Hospital medical equipment procurement system

I. The purchase of medical devices should be based on the premise of quality assurance, from fully qualified and legal enterprises. Strictly audit the medical equipment and sales staff qualification certificate. Second, the procurement of large medical equipment management 1, the use of the department according to the actual needs of the work, fill out the annual purchase plan form, large medical equipment to have a feasibility study report.

Legal basis:

"The Chinese People's **** and the State Administrative License Law," Article XIV of the law can set administrative licensing. Has not yet enacted laws, administrative regulations can set administrative licenses. If necessary, the state council may adopt the issuance of decisions to set administrative licenses. After implementation, in addition to temporary administrative licensing matters, the State Council shall promptly submit to the National People's Congress and its Standing Committee to formulate laws, or to formulate its own administrative regulations.

Regulations on the Supervision and Administration of Medical Devices

Article 4 The local people's government at or above the county level shall strengthen the supervision and management of medical devices in the administrative area of the leadership, organize and coordinate the supervision and management of medical devices and the response to emergencies within the administrative area, strengthen the supervision and management of medical devices and the construction of medical devices and the capacity-building, and provide safeguards for the safety of medical devices.

Local people's governments at or above the county level are responsible for drug supervision and management of the department responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's governments at or above the county level are responsible for the supervision and management of medical devices in their respective areas of responsibility.

Article 5 of the supervision and management of medical devices follow the principles of risk management, full control, scientific supervision, 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.