The new version of "medical device supervision and management regulations" -- encourage innovation and strengthen supervision


Release time:

2024-03-14

On March 18, the official website of the State Food and Drug Administration issued the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"). The "Administrative Regulations" clearly stated that the state formulates medical device industry plans and policies, incorporates 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 of the medical device industry. development.

On March 18, the official website of the State Food and Drug Administration issued the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"). The "Administrative Regulations" clearly stated that the state formulates medical device industry plans and policies, incorporates 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 of the medical device industry. development.

新版《医疗器械监督管理条例》——鼓励创新 加强监管

At the same time, the state has improved the medical device innovation system, supported the basic research and applied research of medical devices, promoted the promotion and application of new medical device technologies, and supported the establishment of scientific and technological projects, financing, credit, bidding and procurement, and medical insurance. Support enterprises to set up or jointly set up research and development institutions, encourage enterprises to cooperate with institutions of higher learning, scientific 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 ability of independent innovation of medical devices. In addition, units and individuals that have made outstanding contributions to the research and innovation of medical devices will be commended and rewarded in accordance with relevant national regulations.
 
Compared with the previous "Administrative Regulations", the new "Administrative Regulations" pointed out that medical device registrants and filers should strengthen the quality management of the entire life cycle of medical devices, and be responsible for the safety and safety of medical devices in the entire process of development, production, operation, and use. Effectiveness is responsible in accordance with the law. The "Administrative Regulations" mentioned that the obligations of medical device registrants and filers include: establishing a quality management system compatible with the product and maintaining effective operation; formulating post-marketing research and risk control plans and ensuring effective implementation; carrying out adverse events in accordance with the law Monitoring and re-evaluation; establishing and implementing a product traceability and recall system; other obligations stipulated by the drug regulatory authority under the State Council.
 
In terms of submitting materials, medical device registration applicants and filers shall ensure that the submitted materials are legal, true, accurate, complete and traceable. In terms of clinical trials, the state supports medical institutions to carry out clinical trials, incorporates clinical trial conditions and capacity evaluation into the grade review of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.
 
In the production of medical devices, medical device registrants and filers may produce medical devices by themselves, or they may entrust enterprises that meet the provisions of these regulations and have the corresponding conditions to produce medical devices. However, implantable medical devices with high risk shall not be commissioned for production, and the specific catalogue shall be formulated, adjusted and published by the drug regulatory department of the State Council.
 
The "Administrative Regulations" also mentioned that the state implements the unique identification system of medical devices step by step according to the product categories of medical devices to realize the traceability of medical devices. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council. In addition, medical device users shall properly preserve the original data on the purchase of Class III medical devices and ensure that the information is traceable. Where large-scale medical devices and implanted and interventional medical devices are used, the name of the medical device, key technical parameters and other information, as well as necessary information closely related to the quality and safety of use, shall be recorded in the medical records and other relevant records.
 
Offending these regulations or being "banned" for life"
 
The "Management Regulations" strengthen relevant legal responsibilities, increase penalties, and increase the cost of violations.
 
According to the regulations, under any of the following circumstances, the department in charge of drug supervision and administration shall confiscate illegal income, medical devices produced and operated illegally, and tools, equipment, raw materials and other articles used in illegal production and operation. These situations include:
 
(I) the production and operation of Class II and Class III medical devices that have not obtained a medical device registration certificate; (II) engage in Class II and Class III medical device production activities without permission; (III) engage in Class III medical device business activities without permission.
 
Among them, if the value of medical devices illegally produced and operated is less than 10000 yuan, a fine of 50000 yuan to 150000 yuan shall be imposed; if the value of the goods is more than 10000 yuan, a fine of 15 times to 30 times the value of the goods shall be imposed; if the circumstances are serious, it shall be ordered to suspend production and business, and the medical device license application submitted by the relevant responsible person and the unit shall not be accepted within 10 years, the legal representative, the main person in charge, the directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated of the income obtained from the unit during the occurrence of the illegal act, and a fine of 30% to 3 times the income shall be imposed, and they shall be prohibited from engaging in medical equipment production and operation activities for life.

















 

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