Legal analysis: 1, in order to strengthen the supervision and management of medical devices, to protect human health and life safety, this system is formulated. 2, the quality management department is responsible for the management of medical device recall, and other related departments to assist the quality management department to complete the related work. 3, medical device recall, refers to the medical device manufacturer in accordance with the prescribed procedures for its has been listed on the market for sale of defective a certain category, model or batch of products, to take warning, inspection, repair, re-labeling, modification and improvement of instructions, software upgrade, replacement, recovery, destruction and other ways to eliminate the defects.4. The Company shall assist the medical device manufacturer to fulfill the recall obligations, communicate and feedback the medical device recall information in a timely manner in accordance with the requirements of the recall plan, and to control and recover the defective medical devices.
Legal basis: "Regulations on the Supervision and Administration of Medical Devices"
Article 4 Local people's governments at or above the county level shall strengthen the leadership of supervision and administration of medical devices in the administrative region, organize and coordinate the supervision and administration of medical devices and the response to emergencies in the administrative region, strengthen the supervision and administration of medical devices and the construction of medical devices and the capacity for the work of medical devices safety to provide protection.
Local people's governments at or above the county level are responsible for drug supervision and management of the department is responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's governments above the county level are responsible for the supervision and management of medical devices in their respective areas of responsibility.
Article 5 The supervision and management of medical devices follow the principles of risk management, full control, scientific supervision and social **** governance.
Article VI of the state of medical devices in accordance with the degree of risk of the implementation of classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors.