For medical devices, the state requires not only price reduction, but also quality

Yesterday, the State Drug Administration (hereinafter referred to as the State Administration) issued the notice on expanding the pilot work of medical device registrant system (gymx [2019] No 33, hereinafter referred to as the notice), further expanding the pilot of medical device registrant system, and further accumulating experience for the full implementation of medical device registrant system According to the notice, 21 provinces, autonomous regions and municipalities directly under the central government, including Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan and Shaanxi, participated in the pilot of the medical device registration system In the notice, the registrant and the entrusted production enterprise participating in the pilot work are respectively provided with corresponding conditions and obligations and responsibilities, and it is clear that both parties shall sign the entrustment contract and quality agreement, and the procedures for product registration, change and production enterprise license handling are specified At the same time, it is emphasized that the drug regulatory authorities at all levels should strengthen the performance of the registrant to ensure the quality of medical devices and their listing Supervision and management of sales and service, monitoring and evaluation of adverse events of medical devices, recall of medical devices and other obligations For the entrusted production involving cross regions, the relevant provincial drug regulatory authorities shall, on the basis of coordination, determine the responsibility division of cross regional regulatory parties, implement the main body of daily regulatory responsibility, and ensure that there is no gap and dead corner in the whole life cycle of medical devices The National Bureau expanded the pilot work of medical device registrant system, which aims to further explore the establishment of medical device registrant system and entrusted production management system, optimize the allocation of resources, and implement the main responsibility; explore the establishment of a perfect medical device quality management system for registrants, and clarify the legal relationship between medical device registrants, trustees and other main bodies, with clear responsibilities On the basis of controllable risks, we should establish a quality management system and system for the registrant's whole life cycle; explore and innovate the supervision mode of medical devices, effectively implement the requirements of "supervision must keep pace with", further release the industrial vitality, promote the high-quality development of medical device industry, and meet the people's demand for using high-level medical devices It can be seen that the handling of medical devices by the state is not only the price reduction promoted by various policies While the price reduction, it is also necessary to urge enterprises to guarantee the quality of devices In the face of the problems such as unclear legal relationship between the former registrants, trustees and other subjects, 21 provinces and cities may be able to pilot the medical device registrant system Fundamentally solve the problem of unclear responsible person, but with the development of the work, I believe that the later stage of national supervision will turn to prevention This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.