On July 6, the Shanghai Food and Drug Administration issued the "Notice on the Flight Inspection of 10 Medical Device Manufacturers Such as Shanghai Oriental Shunyu Technology Co., Ltd.".
According to the notice, Shanghai Oriental Shunyu Technology Co., Ltd. and Likang Huayao Biotechnology (Shanghai) Co., Ltd. do not comply with the relevant regulations on the quality management of medical device production. In case of potential safety hazards, it should be in accordance with the Measures for the Management of Medical Device Recall. Provide for recall of related products;
Shanghai Burton Medical Equipment Co., Ltd. is suspected of producing and selling Class II medical devices in unlicensed production sites, violating the provisions of the Regulations on the Supervision and Administration of Medical Devices, and is investigated by the Pudong New Area Market Supervision Bureau and handled according to law;
Shanghai Baixiang Biotechnology Co., Ltd., Shanghai Yihua Medical Technology Co., Ltd., Kennametal Taili Metal (Shanghai) Co., Ltd. do not meet the relevant regulations of medical device production quality management regulations, and the production quality management system has serious defects;
Shanghai Fahrenheit Asia Pacific Biopharmaceutical Co., Ltd. is in suspension. Before resuming production, the enterprise shall report in writing to the Jiading District Market Supervision Bureau, and resume production after verification meets the requirements;
Shanghai Guangjian Electronic Instrument Co., Ltd. and Shanghai Fudan Zhangjiang Bio-Pharmaceutical Co., Ltd. are in a state of suspension. Before resuming production, the enterprise shall report in writing to the local market supervision bureau, and resume production after verification meets the requirements;
Shanghai Kexin Biotechnology Research Institute does not have the original production license conditions. The company applied for cancellation of the "Medical Device Manufacturing Enterprise License" on June 29, 2017.
The Shanghai Food and Drug Administration has requested the relevant market supervision bureau to urge enterprises to implement rectification according to the above-mentioned measures, severely investigate and punish violations of laws and regulations, and eliminate potential risks in time.
Attached full text
Notice of the Shanghai Food and Drug Administration on the flight inspection of 10 medical device manufacturers including Shanghai Oriental Shunyu Technology Co., Ltd. (July 6, 2017)
2017 No. 7
According to the "Measures for the Flight Inspection of Pharmaceutical Medical Devices", in conjunction with the requirements of the 2017 Medical Device Supervision Work Plan, the SIPO recently organized a flight inspection of some medical device manufacturers. The results of the inspection are as follows:
1. The flight inspection found that Shanghai Oriental Shunyu Technology Co., Ltd. and Likang Huayao Biotechnology (Shanghai) Co., Ltd. did not meet the relevant regulations on medical device production quality management regulations, and the production quality management system has serious defects (see Annex 1). The Market Supervisory Authority required it to suspend production for rectification. The enterprise shall assess the safety risks of the products and, if there is a potential safety hazard, recall the relevant products in accordance with the provisions of the “Administrative Measures for Medical Device Recallâ€. Before resuming production, the enterprise shall report to the bureau in writing, and resume production after verification meets the requirements. Likang Huayao Biotechnology (Shanghai) Co., Ltd., which was found to be in violation of the Regulations on the Supervision and Administration of Medical Devices, was investigated by the Pudong New Area Market Supervision Bureau and handled according to law.
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