Medical device clinical trial organization to implement the administrative license management right

Yes, the State Council executive meeting to consider the adoption of the non-administrative licensing approval of the cleanup of the work of the views of the large-scale medical equipment configuration approval from the non-administrative licensing approval of matters adjusted to administrative licensing matters, to further standardize and strengthen the configuration of large-scale medical equipment, the use of management, to protect the quality of medical care and safety, and to promote the rational allocation of health care resources.

Legal basis:

"The Chinese People's **** and the State Administrative License Law," Article 14 of the law can set administrative license. If the law has not yet been enacted, administrative regulations may set administrative licenses. If necessary, the state council may adopt the issuance of decisions to set administrative licenses. After implementation, except for 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 leadership of the supervision and administration of medical devices in the administrative area, organize and coordinate the supervision and administration of medical devices and the response to emergencies within the administrative area, and strengthen the supervision and administration of medical devices and the construction of medical devices and the ability to provide protection 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 is 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.