20 March 2018, the National Medical Device Supervision and Management Conference was held in Shanghai. The meeting requested that the medical device supervision in 2018. The work should adhere to the principle of “stability for progress” and the general tone of the work, and in accordance with the “four most stringent” requirements, with the aim of deepening reform as the main line, and aiming at improving the safety and security level of medical devices, the food and drug supervision “seven must adhere” work is implemented. The idea is to work hard to make the people use the machinery safer and more secure.

The meeting proposed that in 2018, we must continue to improve the supervision of medical devices. Regulation The system provides an important guarantee for the supervision of medical devices; it is necessary to deepen the reform of the review, review and approval system, and promote the high-quality development of medical devices; to strengthen the supervision of the entire life cycle of medical devices and to strictly guard against the risk of strict control; to strengthen the construction of the team and provide supervision work Talent Safeguards; It is necessary to strengthen international exchanges and improve the level of supervision of medical devices in China;

From March 19th to 20th, 2018, the National Medical Device Supervision and Management Conference was held in Shanghai. The meeting thoroughly studied Xi Jinping’s new era of socialism with Chinese characteristics and the Party’s spirit of the Nineteenth Congress, and implemented the 2018 national food and drug supervision and management. The work conference on building a clean and honest government called for summarizing the 2017 national medical device supervision and management work and deploying the key tasks for medical device supervision and management in 2018. Comrade Jiao Hong, deputy director of the General Administration of Administration, attended the meeting and delivered a speech.

The meeting pointed out that since the party’s 18th National Congress, under the strong leadership of the CPC Central Committee with Comrade Xi Jinping as the core, the nationwide medical device supervision and management work has conscientiously implemented the decision-making and deployment of the Party Central Committee and the State Council on food and drug supervision, and persisted in taking the people as the center. , Take the initiative to take the responsibility, fulfill their duties, improve the quality and safety level of medical devices, and effectively protect the safety of people’s machinery. In 2017, the reform of the examination, approval and approval system for medical devices continued to deepen, and the regulatory system for medical device supervision was further improved. The work continued to strengthen, and the international exchanges and cooperation in the supervision of medical devices achieved remarkable results.

The meeting demanded that in 2018, the supervision of medical devices should be guided by the socialist ideology of Chinese characteristics with a new era of Xi Jinping, conscientiously implement the spirit of the party's Nineteenth Congress, adhere to the people as the center, and adhere to the general principle of 'stability for progress', according to The 'four most stringent' requirements, with the goal of deepening reform as the main line and improving the safety and security level of medical devices, implemented the food and drug supervision 'seven must adhere to' work ideas, and strive to make the people use the machinery safer and more secure.

In 2018, it is necessary to continue to improve the regulatory system for medical devices and provide an important guarantee for the supervision of medical devices. It is necessary to deepen the reform of the review, review and approval system, and promote the high-quality development of medical devices. It is necessary to strengthen the supervision of the entire life cycle of medical devices and strictly prevent the risk of strict control; We must strengthen team building and provide personnel protection for supervision work. We must strengthen international exchanges and upgrade the level of medical device supervision in China. We must do a good job in building clean government and improve work style.

Beijing, Liaoning, Shanghai, Jiangsu, Fujian, Shandong and Guangdong provinces and seven provinces (autonomous regions, municipalities) and other provinces and municipalities exchanged speeches. Provinces (autonomous regions, municipalities) and Xinjiang Production and Construction Corps, plans to separate cities for food drug Representatives of regulatory agencies, representatives of relevant departments and affiliates of the General Administration of Authority, Beijing, Tianjin, Shanghai, Zhejiang medical instruments Representatives of technical review institutions and relevant inspection agencies, relevant associations, and representatives of the Institute attended the meeting.