[Heavy] Where are the problems: 5 medical device companies have been rectified or discontinued due to flight inspection

On July 6, the State Food and Drug Administration issued a flight inspection of five medical device manufacturers.

5 medical machinery companies were rectified or discontinued in case of flight inspection

Flight inspection of Wugang Ruifeng Medical Technology Co., Ltd.

On December 5, 2014, Wugang Ruifeng Medical Technology Co., Ltd. filed a shutdown due to serious staff turnover, loss of quality management personnel and inspection personnel. Upon verification by the inspection team, the company was shut down. Before the enterprise resumes production, it shall report in writing to Henan Food and Drug Administration in accordance with relevant regulations, and resume production after verification by the Henan Food and Drug Administration.

5 medical machinery companies were rectified or discontinued in case of flight inspection

5 medical machinery companies were rectified or discontinued in case of flight inspection

Flight inspection of Tianxinfu (Beijing) Medical Devices Co., Ltd.

The following behaviors of Tianxinfu (Beijing) Medical Devices Co., Ltd. (see table below) do not meet the relevant requirements of the quality management regulations for medical devices, and the quality management system has defects. Now the Beijing Food and Drug Administration has instructed Tianxinfu (Beijing) Medical Devices Co., Ltd. to rectify the above-mentioned defects within a time limit.

5 medical machinery companies were rectified or discontinued in case of flight inspection

5 medical machinery companies were rectified or discontinued in case of flight inspection

5 medical machinery companies were rectified or discontinued in case of flight inspection

Insufflator

ZHEJIANG SHENDASIAO MEDICAL INSTRUMENT CO.,LTD. , https://www.sdsmedtools.com