Not long ago, this newspaper reported the news of the "Announcement on Regulating the Operational Behavior of Medical Devices in the Field of Circulation of Medical Devices" issued by the State Food and Drug Administration. The announcement requires local food and drug supervision systems to carry out centralized rectification of illegal business operations in the field of medical device circulation. Just this month, the official website of the Food and Drug Administration has successively disclosed five flight inspection notices, ordering five companies to rectify within a time limit, which means that the rectification of the medical device industry has begun to take shape.
Announcement requirements, Beijing Fule Technology Development Co., Ltd., Honghu Taining Medical Devices Co., Ltd., Hubei Xianming Medical Devices Co., Ltd., Tianxinfu (Beijing) Medical Devices Co., Ltd., Wugang Ruifeng Medical Technology Co., Ltd., etc. 5 The home medical equipment enterprise will carry out rectification within the time limit. Our reporter's inspection notice found that the content of on-site inspection defects can be described as varied, including “supplier audit records are not providedâ€, “some items have no original inspection recordsâ€, “discovering staff to eat in the production areaâ€, and “product analysis area is temporaryâ€. Transitional rooms, poor ventilation conditions, etc.
"Actually, the rectification of the medical device industry is comprehensive, and it is not limited to the business activities in the circulation field. The Food and Drug Administration also issued the "Notice on Carrying out the Supervision and Sampling of Medical Device Clinical Trials" last month. Medical device clinical trial work has also been incorporated into the regulatory system, and foreign medical device companies will also become one of the focus of spot checks, because in the field of high-end equipment, imported products still dominate the market, so domestic and imported medical devices will usher in all-round Supervision." An industry observer told this reporter that last year, a comprehensive inventory of drug clinical trial data was carried out, and many listed companies have been planted. This year, the regulatory authorities will point to the market growth rate and clinical use. In the medical device industry with a high rate, the supervision is even worse than last year, so the industry reshuffle is inevitable.
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