41 medical equipment companies were inspected, 6 were transferred to inspection, and 7 were discontinued

Pharmaceutical Network July 13th Yesterday, Shanghai Food and Drug Administration issued a notice. In the past month, a total of 41 medical device companies were inspected, of which 6 were transferred to the inspection department and 7 were suspended for rectification.

According to the notice, in June, the Shanghai Drug Administration Department formed 22 inspection teams to conduct flight inspections on 41 medical device manufacturers in the city, involving the first, second and third types of medical devices and sterile, active, denture, reagents and other varieties. Covered 11 districts including Pudong, Minhang, Baoshan, Putuo, Jiading.

For enterprises found to be suspected of illegal or irregular activities or serious defects during the flight inspection, the Municipal Food and Drug Administration will coordinate the relevant inspection departments to assist in the investigation and evidence collection at the first time, and do a good job in the connection of flight inspection and investigation.

Flight inspection found that Shanghai Medical Bay Laser Technology Co., Ltd., Shanghai Puyi Medical Devices Co., Ltd., Shanghai Quanan Medical Devices Co., Ltd., Shengmeishen Medical Technology (Shanghai) Co., Ltd., Shanghai Cangsong Medical Devices Co., Ltd., Shanghai Gu Medical Devices Technology Co., Ltd., Shanghai Xinxin Medical Devices Co., Ltd. does not comply with the relevant regulations on medical device production quality management regulations, and the production quality management system has serious defects.

The above seven enterprises shall suspend production for rectification and evaluate product safety risks. For those who may cause safety hazards, the relevant products shall be recalled in accordance with the provisions of the “Administrative Measures for Medical Device Recall”, and the market supervision bureau of the enterprise where the enterprise is located shall supervise the implementation.

In addition, Shanghai Boxun Industrial Co., Ltd. Medical Equipment Factory, Shanghai Jianlong Health Care Products Co., Ltd., Shanghai Beite Medical Devices Co., Ltd. are suspected of violating the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, and handed over to the inspection department for investigation and handling according to law.

Also, Shanghai Hankang Medical Devices Co., Ltd., Shanghai Yuhua Medical Devices Co., Ltd., Shanghai Dingjing Bio medicine Technology Co., Ltd., Shanghai Sencai Digital Printing Materials Co., Ltd. is in a state of suspension.

Shanghai Taichang health Technology Co., Ltd. is in a state of suspension. The company took the initiative to cancel the first class on June 12, 2018. medical instruments Production record voucher.

Shanghai Yurong Medical Devices Co., Ltd., Shilong Medical Equipment (Shanghai) Co., Ltd., Shanghai Fenghui Medical Instrument Co., Ltd. have been discontinued and have no original production license conditions or are inconsistent with the filing information. enterprise If you need to continue the production of medical equipment, you should go through the procedures for change or cancellation, otherwise it will be cancelled according to law.