Recently, the National Medical Products Administration reported 6 cases of illegal and irregular online sales of medical devices, including the sale of Class III medical devices on the Xianyu platform by Mr. Men without permission (fifth batch). The National Medical Products Administration reminds that according to the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Operation", those engaged in medical device operation activities are not allowed to operate medical devices that have not been registered or filed in accordance with the law, have no qualification certificates, or have expired, expired, or eliminated. Medical device operating enterprises should enhance their sense of main responsibility and operate legally. Third party platform enterprises for medical device online trading services should continue to strengthen the compliance governance of online sales, strengthen monitoring and management of the business and product qualifications of medical device operators who enter the network, and promptly stop and report any illegal or irregular behavior to the local drug regulatory department. The fifth batch of illegal and irregular cases of medical device online sales: Firstly, Mr. Men sold Class III medical devices on the Xianyu platform without permission. On May 8, 2023, the Market Supervision Administration of Xiqing District, Tianjin conducted an on-site inspection of Mr. Men's address based on the monitoring clues of the National Medical Device Online Sales Monitoring Platform. After investigation, it was found that the party involved did not obtain a medical device operation license and sold the third category medical device "Tumor Electric Field Therapy Instrument" on the Xianyu platform. The above behavior violates Article 42 of the Regulations on the Supervision and Administration of Medical Devices. On August 31, 2023, the Market Supervision Administration of Xiqing District, Tianjin City imposed administrative penalties on the parties involved in accordance with Article 81 of the Regulations on the Supervision and Administration of Medical Devices. 2、 On June 8, 2023, the Market Supervision Administration of Qiaodong District, Zhangjiakou City, Hebei Province, conducted an on-site inspection of the Qiaodong Laiba Convenience Store for selling Class III medical devices on the Meituan platform without permission. After investigation, it was found that the party involved did not obtain a medical device operation license and sold the third category medical device "natural rubber latex condoms" (including benzocaine) on the Meituan platform. The above behavior violates Article 42 of the Regulations on the Supervision and Administration of Medical Devices. On August 16, 2023, the Market Supervision Administration of Qiaodong District, Zhangjiakou City imposed administrative penalties on the parties involved in accordance with Article 81 of the Regulations on the Supervision and Administration of Medical Devices. 3、 On July 14, 2023, Shenzhen Aishangpin Biotechnology Co., Ltd. conducted an on-site inspection of Shenzhen Aishangpin Biotechnology Co., Ltd. for the sale of Class II medical devices that were not registered in accordance with the law on the Kuai Tuan Tuan platform. After investigation, it was found that the parties involved in the sale of Class II medical devices "mercury thermometers" on the Kuai Tuan Tuan platform did not register them in accordance with the law, and did not establish a purchase inspection record system. The above behavior violates the provisions of Article 45 and Article 55 of the Regulations on the Supervision and Administration of Medical Devices. On September 8, 2023, the Pingshan Supervision Bureau of the Shenzhen Municipal Administration for Market Regulation imposed administrative penalties on the parties involved in accordance with Article 81 and Article 89 of the Regulations on the Supervision and Administration of Medical Devices. 4、 Hui Futang (Xiamen) Biotechnology Co., Ltd. sells unregistered Class II medical devices on Taobao platform. On May 23, 2023, the Market Supervision Administration of Jimei District, Xiamen City, Fujian Province
Edit：GuoGuo Responsible editor：FangZhiYou
Source：people.cn
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