China's NMPA Reports Five Cases of Illegal Medical Device Sales Online (Batch Six)
Beijing, May 31, 2024 - The National Medical Products Administration (NMPA) has reported five new cases of illegal online sales of medical devices as part of its ongoing efforts to regulate the industry. Under the guidance of the NMPA, various levels of drug regulatory authorities have intensified their monitoring of online medical device sales through the National Medical Device Network Sales Monitoring Platform. These efforts aim to detect and handle illegal activities promptly, ensuring public health and safety. Below are details of the five recent cases:
Wuhu Health Harmony Medical Device Co., Ltd.
On October 8, 2023, the Wuhu Municipal Market Supervision Administration in Anhui Province conducted an on-site inspection based on monitoring clues. It was discovered that the company had been selling Class III medical devices, specifically absorbable surgical sutures, on the Pinduoduo platform without obtaining the necessary medical device business license. This activity violated Article 42 of the Medical Device Supervision and Administration Regulation. On December 1, 2023, the Wuhu Municipal Market Supervision Administration imposed administrative penalties on the company as per Article 81 of the regulation.
Luzhou De Tang Trading Co., Ltd.
On December 6, 2023, the Jiangyang District Market Supervision Administration in Luzhou, Sichuan Province, based on network sales patrol clues, inspected the company’s premises. The findings revealed unauthorized sales of Class III medical devices, specifically contact lens care solutions, on the Meituan platform. This violated Article 42 of the Medical Device Supervision and Administration Regulation. On April 29, 2024, administrative penalties were imposed per Article 81 of the regulation.
Xuzhou Huaxia Ankang Pharmacy Chain Co., Ltd., Food City Store
On February 28, 2024, the Yunlong District Market Supervision Administration in Xuzhou, Jiangsu Province, inspected the store based on monitoring clues from the National Medical Device Network Sales Monitoring Platform. The store had been selling Class II medical devices, such as medical recombinant humanized collagen ointment, on the Ele.me platform without notifying the relevant drug supervision department and without displaying the medical device registration certificate. This violated Article 46 of the Medical Device Supervision and Administration Regulation and Article 10 of the Measures for Supervision and Administration of Online Sales of Medical Devices. On April 22, 2024, administrative penalties were imposed as per Article 89 of the regulation and Article 40 of the Measures.
Chongqing Kangbeijian Trading Co., Ltd.
On February 22, 2024, the Yuzhong District Market Supervision Administration in Chongqing inspected the company based on monitoring clues. It was found selling Class II medical devices, such as disposable sterile vaginal dilators and biofilm wound dressings, to individual consumers on the Meituan platform without proper authorization. This violated Article 10 and Article 13 of the Measures for Supervision and Administration of Online Sales of Medical Devices. On April 2, 2024, administrative penalties were imposed as per Articles 40 and 44 of the Measures.
Taian Linrui Pharmaceutical Co., Ltd.
On March 8, 2024, the Xintai Market Supervision Administration in Shandong Province inspected the company based on a complaint. The company had been selling Class II medical devices, such as portable cold light tooth whitening devices, on JD.com without displaying the medical device registration certificate. Despite being ordered to rectify the situation and given a warning, the company failed to comply. This violated Article 10 of the Measures for Supervision and Administration of Online Sales of Medical Devices. On March 27, 2024, administrative penalties were imposed as per Article 40 of the Measures.
Safety Reminder: According to the Medical Device Supervision and Administration Regulation and the Measures for Supervision and Administration of Online Sales of Medical Devices, entities engaging in online sales of medical devices must prominently display their operational licenses and medical device registration certificates or filing credentials. They must operate legally and in good faith, ensuring the quality and safety of medical devices. Third-party online medical device trading platforms must continually monitor compliance and report any violations to the relevant drug regulatory authorities promptly.
The drug regulatory authorities will continue to rigorously enforce the "four strictest" requirements, enhancing supervision, maintaining a high-pressure stance, and severely punishing illegal activities to ensure the safety of medical devices used by the public.
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