A training conference on promoting the high-quality development of the medical device industry in Northeast China was held in Changchun

This article is reprinted from the official website of the Jilin Provincial Drug Supervision and Administration Bureau

Original link: http://mpa.jl.gov.cn/zxfw_84842/xwlm/tpxw/202407/t20240708_8931630.html

On July 4, the Jilin Provincial Drug Administration, together with the drug administration bureaus of Inner Mongolia, Liaoning, and Heilongjiang Province (region), held a training meeting in Changchun City, Jilin Province, to promote the high-quality development of the medical device industry in Northeast China. Wang Zhexiong, Director of the Medical Device Supervision Department of the National Medical Products Administration, attended the meeting.

      Wang Zhexiong pointed out that this training session is an important measure to implement the National Medical Products Administration's support for the new round of revitalization and development in Northeast China, and a specific action to promote the high-quality development of the medical device industry in the three northeastern provinces and one region. The National Medical Products Administration continues to encourage enterprises and research institutions in the three northeastern provinces and one region to strengthen innovation and research and development of medical devices, providing "early intervention, one-company-one-policy, full-process guidance, and joint research and review" for innovative medical devices to help innovative medical devices go to market faster; continues to promote innovation in regulatory systems, mechanisms, and methods, deeply carries out actions to consolidate and enhance medical device safety, and continuously strengthens the supervision of medical device quality and safety, contributing the drug regulatory force to the high-quality development of the medical device industry and the comprehensive revitalization of the Northeast.

　　 Sun Jimin, Secretary of the Party Committee and Director of the Jilin Provincial Drug Administration, said in his speech that Jilin Province is in a critical period of building a new "464" development pattern and promoting the development of the "new pharmaceutical" industry represented by biological drugs and high-end medical devices. In accordance with the deployment requirements of the Provincial Party Committee and Provincial Government, the Jilin Provincial Drug Administration has introduced a number of policies and measures to support the high-quality development of the medical device industry in the nodal cities of the "Chang-Liao-Mei-Tong-Bai-Yan" pharmaceutical and health industry corridor; relying on the Jilin Innovation Service Station of the National Medical Products Administration's Center for Medical Device Evaluation, sub-stations have been established in Tonghua City, Changchun Economic Development Zone, Changchun New District, Meihe New District, Dongfeng County and Dunhua City to provide support and guidance, accelerating the listing process of innovative products; innovatively establishing a "director hotline" mechanism to solve enterprise difficulties in a "point-to-point" manner through video conferencing; sorting out and investigating research results and implementing a "customized" task force service mechanism to promote the transformation of scientific research results and help the medical device industry become an important force in the new breakthrough of Jilin's comprehensive revitalization.

　　The training class was conducted by senior experts selected by the Medical Device Supervision Department, the Center for Medical Device Evaluation, and the Southern Institute of the National Medical Products Administration. The training covered topics such as deepening the reform of review and approval to promote industrial innovation and development, the report and trends of China's medical device industry, key technologies and industrial development of high-performance medical devices, basic principles of medical device safety and performance, key points and common problems of medical device biological evaluation, introduction of relevant guidelines for medical device clinical evaluation, requirements and common problems of registration and declaration materials for non-powered medical devices, analysis of requirements and common problems of registration and declaration materials for in-vitro diagnostic reagents. Combining specific cases, the training involved in-depth lectures, and on-site answers to questions concerning confusion, common problems encountered during communication, and pain points and difficulties in innovative medical device R&D.

　　The attending representatives all agreed that the training had rich content, was tightly scheduled, logically sound, and focused on practical results. It was an opportunity for professional development, broadening their horizons and perspectives, and gaining valuable knowledge of policies, regulations, and professional expertise. This will enable enterprises to better conduct research and development and registration and declaration of innovative medical devices, thereby promoting sustainable and healthy development of the enterprises.

　　More than 200 people from medical device research institutions and medical device manufacturing enterprises in the three northeastern provinces and one region, as well as medical device executives and officials from relevant departments of the drug administration bureaus of Inner Mongolia, Liaoning, Jilin, and Heilongjiang Province (region) attended the meeting. (Liu Yan, Ye Yanghuan)