There are those violations of the following circumstances, can be responsible for the personnel personally banned from engaging in medical devices for life

"Management Regulations" provides that the state of medical devices in accordance with the risk level of implementation of classification management. Among them, 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 higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.

The Drug Administration under the State Council is responsible for the development of medical device classification rules and classification directory, and according to the production, operation and use of medical devices, timely analysis of the risk of changes in medical devices, evaluation, classification rules and classification directory adjustment.

The first class of medical devices to implement product record management, the second class, the third class of medical devices to implement product registration management. It is worth noting that, for the treatment of rare diseases, serious life-threatening diseases and no effective means of treatment and response to public **** health incidents and other urgently needed medical devices, acceptance of applications for registration of drug supervision and management departments can make conditional approval decision, and in the registration certificate of medical devices contained in the relevant matters.

The emergence of particularly significant public **** health emergencies or other serious threat to public health emergencies, the State Council health department in accordance with the prevention and control of the incident needs to put forward emergency use of medical devices proposed by the State Council drug supervision and management department of the organization agreed to the validation of the emergency use of a certain range and period.

The medical device registrant, the filing of the development, production, operation, use of the whole process of medical equipment safety, effectiveness of the responsibility according to law. Found that the production of medical devices does not meet the mandatory standards, registered or filed by the product technical requirements, or there are other defects, should immediately stop production, notify the relevant business enterprises, the use of units and consumers to stop the operation and use, recall has been listed on the sale of medical devices, take remedial action, destruction and other measures to record the relevant situation, release relevant information, and the recall and processing of medical equipment to the Supervision and management of drugs and health departments responsible for the report.

Encouragement of medical device innovation

The Regulations state that the State shall formulate medical device industry planning and policies, incorporate medical device innovation into development priorities, prioritize the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The State Council drug supervision and management department should cooperate with the relevant departments of the State Council, the implementation of the national medical device industry planning and guidance policy.

At the same time, the state to improve the medical device innovation system, support for basic and applied research in medical devices, to promote the promotion and application of new technologies in medical devices, in science and technology projects, financing, credit, bidding and procurement, medical insurance and other aspects to be supported. It supports enterprises to set up or jointly set up research institutions, encourages enterprises to cooperate with universities, research institutes and medical institutions to carry out medical device research and innovation, strengthens the protection of intellectual property rights of medical devices, and improves the capability of independent innovation of medical devices.

In addition, the state supports medical institutions to carry out clinical trials, the evaluation of clinical trial conditions and capabilities into the evaluation of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.

The regulations or a lifetime "ban"

"Management Regulations" strengthened the relevant legal responsibility, increase penalties, and improve the cost of illegal.

According to the provisions of the following circumstances, one of the following circumstances, by the drug supervision and management departments responsible for confiscating the illegal income, illegal production and operation of medical devices and tools used for illegal production and operation, equipment, raw materials and other items. These circumstances include:

(a) the production and operation of medical devices without obtaining the certificate of registration of the second class, the third class of medical devices; (b) unauthorized engagement in the second class, the third class of medical devices production activities; (c) unauthorized engagement in the third class of medical devices business activities.

Among them, the illegal production and management of medical devices less than 10,000 yuan in value, and impose a fine of 50,000 yuan more than 150,000 yuan; value of more than 10,000 yuan, and impose a fine of 15 times the amount of more than 30 times the amount of the value of the fine; the circumstances are serious, and ordered to suspend production and business, 10 years do not accept the relevant responsible person and the unit of the application for licensing of medical devices, the legal representative of the unit of the illegal, the main responsible person, the person directly responsible for supervising and the person in charge of the unit. The legal representative of the offending unit, the person in charge, directly responsible for the competent person and other responsible personnel, confiscate the illegal behavior from the unit during the income earned, and impose a fine of more than 30% of the income earned 3 times the following fine, a lifetime ban on their engagement in the production and management of medical equipment activities.