China's NMPA Reports on the Fifth Batch of Illegal Online Sales of Medical Devices
Beijing, March 27, 2024 – The National Medical Products Administration (NMPA) of China has announced a crackdown on illegal online sales of medical devices, revealing details of the fifth batch of violations. The NMPA has been guiding drug regulatory departments at all levels to enhance supervision of online medical device sales, leveraging the national medical device online sales monitoring platform to intensify monitoring and handling of illegal activities.
The recent actions taken by drug regulatory departments have led to the investigation and penalization of several cases of illegal and non-compliant sales practices, thus safeguarding public health and the safety of medical device usage. The NMPA's report highlights six notable cases:
Unauthorized Sales on Idle Fish Platform: On May 8, 2023, the Tianjin Xiqing District Market Supervision Administration inspected an individual's residence following monitoring clues from the national platform. The individual was found selling Class III medical devices without a license, leading to administrative penalties on August 31, 2023.
Unlicensed Sales on Meituan Platform: The Bridge East District Market Supervision Administration in Zhangjiakou, Hebei, discovered unlicensed sales of Class III medical devices on June 8, 2023, resulting in penalties on August 16, 2023.
Sales of Unregistered Class II Medical Devices on Kuaituantuan Platform: Shenzhen Aishangpin Biotechnology Co., Ltd. was penalized on September 8, 2023, for selling unregistered Class II medical devices without a proper purchase inspection record system.
Unregistered Class II Medical Devices Sold on Taobao: Huifutang (Xiamen) Biotechnology Co., Ltd. faced penalties on September 22, 2023, for similar violations.
Sales of Unregistered Class II Medical Devices on Suning E-buy: Hangzhou Aoqu Electronic Technology Co., Ltd. was penalized on July 28, 2023, for selling unregistered Class II medical devices without a purchase inspection record system.
Medical Device Sales on Dazhong Dianping Without Displaying Registration Certificate: Wanhe Pharmacy Chain Co., Ltd. in Qianjiang District, Chongqing, was found in violation on April 20, 2023, leading to penalties on July 18, 2023.
The NMPA emphasizes the importance of compliance with the Medical Device Supervision and Management Regulations and the Medical Device Business Supervision and Management Measures. Medical device business enterprises are urged to enhance their responsibility and operate legally. Third-party online medical device transaction service platforms are also encouraged to strengthen compliance governance, monitor the qualifications of medical device operators and their products, and promptly report illegal activities to local drug regulatory departments.
Drug regulatory departments are committed to implementing the "strictest" requirements, intensifying supervision, maintaining a high-pressure stance, and severely punishing illegal and non-compliant behaviors to ensure the safety of the public in using medical devices.
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