Circular No.4 of National Drug Administration on sampling results of medical devices in 2020

In order to strengthen the quality supervision and management of medical devices and ensure the safety and effectiveness of the use of medical devices, the State Drug Administration organized quality supervision and sampling inspection of five varieties of products, such as semiconductor laser treatment machine, ultrasonic tooth cleaning equipment, and operating clothes. A total of 27 batches (sets) of products did not meet the requirements of the standard. The details are as follows:

1、 Medical device products whose items are not in accordance with the standards

（1） One semiconductor laser treatment machine: produced by sinoshow company, USA, involving emergency laser terminator, which does not meet the standard requirements.

（2） One ultrasonic dental cleaning equipment: produced by E.M.S. electronic medical systems S.A., the external marking and input power of the equipment or its components do not conform to the standard.

（3） 6 batches of surgical clothes: produced by Jilin Fran Medical Technology Co., Ltd., Jiangxi Shulan Jinhuan Medical Technology Co., Ltd., Nanchang demeikang Medical Equipment Co., Ltd., Changdong Medical Equipment Group Co., Ltd., Xinxiang Rongjun Medical Equipment Co., Ltd., and Henan Yu'an Medical Technology Development Co., Ltd., involving bursting strength dry state (key product area) The bursting strength wet state (product key area), breaking strength dry state (product key area), breaking strength wet state (product key area) and water penetration resistance (non critical area of product) do not meet the requirements of the standard.

（4） One batch of hemodialyzer: produced by Shanxi Huading Xinquan medical equipment manufacturing Co., Ltd., the clearance rate involved does not conform to the standard.

（5） 18 batches of medical absorbent cotton products: Cixi Huabao medical products industry and Trade Development Co., Ltd., Zhende medical supplies Co., Ltd., Henan Gore Medical Equipment Co., Ltd., Henan xinpiao'an High Tech Co., Ltd., Henan yadu Industrial Co., Ltd., Xinxiang Hongda Sanitary Material Co., Ltd., Xinxiang Huakang Health Material Co., Ltd., Xinxiang Huaxi Health Material Co., Ltd The company, Yixin Medical Equipment Co., Ltd., Taizhou Yonghong sanitary materials Co., Ltd., Yangzhou Yucheng Medical Equipment Co., Ltd. produced the products, which involved pH, sinking time, water absorption and surfactant, which did not meet the standard requirements.

The above sampling inspection does not meet the requirements of the standard. See the attachment for the specific conditions of the products.

2、 For the products that do not conform to the standards found in the above random inspection, the State Drug Administration has required the provincial drug supervision and Administration Department of the place where the enterprise is located to make timely administrative decisions and release them to the public in accordance with the regulations on the supervision and administration of medical devices, the measures for the supervision and administration of medical devices production, and the administrative measures for the recall of medical devices. The provincial drug supervision and Administration Department of the place where the enterprise is located shall urge the relevant 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 the medical devices, actively recall the products and publicize the recall information; urge the enterprises to find out the causes of the unqualified products as soon as possible, formulate rectification measures and make rectification in place on schedule.

It is hereby notified.

Appendix: list of products that do not conform to the national standard in sampling inspection of medical devices

State Food and Drug Administration

November 13, 2020