China News Service, March 27. According to news on the website of the State Food and Drug Administration on the 27th, the State Food and Drug Administration guided drug regulatory authorities at all levels to strengthen the supervision of online sales of medical devices and rely on the national medical device online sales monitoring platform to strengthen the medical device network. Sales monitoring and handling of illegal and illegal clues, and severe crackdown on illegal activities. Drug regulatory authorities at all levels took active actions to investigate and deal with a number of illegal and illegal cases to effectively protect the health of the people and the safety of equipment. Information on the fifth batch of illegal and illegal cases involving online sales of medical devices is hereby notified:
1. Men sells Class III medical devices on the Xianyu platform without permission
On May 8, 2023, the Tianjin Xiqing District Market Supervision and Administration Bureau conducted an on-site inspection of Men’s address based on monitoring clues from the National Medical Device Network Sales Monitoring Platform. After investigation, it was found that the party concerned did not obtain a medical device business license and sold the third category medical device "Tumor Electric Field Treatment Device" 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 Tianjin Xiqing District Market Supervision and Administration Bureau imposed administrative penalties on the parties in accordance with Article 81 of the "Regulations on the Supervision and Administration of Medical Devices".
2.
Laiba Laiba convenience store in Qiaodong 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 Qiaodong Laiba Laiba convenience store based on reporting clues. After investigation, the party concerned did not obtain a medical device business license and sold Class III medical devices "natural rubber latex condoms" (containing benzocaine) on the Meituan platform. The above-mentioned behavior violates Article 42 of the "Regulations on the Supervision and Administration of Medical Devices". On August 16, 2023, the Qiaodong District Market Supervision and Administration Bureau of Zhangjiakou City imposed administrative penalties on the parties in accordance with Article 81 of the "Regulations on the Supervision and Administration of Medical Devices".
3. Shenzhen Aishangpin Biotechnology Co., Ltd. sells Class II medical devices on the Kuai Tuan Tuan platform that are not registered in accordance with the law.
On July 14, 2023, the Pingshan Supervision Bureau of Shenzhen Municipal Market Supervision Administration of Guangdong Province conducted an on-site inspection of Shenzhen Aishangpin Biotechnology Co., Ltd. based on the transferred clues. After investigation, it was found that the party concerned sold the second-class medical device "mercury thermometer" on the Kuai Tuan Tuan platform without legally registering it, and did not establish a purchase inspection record system. The above-mentioned behavior violates the provisions of 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 Shenzhen Municipal Administration for Market Regulation imposed administrative penalties on the parties in accordance with Articles 81 and 89 of the "Regulations on the Supervision and Administration of Medical Devices".
4. Huifutang (Xiamen) Biotechnology Co., Ltd. sells Class II medical devices on Taobao platform that are not registered in accordance with the law
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 the reporting clues. After investigation, it was found that the party concerned sold the second-class medical device "Medical Cold Compress Patch" on Taobao platform without registering it according to law, and did not establish a purchase inspection record system. The above-mentioned behavior violates the provisions of Articles 45 and 55 of the "Regulations on the Supervision and Administration of Medical Devices". On September 22, 2023, the Jimei District Market Supervision and Administration Bureau of Xiamen City imposed administrative penalties on the parties in accordance with Articles 81 and 89 of the "Regulations on the Supervision and Administration of Medical Devices".
5. Hangzhou Aoqu Electronic Technology Co., Ltd. sold Class II medical devices on the Suning.com platform that were not registered in accordance with the law.
On May 6, 2023, the Qiantang District Market Supervision and Administration Bureau of Hangzhou City, Zhejiang Province conducted an on-site inspection of Hangzhou Aoqu Electronic Technology Co., Ltd. based on the transferred clues. After investigation, it was found that the party concerned sold the second-class medical device "pulse oximeter" on the Suning.com platform without legally registering it, and did not establish a purchase inspection record system. The above-mentioned behavior violates the provisions of Articles 45 and 55 of the "Regulations on the Supervision and Administration of Medical Devices". On July 28, 2023, the Qiantang District Market Supervision and Administration Bureau of Hangzhou City imposed administrative penalties on the parties in accordance with Articles 81 and 89 of the "Regulations on the Supervision and Administration of Medical Devices".
6. Chongqing Wanhe Pharmacy Chain Co., Ltd. Qianjiang District Xinhua West Road store sells medical devices on the Dianping platform without displaying the medical device registration certificate
On April 20, 2023, Chongqing Qianjiang District Market Supervision and Administration Bureau conducted daily supervision and inspection of Chongqing Wanhe Pharmacy Chain Co., Ltd. Qianjiang District Xinhua West Road store. After investigation, the parties involved sold Class II medical devices "medical surgical masks" and "moxibustion patches" on the Dianping platform without displaying the medical device registration certificate. The above-mentioned behavior violates Article 10 of the "Measures for the Supervision and Administration of Online Sales of Medical Devices". On July 18, 2023, the Qianjiang District Market Supervision and Administration Bureau imposed administrative penalties on the parties in accordance with Article 40 of the "Measures for the Supervision and Administration of Online Sales of Medical Devices".
Safety tips for online sales of medical devices: According to the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Operations", those engaged in medical device business activities are not allowed to operate without registration or filing in accordance with the law, without qualified certification documents, expired, invalid, Obsolete medical devices. Medical device operating companies should enhance their awareness of subject responsibility and operate legally. Third-party platform companies for medical device online trading services should continue to strengthen online sales compliance management, strengthen monitoring and management of the business qualifications and product qualifications of medical device operators entering the network, and promptly stop and report violations of laws and regulations to the local drug regulatory authorities when they are discovered.
The drug regulatory authorities will conscientiously implement the "four most stringent" requirements, intensify supervision, maintain a high-pressure posture, severely punish serious violations of laws and regulations, and ensure the safety of people's use of weapons.