The National Medical Device Safety Publicity Week event and the launch ceremony of the National Audit and Inspection Center's training base (medical device direction) were held in Suzhou Industrial Park today.
This event was jointly held by the National Center for Drug and Medical Device Audit and Inspection, the Jiangsu Provincial Drug Administration, and the Suzhou Municipal Market Supervision Bureau. It aims to comprehensively strengthen the construction of national drug supervision training bases, highlight the simulated practical training of inspection work, promote communication and cooperation, information sharing, and complementary advantages between regulatory personnel and enterprises, create an integrated education and training system of research, training, and drills, and provide strong support for promoting the high-quality development of the pharmaceutical industry.
During the event, the first national-level medical device inspector training base was unveiled and settled in the park, and the first training class for national medical device inspectors in the first batch of training base cooperation units was officially launched.
Wang Xiaogang, director of the National Audit and Inspection Center; Wang Shucai, first-level inspector and deputy director of the Medical Device Supervision Department of the National Medical Products Administration; Yang Zhiping, deputy mayor of Suzhou; Lin Xiaoming, deputy secretary of the Party Working Committee and director of the Management Committee of Suzhou Industrial Park; Yu Wei, secretary of the Party group and director of the Suzhou Municipal Market Supervision Bureau; and Lu Yuan, member of the Party Working Committee and deputy director of the Management Committee of the park, attended the event.
Medical devices belong to a special industry with multidisciplinary crossovers and intensive technology. Their use directly relates to the physical health and safety of the people. Therefore, it is necessary to accelerate the construction of a safe and scientific regulatory system and establish a high-quality, professional, and specialized regulatory team.
"As the main force in cadre education and training and empowering the development of the park, the Suzhou Industrial Park Training Management Center has a high level of full-chain and standardized training management for training bases and has industry-leading enterprises and professional resources in industrial training, including medical devices, which can provide inspectors with systematic training to improve their comprehensive quality." Wang Xiaogang said in his speech.It is hoped that the park will further improve its teacher management, training methods, and risk management system, work hand in hand with the audit center to build a first-class medical device training base, further build an integrated education and training mechanism of teaching, learning, practice, and inspection, comprehensively improve the ability level of inspectors, and actively contribute to the high-quality development of the medical device industry.
Tianchen International Medical Technology Co., Ltd. is one of the first 14 cooperative units of the training base. After more than 10 years of development, it has become a leading enterprise in the subdivision field of high-end medical devices. Chen Wangdong, general manager of the company, believes that the establishment of the training base not only improves the level of supervision at the government level, but also promotes the improvement of enterprises' quality and risk management capabilities and comprehensive competitiveness, enabling enterprises to gain stronger capabilities and compete with multinational companies on a larger international stage.
It is reported that in the two-day training class, nearly 50 personnel from 16 inspection institutions across the country will conduct in-depth exchanges and discussions on the capacity building of medical device inspectors, and conduct on-site training at Suzhou MicroPort Orthopedics (Group) Co., Ltd. and Roche Diagnostics Products (Suzhou) Co., Ltd.
Wang Shucai said in his opening speech that the training base will provide inspectors with a good immersive practical experience platform. The completion of the training base will surely play a positive role in promoting the construction of a professional and specialized team of medical device inspectors and have a positive impact. It is hoped that the Suzhou Medical Device Training Base will give full play to its platform advantages, highlight the pertinence and effectiveness of the training work, and comprehensively improve the ability level of inspectors.
In recent years, new technologies and products have continuously emerged in the medical device industry in the park. By the end of June this year, the park has gathered nearly 500 medical device enterprises, with a total of more than 830 Class II and Class III medical device registration certificates approved, and 16 innovative medical device products have entered the special approval green channel. The development of the industry has entered the "fast lane".
In the next step, the park will always adhere to the business-friendly service concept, focus on the development needs of enterprises, provide a better development environment for more domestic and foreign enterprises, further strengthen cooperation with leaders, experts, and entrepreneurs in the biopharmaceutical field, and work together to create a better future.
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