Recently, the National Drug Administration issued a notice on the results of national medical device supervision and sampling. The notice shows that the National Drug Administration has organized product quality supervision and spot checks on 5 varieties of dental low-voltage electric motors and application medical devices (far infrared treatment patches, magnetic therapy patches, acupoint magnetic therapy patches), and a total of 12 batches (units) of products do not meet the standard requirements. Among the 12 batches of products that did not meet the standard requirements in this sampling, 6 batches were all adhesive medical devices, which were produced by Jiujiang Gaoke Pharmaceutical Technology Co., Ltd., Zhengzhou Zhongyuan Fuli Industry and Trade Co., Ltd., Ulanqab Qiaoshi Weiye Medical Equipment Co., Ltd., Hunan Dexi Medical Technology Co., Ltd., and Chongqing Zhengren Medical Equipment Co., Ltd, Involving the detection of "relevant drug components that cannot be detected according to the requirements of supplementary testing methods". It is understood that application products often refer to a thin, sheet-like product that uses non-woven fabrics and other materials as a backing, and applies medicinal, thermal, magnetic, and other materials with suitable substrates to the backing for skin application, producing systemic or local effects. The application products that do not contain pharmaceutical ingredients and mainly rely on physical effects are registered as medical devices. As of the time of publication, the reporter had logged into the official websites of Jiujiang High tech Pharmaceutical Technology Co., Ltd. and Zhengzhou Zhongyuan Fuli Industry and Trade Co., Ltd. and did not find any response to this incident. Among them, Zhengzhou Zhongyuan Fuli Industry and Trade Co., Ltd. has been detected for the second time this year that its products do not meet the standards. On February 2nd, the Shanxi Provincial Drug Administration issued a notice on the release of medical device supervision and sampling results, which showed that the hot compress patches (batch number: 20220302; model and specification: 80mm * 90mm/patch/bag) marked as produced by Zhongyuan Fuli did not meet the standard requirements, and the unqualified items were temperature characteristics duration. According to the "Notice", for the above-mentioned products that do not comply with the standards and regulations found in the sampling inspection, the National Drug Administration has requested the provincial drug supervision and management department where the enterprise is located to make timely administrative decisions and make them public in accordance with the requirements of the "Regulations on the Supervision and Management of Medical Devices," "Measures for the Supervision and Management of Medical Device Production," and "Measures for the Management of Medical Device Recalls. The provincial-level drug supervision and management department shall urge enterprises to conduct risk assessments on products that do not meet the standard requirements during random inspections, determine the recall level based on the severity of medical device defects, actively recall products, and publicly disclose recall information; Urge enterprises to quickly identify the causes of product nonconformities, develop corrective measures, and implement timely rectification measures.
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