Jiangsu Province Yizheng City Market Supervision Bureau takes three measures to promote the investigation of medical device quality and safety risks

China Quality News Network In order to strengthen the risk management of medical devices and further improve the level of quality and safety assurance, the Market Supervision Bureau of Yizheng City, Jiangsu Province has recently launched a city-wide investigation and management of hidden quality and safety risks of medical devices.

The first is to advance at a high level. The investigation and management of hidden quality and safety risks of medical devices will be the key point of medical device supervision in 2024, and will be promoted in four stages. We will also conduct publicity through WeChat, phone calls and door-to-door visits to fully mobilize the enthusiasm of enterprises to participate. At present, all 17 first-level and above medical institutions in the city have completed self-examination, and 104 operating units have completed self-examination and submitted self-inspection reports.

The second is efficient rectification. Combining key tasks, key means, and key areas, we will push forward the investigation and management of hidden risks in depth. Faced with the shortcomings of medical device companies such as weak foundation, small scale, and weak capabilities, the Yizheng City Market Supervision Bureau started from "real learning and real understanding" to effectively promote the company's "real investigation and real reform" and implement "inspection while learning, Check and correct at the same time.”

The third is to improve capabilities. Optimize the "selection and effective" measures for the inspector team, invite industry experts to join the supervision and inspection team, establish mechanisms such as "follow-up learning, pragmatic training, and cross-inspection" to continue to build and strengthen the professional drug and device supervision team. So far, 106 units operating and using in vitro diagnostic reagents, sterile and implantable products have been investigated, 271 batches of products have been inspected, and 1 case has been filed. (Zhang Fei, Market Supervision Bureau of Yizheng City, Jiangsu Province)