Circular of the State Food and Drug Administration on Issuing the results of national medical device supervision and random inspection (No. 5) (No. 91, 2020)
Date of issue：2021-07-03 Number of views：479次
In order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical devices, the State Drug Administration organized the sampling inspection of 11 varieties of products, including customized fixed denture, medical oxygen concentrator (medical oxygen concentrator) and specific electromagnetic wave therapeutic device. A total of 52 batches (sets) of products did not meet the standard. The details are as follows:
一、 Medical device products whose sampled items do not meet the requirements of standards
（一）Six batches of customized fixed dentures were produced by Foshan Nanhai Yahao denture Co., Ltd., Hengyang Zhengxiang Aigo denture manufacturing center, Jinan jinguanqiao denture Co., Ltd., Nanchong Chuankou denture manufacturing Co., Ltd., Zhuhai Huaguan Trading Co., Ltd. and Zhuhai Santong ceramic denture Co., Ltd. the porosity involved did not meet the standard.
（二）Three batches of abdominal puncture devices were produced by Hangzhou Tonglu Medical Optical Instrument Co., Ltd. and Zhejiang Geyi Medical Instrument Co., Ltd. respectively, and the hardness (if applicable) and matching performance did not meet the standard.
（三）1 set of high-frequency surgical equipment: produced by Shandong Yuhua Electric Co., Ltd. the sample can not be used normally during the inspection process and does not meet the standard.
（四）One batch of acetabular liner was produced by Samo S.p.A. the dimension and tolerance of joint surface did not meet the standard.
（五）3 slit lamp microscopes: produced by Suzhou Liuliu Vision Technology Co., Ltd., Xinghe Co., Ltd. and c.s.o.srl of Italy, respectively. The external marks of equipment or equipment components do not meet the requirements of the standard.
（六）One radiofrequency ablation catheter: produced by St. Jude Medical St. Juda medical supplies Co., Ltd., the DC resistance involved does not meet the standard.
（七）Two infusion pumps (injection pump, analgesia pump and insulin pump): produced by Zhejiang Medicon Medical Equipment Co., Ltd., the accuracy of audible alarm signal and working data does not meet the standard.
（八）11 sets of sleep apnea treatment equipment: DeVilbiss healthcare LLC, Respironics, Inc. Weikang Co., Ltd., somnetics International Inc., Fisher Park healthcare Co., Ltd., Guangzhou Nanbei Electronic Technology Co., Ltd., Hangzhou Yimian Medical Technology Co., Ltd., Jilin Province wohong medical device manufacturing Co., Ltd Nanjing shupusida Medical Equipment Co., Ltd., Shenyang Xinsong Medical Technology Co., Ltd. and Shenyang Xinsong Medical Technology Co., Ltd. are not in conformity with the standard in terms of external marks, operation instructions, technical instructions, maximum pressure limit and accuracy of working data of equipment or equipment components.
（九）Five specific electromagnetic wave therapeutic devices are produced by Anhui Lejin Health Technology Co., Ltd., Chengdu xinbohao Technology Co., Ltd., Henan Nanyang national defense science and Technology Industrial Electrical Research Institute, and Yingkou Weikang medical device Co., Ltd., involving external marks, indicator lights and buttons, random files, disconnection with power supply network, marks of controllers and instruments The operating parts and protective parts of power cord, indicator and controller do not meet the standard.
（十）One batch of disposable portable infusion pump was produced by Leventon s.a.u. the accuracy (flow rate) did not meet the standard.
（十一）18 sets of medical oxygen concentrators: Respironics, Inc., Respironics, Inc. Weikang Co., Ltd., Beijing Kangzhu Medical Equipment Co., Ltd., Changzhou Zhongjin Medical Equipment Co., Ltd., Fuzhou Ruikang Medical Equipment Co., Ltd., Jilin Aierkang Medical Equipment Co., Ltd., Jiangsu Fulin Medical Equipment Co., Ltd Omron (Dalian) Co., Ltd., Shanghai guanrui Medical Electronics Co., Ltd., Shenzhen xinnuozhizao Medical Co., Ltd., Shenyang AITai Technology Co., Ltd. and Shenyang Xinsong Medical Technology Co., Ltd. are involved in the production of vibration and noise, oxygen concentration, input power, marking of controller and instrument, external marking, enclosure sealing The safety, continuous leakage current and patient auxiliary current (at normal working temperature) of the cover and door that can be opened without tools do not meet the standard.
The above sampling inspection does not meet the requirements of the standard, and the specific situation of the products is shown in the annex。
二、For the above-mentioned non-conforming products found in the sampling inspection, the State Drug Administration has required the local provincial drug regulatory department to make administrative decisions in time and announce them to the public in accordance with the requirements of the regulations on the supervision and administration of medical devices, the measures for the supervision and administration of the production of medical devices, and the administrative measures for the recall of medical devices. The provincial drug regulatory department should urge the enterprises to conduct risk assessment on the products that do not meet the requirements of the standards, determine the recall level according to the severity of the defects of medical devices, actively recall the products and disclose the recall information; Supervise and urge the enterprise to find out the causes of unqualified products as soon as possible, formulate rectification measures and rectify them on schedule.
Notice is hereby given.
Annex: list of products that do not meet the requirements of the standard
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