People's Daily Online, Beijing, March 28 (Reporter Sun Hongli) - Recently, the National Medical Products Administration (NMPA) reported information on six cases of illegal online sales of medical devices, including the sale of Class III medical devices by a person surnamed Men without permission on the Xianyu platform (the fifth batch).

The National Medical Products Administration (NMPA) reminds that, in accordance with 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 shall not operate medical devices that have not been legally registered or filed, lack qualified certification documents, or have expired, become ineffective, or been eliminated. Medical device operation enterprises should enhance their sense of responsibility as the main body and operate legally. Third-party platform enterprises providing online transaction services for medical devices shall continuously strengthen compliance governance for online sales, enhance monitoring and management of the business qualifications and product qualifications of medical device operators on the platform, and promptly stop and report any violations to the local drug regulatory authorities once discovered.

The fifth batch of cases involving illegal and irregular online sales of medical devices:

1. Mr. Men sold Class III medical devices on the Xianyu platform without permission

On May 8, 2023, the Market Supervision and Administration Bureau of Xiqing District, Tianjin, conducted an on-site inspection at the residence of a person surnamed Men based on the monitoring clues from the national medical device online sales monitoring platform. Upon investigation, it was found that the party concerned had not obtained a medical device business license and was selling Class III medical devices, namely "tumor electric field therapy device," on the Xianyu platform. The aforementioned behavior violated Article 42 of the Regulations on the Supervision and Administration of Medical Devices. On August 31, 2023, the Market Supervision and Administration Bureau of Xiqing District, Tianjin, imposed administrative penalties on the party concerned in accordance with Article 81 of the Regulations on the Supervision and Administration of Medical Devices.

II. Qiaodong Lai Bailai Convenience Store sold Class III medical devices on the Meituan platform without permission

On June 8, 2023, the Market Supervision and Administration Bureau of Qiaodong District, Zhangjiakou City, Hebei Province, conducted an on-site inspection of the Qiaodong Laibailailai Convenience Store based on reported clues. Upon investigation, it was found that the party concerned had not obtained a medical device business license and sold Class III medical devices, namely "natural rubber latex condoms" (containing benzocaine), on the Meituan platform. The aforementioned behavior violated Article 42 of the Regulations on the Supervision and Administration of Medical Devices. On August 16, 2023, the Market Supervision and Administration Bureau of Qiaodong District, Zhangjiakou City, imposed administrative penalties on the party concerned in accordance with Article 81 of the Regulations on the Supervision and Administration of Medical Devices.

III. Shenzhen Aishangpin Biotechnology Co., Ltd. sold Class II medical devices on the KuaiTuan platform without proper registration

On July 14, 2023, the Pingshan Supervision Bureau of the Market Supervision and Administration Bureau of Shenzhen, Guangdong Province, conducted an on-site inspection of Shenzhen Aishangpin Biotechnology Co., Ltd. based on transferred clues. Upon investigation, it was found that the party concerned had sold unregistered Class II medical devices, "mercury thermometers," on the Kuaishou platform without establishing a system for checking and recording the purchase of goods. The aforementioned behavior violated Articles 45 and 55 of the Regulations on the Supervision and Administration of Medical Devices. On September 8, 2023, the Pingshan Supervision Bureau of the Market Supervision and Administration Bureau of Shenzhen imposed administrative penalties on the party concerned in accordance with Articles 81 and 89 of the Regulations on the Supervision and Administration of Medical Devices.

IV. Huifutang (Xiamen) Biotechnology Co., Ltd. sold Class II medical devices on the Taobao platform without legal registration

On May 23, 2023, the Market Supervision and Administration Bureau of Jimei District, Xiamen City, Fujian Province, conducted an on-site inspection of Huifutang (Xiamen) Biotechnology Co., Ltd. based on reported clues. Upon investigation, it was found that the party concerned had sold "medical cold compress patches," a Class II medical device that had not been legally registered, on the Taobao platform and had not established a system for inspecting and recording product purchases. The aforementioned actions violated Articles 45 and 55 of the Regulations on the Supervision and Administration of Medical Devices. On September 22, 2023, the Market Supervision and Administration Bureau of Jimei District, Xiamen City, imposed administrative penalties on the party concerned in accordance with Articles 81 and 89 of the Regulations on the Supervision and Administration of Medical Devices.

V. Hangzhou Auqoo Electronic Technology Co., Ltd. sold Class II medical devices on the Suning.com platform without legal registration

On May 6, 2023, the Market Supervision and Administration Bureau of Qiantang District, Hangzhou City, Zhejiang Province, conducted an on-site inspection of Hangzhou Auqiu Electronic Technology Co., Ltd. based on transferred clues. Upon investigation, it was found that the party concerned had sold the "pulse oximeter," a Class II medical device that had not been legally registered, on the Suning.com platform and had not established a system for checking and recording product purchases. The aforementioned actions violated Articles 45 and 55 of the Regulations on the Supervision and Administration of Medical Devices. On July 28, 2023, the Market Supervision and Administration Bureau of Qiantang District, Hangzhou City, imposed administrative penalties on the party concerned in accordance with Articles 81 and 89 of the Regulations on the Supervision and Administration of Medical Devices.

VI. The Xinhua West Road store of Chongqing Wanhe Pharmacy Chain Co., Ltd. in Qianjiang District sells medical devices on the Dianping platform without displaying the medical device registration certificate

On April 20, 2023, the Market Supervision and Administration Bureau of Qianjiang District, Chongqing conducted a routine supervision and inspection of the Xinhua West Road store of Wanhe Pharmacy Chain Co., Ltd. in Qianjiang District, Chongqing. Upon investigation, it was found that the party concerned sold Class II medical devices, namely "medical surgical masks" and "moxibustion patches," on the Dianping platform without displaying the medical device registration certificate. The aforementioned behavior violated Article 10 of the "Regulations on the Supervision and Administration of Online Sales of Medical Devices." On July 18, 2023, the Market Supervision and Administration Bureau of Qianjiang District imposed administrative penalties on the party concerned in accordance with Article 40 of the "Regulations on the Supervision and Administration of Online Sales of Medical Devices.".