The market regulator in Dingzhou City, Hebei Province, recently organized a three-session training program on regulations governing the medical device distribution sector for 156 local medical device enterprises. The initiative aims to enhance compliance within the industry, reinforce corporate responsibility, and ensure public safety in the use of medical devices.

The training focused on key regulations, including the "Regulations on the Supervision and Administration of Medical Devices," the "Quality Management Practices for Medical Device Distribution," the "Quality Management Practices for Online Sales of Medical Devices," and the "Measures for the Supervision and Administration of Medical Device Distribution." It highlighted common risks and典型案例 from daily oversight and enforcement actions, with detailed explanations on requirements for license management, procurement inspection, storage maintenance, sales record-keeping, online sales, and adverse event monitoring. The sessions provided on-site guidance to help companies understand and comply with legal obligations and actively fulfill their primary responsibilities.

Special attention was given to "dormant" enterprises, online sellers, and companies dealing with key products such as centralized procurement items, sterile devices, and implants. These firms were reminded of policy requirements and potential risks, and were urged to submit their 2025 self-inspection reports, conduct quality management system self-assessments, and improve internal quality control measures to maintain compliance with regulatory standards.

Moving forward, the regulator will use this training as a foundation to further strengthen corporate accountability for quality and safety, intensify supervision over medical device quality, and rigorously enforce laws against violations to safeguard public health.