Notice of the State Food and Drug Administration on the Release

In order to strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical device products, the State Drug Administration organized product quality supervision and sampling of 14 varieties such as semiconductor laser therapy machines, high-frequency surgical equipment, synthetic resin teeth, and a total of 26 batches (sets) of products did not meet the standard provisions. The details are as follows:

(1) Medical device products that do not meet the standards of the sampled items

(A) A semiconductor laser therapy machine: Wuhan Love Technology Co., Ltd. produced, involved in marking does not meet the standard provisions.

(2) One carbon dioxide laser therapy machine: produced by Changchun Dimei Photoelectric Technology Co., LTD., involving the instruction manual, the output mode of the laser pulse and its time characteristics do not meet the standard provisions.

(3) 2 sets of high-frequency surgical equipment: they are respectively produced by Hangzhou Dedao Medical Equipment Technology Co., LTD and Shandong Xinhua Health Industry Co., LTD., involving control devices and instruments whose accuracy does not meet the standard provisions.

(4) Synthetic resin teeth 1 batch: Shanxi Changzhi Dental Materials Co., LTD., the size of the involved teeth does not meet the standard provisions.

(5) 1 set of endoscope cleaning sterilizer: produced by Guangzhou Meimei Medical Technology Co., LTD., involving timing devices that do not meet the standard provisions.

(6) Soft CONTACT LENS batch 1: MI GWANG CONTACT LENS CO.,LTD. Production, involving total diameter, base arc radius or vector height for a given base diameter does not conform to the standard.

(7) Nerve and muscle stimulator 1: Harbin Guoji Xiangyun Medical Equipment Co., LTD., involving the use of the manual does not meet the standard provisions.

(8) Surgical clothes 7 batches: They are produced by Jiangsu Weihu Medical Technology Co., LTD., Nanchang Huayi Medical Device Co., LTD., Nanchang Aokang Medical Device Co., LTD., Nanchang Yimin Medical Hygiene Materials Co., LTD., Sichuan Hengming Science and Technology Development Co., LTD., Weihai Hongyu Non-woven Products Co., LTD., Xinxiang Huashu Medical Device Co., LTD. Involving impermeability (non-critical area of the product), sterility, bursting strength - dry state (key area of the product), bursting strength - dry state (non-critical area of the product), bursting strength - wet state (key area of the product), resistance to microbial penetration - dry state (non-critical area of the product),

Breaking strength - dry state (product critical area), breaking strength - wet state (product critical area) do not meet the standard provisions.

(9) Sleep apnea treatment equipment 1: Suzhou Anmeng Medical Equipment Co., LTD., involving the maximum pressure limit, airflow resistance does not meet the standard provisions.

(10) Gastric washing machine 4 sets: Harbin Dapeng Medical Equipment Co., LTD., Jiangsu Keling Medical Equipment Co., LTD., Nanjing Daofen Electronics Co., LTD., Yangzhou Kaida Medical Equipment Co., LTD., involving samples in the test process can not be used normally, limited pressure, pressure change, suction conversion device, noise, input power does not meet the standard provisions.

(11) Electrocardiogram machine 2 sets: respectively for Henan cloud ECG network Technology Co., LTD., Shenzhen Bangjian Biological Medical Equipment Co., LTD., involving all electrocardiogram machines must have the function of defibrillation effect protection does not meet the standard provisions.

(12) One batch of disposable human venous blood sample collection needles, produced by Guangzhou Yangpu Medical Technology Co., LTD., involving hoses that do not meet the standard provisions.

(13) 2 sets of medium frequency electrotherapy instrument: respectively produced by Beijing Dongjiehua Medical Equipment Co., LTD., Beijing Tianchangfu Medical Equipment Manufacturing Co., LTD., involving continuous leakage current and patient auxiliary current at normal operating temperature, and input power does not meet the standard provisions.

(14) Natural latex rubber condom batch 1: marked by Shandong Yaqi Latex Technology Co., LTD., involving bursting volume and pressure do not meet the standard provisions.

See the attachment for the details of the products that do not meet the above sampling requirements.

Second, for the products found in the sampling that do not meet the standards, the State Drug Administration has required the provincial drug supervision and administration department where the enterprise is located to make a timely administrative decision and announce it 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 Medical Device Production and the Measures for the Management of Medical Device Recall. The provincial drug supervision and administration department shall urge the enterprise to carry out risk assessment on the products that do not meet the requirements of the standard, determine the recall level according to the severity of the defect of the medical device, take the initiative to recall the product and disclose the recall information; Urge the enterprise to find out the reasons for the unqualified products as soon as possible, formulate corrective measures and rectify them in place on schedule.

We hereby inform you.