The drug supervision and administration department of the State Council is responsible for formulating the classification rules and catalogues of medical devices, analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification rules and catalogues.
The first category of medical devices shall be subject to product filing management, and the second and third categories of medical devices shall be subject to product registration management. It is worth noting that the pharmaceutical supervisory and administrative department that accepts the application for registration can make a conditional approval decision on medical devices used to treat rare diseases, diseases that are seriously life-threatening and have no effective treatment methods, and medical devices that are urgently needed to deal with public health emergencies, and specify relevant matters in the medical device registration certificate.
In the event of particularly serious public health emergencies or other emergencies that seriously threaten public health, the health authorities in the State Council put forward suggestions for emergency use of medical devices according to the needs of preventing and controlling incidents, which can be used urgently within a certain scope and time limit after being approved by the drug supervision and administration department in the State Council.
Medical device registrants and filers shall be responsible for the safety and effectiveness of the whole process of research and development, production, operation and use of medical devices according to law. If it is found that the medical devices produced do not meet the mandatory standards, the technical requirements of registered or filed products, or there are other defects, it shall immediately stop production, notify the relevant operating enterprises, users and consumers to stop operating and using, recall the medical devices that have been put on the market, take remedial and destruction measures, record relevant information, release relevant information, and report the recall and handling of medical devices to the departments responsible for drug supervision and administration and the competent health department.
Encourage medical device innovation.
The "Regulations on Administration" points out that the state formulates plans and policies for the medical device industry, puts medical device innovation into the development focus, gives priority to the review and approval of innovative medical devices, supports the clinical promotion and use of innovative medical devices, and promotes the high-quality development of the medical device industry. The drug supervision and administration department of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and guiding policies.
At the same time, the state improves the innovation system of medical devices, supports basic research and applied research of medical devices, promotes the popularization and application of new technologies of medical devices, and gives support in scientific and technological projects, financing, credit, bidding and procurement, and medical insurance. Support enterprises to set up or jointly set up research institutions, encourage enterprises to cooperate with universities, research institutes and medical institutions to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the independent innovation ability of medical devices.
In addition, the state supports medical institutions to carry out clinical trials, integrates the evaluation of clinical trial conditions and capabilities into the grade evaluation of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.
Violation of these regulations may be banned for life.
The "Regulations on Administration" strengthened relevant legal responsibilities, increased penalties and increased illegal costs.
According to the regulations, under any of the following circumstances, the pharmaceutical supervisory and administrative department shall confiscate the illegal income, medical devices illegally produced and operated, and tools, equipment, raw materials and other items used for illegal production and operation. These situations include:
(a) the production and operation of Class II and Class III medical devices that have not obtained the medical device registration certificate; (2) engaging in the production of Class II and Class III medical devices without permission; (3) engaging in the business activities of Class III medical devices without permission.
Among them, if the value of illegally produced and operated medical devices is less than 6,543,800 yuan, a fine of 50,000 yuan to 6,543,800 yuan shall be imposed; If the value of the goods is more than 10000 yuan, a fine of more than 15 times and less than 30 times shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business, and the application for medical device license put forward by relevant responsible persons and units shall not be accepted within 10 years. The legal representative, principal responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated, and the income obtained during the illegal act of the unit shall be fined more than 30% and less than 3 times, and the production and operation of medical devices shall be banned for life.