A large number of illegal medical devices have been investigated

On December 4, the police seized a large number of high-risk three types of medical devices implanted into the body, and computer and paper account books recorded a large number of medical device distribution information. On December 1, according to CCTV news, the reporter learned from Baotou market supervision and Administration Bureau of Inner Mongolia autonomous region that a local illegal operation and storage of medical devices had been destroyed recently. 545 boxes of 34 varieties of medical devices were seized on site, including high-risk medical devices such as artificial knee joint, artificial hip joint ball head, shinbone liner, bone cement and other human implants, involving more than 15 million yuan. In this year's major inspection of potential safety hazards of medical devices in Baotou City, Baotou municipal market supervision and Administration Bureau obtained relevant clues about the black dens of medical devices. After investigation, law enforcement officers narrowed the target range to a residential area in Baotou city. More than 10 law enforcement officers went home to investigate and finally entered the suspicious house. They found that a large number of orthopedic implants and other medical devices were stored in the house, and a large number of medical device distribution information was recorded on the computer and paper account books.

According to the law enforcement personnel, orthopedic implantable medical devices are medical devices implanted into the human body as substitutes or auxiliary human organs, which are listed as the third category of medical devices with the highest risk level by the state. In accordance with Article 31 of the regulations on the supervision and administration of medical devices, it is necessary to obtain the business license of medical devices to engage in the business of class III medical devices. In addition, the code for the quality management of medical device business also stipulates that business places and warehouses shall not be located in residential areas and other places that are not suitable for business operation. Through preliminary verification, Zhou XX, the suspect involved in the case, could not provide legal business qualification. Through the investigation and verification of on-site seizure of physical objects, materials, bills, etc., the law enforcement personnel preliminarily identified the operator as suspected of operating class III medical devices without permission. At present, this case is under further investigation. According to Article 16 of the management standard for medical device operation quality, an enterprise shall have business premises and warehouses suitable for its business scope and business scale, and the area of the business premises and warehouses shall meet the business requirements. Business premises and warehouses shall not be located in residential buildings, military administrative areas (excluding leasable areas) or other places that are not suitable for business operation.