Legal analysis: one of the following circumstances, by the people's government at or above the county level food and drug supervision and management department confiscate the illegal income, illegal production and operation of medical devices and tools used for the illegal production and operation of equipment, raw materials and other items; illegal production and operation of medical devices less than 10,000 yuan of the value of money, and impose a fine of 50,000 yuan of more than 100,000 yuan of the following; more than 10,000 yuan of the value of money. And impose a value of more than 10 times the amount of 20 times the following fine; the circumstances are serious, within five years will not accept the relevant responsible person and the enterprise to apply for a medical device license:
(a) the production and operation of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;
(b) unauthorized to engage in the production of the second class, the third class of medical devices activities;
(C) unauthorized to engage in Class III medical device business activities.
The first paragraph of the preceding circumstances, the circumstances are serious, by the original licensing department to revoke the medical device manufacturing license or medical device license.
Legal basis: "Chinese people's *** and the State Administrative License Law" Article 14 of the law can be set administrative license. Has not yet enacted laws, administrative regulations can set administrative licenses. If necessary, the State Council may issue 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 for the enactment of laws, or formulate its own administrative regulations.
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 the supervision and administration of medical devices in their administrative areas, organize and coordinate the supervision and administration of medical devices and the response to emergencies in their administrative areas, and strengthen the supervision and administration of medical devices and the construction of their capacity to 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 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.