China’s State Food and Drug Administration issued the “Notice on Issuing the Results of National Medical Device Supervision and Sampling Inspection (No. 2) (No. 25 in 2021)” on April 12.
In order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical device products, the China National Medical Products Administration has organized and conducted product quality supervision and sampling inspections on 9 varieties of electric wheelchairs, flexible contact lenses, and disposable nasal oxygen tubes. 55 batches (sets) of products do not meet the standard requirements. Details are as follows:
(1) 15 electric wheelchair vehicles: Hebei Ruilangde Medical Equipment Technology Group Co., Ltd., Henan Hesen Medical Equipment Co., Ltd., Jinhua Yikai Power Technology Co., Ltd., Kunshan Anmingtai Electromechanical Technology Co., Ltd., and Kunshan Jingtie Precision Automatic Equipment Co., Ltd., Shanghai Weizhiqun Electromechanical Products Co., Ltd., Wen’an County Wantong Medical Equipment Co., Ltd., Yongkang Youha Electric Co., Ltd., Zhejiang Yingluohua Rehabilitation Equipment Co., Ltd., Zhongshan Fu Shide Fitness Equipment Co., Ltd. Production, involving external markings of equipment or equipment parts, random documents, driving restraint during charging, maximum speed, braking on horizontal roads, braking on maximum safe slopes, and performance on slopes, does not meet the standard requirements.
(2) 7 batches of soft contact lenses: (Korea) POLYTOUCH CO., LTD., BESCON CO., LTD, Jilin Ruierkang Contact Lens Co., Ltd. Produced by Polytouch Co., Ltd., Chongqing Lanshi Bode Optical Technology Co., Ltd., MI CONTACT Co., Ltd. Muai Optical Co., Ltd., involving water content, back vertex power, base arc radius or given bottom The diameter of the vector height does not meet the standard requirements.
(3) One nerve and muscle stimulator: produced by Beijing Aiwosi Jiexiangyun Technology Co., Ltd., and the instruction manual does not meet the standard requirements.
(4) 6 infusion pumps (syringe pump, analgesic pump, insulin pump): Zhuhai Funia Medical Equipment Co., Ltd., Shenzhen Zhongke Microlight Medical Equipment Technology Co., Ltd., Shenzhen Aosheng Technology Co., Ltd., Produced by Beijing Xinke Huada Medical Technology Co., Ltd., Hunan Kangda Biotechnology Co., Ltd., and Changsha Dipumei Medical Technology Co., Ltd., involving samples that cannot be used normally during the inspection process, alarm requirements, audible alarm signals, audible and visual The alarm, the accuracy of the work data, and the audible instructions must precede the alarm at the end of the infusion, which does not meet the standard requirements.
(5) 1 set of optometry: produced by Shanghai Chang’e Optical Instrument Technology Co., Ltd., and the external marking of the equipment or equipment parts does not meet the standard requirements.
(6) Five batches of disposable nasal oxygen tubes: Jiangsu Kele Medical Equipment Co., Ltd., Jiangxi Fenglin Medical Technology Co., Ltd., Shijiazhuang Xidebao Medical Equipment Co., Ltd., Yantai Jintian Medical Products Co., Ltd., and Beijing Produced by Hongxiangju Technology and Trade Co., Ltd., it involves leakage, sterility, and residual ethylene oxide, which does not meet the standard requirements.
(7) Seven medical electronic thermometers: produced by Dongguan Fudakang Industrial Co., Ltd., Dongguan Haokang Electronic Technology Co., Ltd., Dongguan Xiehe Medical Device Technology Co., Ltd., and Beijing Kangzhu Medical Device Co., Ltd., involving technical specifications, Display range, resolution, maximum allowable error, repeatability, measurement completion prompt function, low and over-temperature prompt function, measurement time, memory function, automatic shutdown function, external marking of equipment or equipment parts, random files, does not meet the standard requirements.
(8) 8 medical oxygen concentrators (medical oxygen generators): Foshan Kaiya Medical Technology Co., Ltd., Huangshan Yashi Medical Equipment Co., Ltd., Hubei Yijiantang Technology Co., Ltd., and Shenyang Maisi Medical Technology Co., Ltd. Produced by the company, Danyang Hengning Medical Equipment Co., Ltd., Foshan Shunde Bonded Electronics Co., Ltd., Jiangsu Shuangsheng Medical Equipment Co., Ltd., and Jiangsu Yuyue Medical Equipment Co., Ltd., involving vibration and noise, external markings, oxygen concentration, does not meet the standard requirements.
(9) 5 intermediate frequency electrotherapy instruments: Shenyang Zhongkang Shichuang Technology Co., Ltd., Qingdao Zhonghe Medical Equipment Co., Ltd., Guangzhou Yikang Medical Equipment Industrial Co., Ltd., Xi’an Jinbairun Medical Equipment Co., Ltd., and Heilongjiang Yuqilin Technology Development Co., Ltd. Company production, involving external marking, input power, connection of equipment or equipment components-overview, does not meet the standard requirements.
Source: China State Drug Administration