Jiangsu Provincial Drug Administration announcement: there are 7 non-conforming equipment enterprises to stop production and rectification

Finishing: Chocolate a number of machinery enterprises stop production and rectification November 17, Jiangsu Provincial Drug Administration issued "on some medical device manufacturers stop production and rectification of the announcement."
The above-mentioned announcement shows that, in accordance with the Regulations on The Supervision and Administration of Medical Devices and the Regulations on Quality Management of The Production of Medical Devices, the Jiangsu Provincial Drug Administration conducted flight inspections of 32 medical device manufacturers from August 24 to September 30, 2020 for the existence of quality testing failures, adverse events and complaints, failure to conduct self-examination of the quality system or self-examination of zero defects, poor operation of the quality system, etc.
After inspection and risk meeting, will stop production and rectification of the seven enterprises announced as follows: Nanjing Yitebo Medical Technology Development Co., Ltd., Nanjing Rongyan Medical Devices Co., Ltd., Jiangsu Qilikang Skin Pharmaceutical Co., Ltd., Changzhou City Huichun Medical Equipment Co., Ltd., Xuzhou Wei materials Health Materials Co., Ltd., such as Baikang Medical Equipment Co., Ltd., Taizhou City Baikangmi Antibacterial Products Co., Ltd.
According to incomplete statistics of Cypress Blue equipment, Jiangsu Provincial Drug Administration has issued six medical device manufacturers stop production and rectification announcement, of which: June 2019 announcement shows that there are 2 arms enterprises stop production and rectification; More than
non-compliant products in addition to machinery enterprises to stop production, recently, the Jiangsu Provincial Drug Administration also issued the Jiangsu Province Medical Devices State Pumping Notice (No. 8 of 2019) disposal summary table.
The above summary table shows that Yangzhou Yucheng Medical Devices Co., Ltd., Suzhou City McLean Medical Device Products Co., Ltd., Yangzhou Yurun Technology Development Co., Ltd. and other equipment products in the national pumping there are non-compliance with the standard provisions.
relevant regulatory authorities have imposed confiscation of products, fines and other penalties on the above-mentioned enterprises in accordance with the circumstances.
Such as Yangzhou City Yucheng Medical Devices Co. , Ltd. medical degreased cotton ball surfactant substances do not meet the standard provisions, the result of the punishment is the confiscation of medical skimmed cotton ball (2g sterilization type, production lot number: 20190320) 900 bags, and a fine of 30,000 yuan, the specific situation is as follows: drawing: medical device dealers union original title: Drug Administration: these enterprises stop production and rectification