From July 19th to July 24th, the State Food and Drug Administration will conduct flight inspections on four medical device manufacturers. The four types of products that were inspected by the companies were all sterile medical devices, of which two were in a state of suspension, and two were instructed to rectify within a time limit.
The following are the details of their respective flight inspections:
1. Rectification - Harbin Clove Medical Devices Co., Ltd.
The relevant behavior of Harbin Clove Medical Devices Co., Ltd. does not meet the relevant requirements of the quality management regulations for medical devices, and the quality management system has defects. The Heilongjiang Provincial Food and Drug Administration has instructed Harbin Clove Medical Devices Co., Ltd. to rectify the above defects within a time limit.
2. Discontinued status - Guangxi Medical Technology Medical Products Factory
On May 1, 2016, Guangxi Medical Science and Technology Medical Products Factory submitted the “Application Report for Suspension and Rectification†to the Food and Drug Administration of Guangxi Zhuang Autonomous Region and the Food and Drug Administration of Zhangzhou City. Upon verification by the inspection team, the company was in a state of suspension. Before the enterprise resumes production, it shall report in writing to the Food and Drug Administration of Guangxi Zhuang Autonomous Region in accordance with relevant regulations, and resume production after verification by the Food and Drug Administration of Guangxi Zhuang Autonomous Region.
3. Discontinuation status - Guangxi Beilunhe Medical Industry Group Co., Ltd.
Guangxi Beilunhe Medical Science and Industry Group Co., Ltd. submitted the “Discontinued Report†to the Food and Drug Administration of Guangxi Zhuang Autonomous Region on April 12, 2016. Upon verification by the inspection team, the company was in a state of suspension. Before the enterprise resumes production, it shall report in writing to the Food and Drug Administration of Guangxi Zhuang Autonomous Region in accordance with relevant regulations, and resume production after verification by the Food and Drug Administration of Guangxi Zhuang Autonomous Region.
4, rectification - Tianjin Hana Good Medical Materials Co., Ltd.
The relevant behavior of Tianjin Hana Good Medical Materials Co., Ltd. does not meet the relevant requirements of the quality management regulations for medical devices, and the quality management system has defects. It is now instructed by Tianjin Market and Quality Supervision and Management Committee that Tianjin Hana Good Medical Materials Co., Ltd. to rectify the above defects within a time limit.
Note that these 12 provincial enterprises have not been checked by flight!
In addition to the latest four companies, since March 22 this year, in the past four months, the FDA has already inspected 36 medical device manufacturers, with an average of nearly 10 flying tests per month. The density of flight inspections has never been seen before.
These 36 machinery enterprises cover 19 provinces (municipalities and autonomous regions), and there are also 12 enterprises in Shanxi, Shaanxi, Ningxia, Gansu, Xinjiang, Tibet, Qinghai, Hainan, Anhui, Hebei, Guizhou and Yunnan. , has not encountered a flight inspection. The State Food and Drug Administration has not yet opened overseas flight inspections.
However, from the information disclosed previously, the flight inspection by the FDA will not check some provinces and let go of another province. Therefore, the machinery enterprises in these 12 provinces should also encounter flight inspections in the next few months.
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