The first is to clarify the definitions of medical device registrant and applicant. Enterprises and research institutions that have obtained medical device registration certificates or gone through filing procedures are registrants and filers, and are responsible for the safety and effectiveness of the whole process of medical device research, production, management and use according to law. The second is to clarify the obligations of the registrant and the applicant. Refine the whole process management obligations, including establishing and effectively operating the quality management system, conducting post-marketing research and risk control, monitoring and re-evaluating adverse events, and establishing and implementing the product traceability and recall system. The third is to clarify the rights and obligations of registrants, filers, commissioned production enterprises, e-commerce platform operators, users and other market entities.
Five, the "Regulations" in optimizing the business environment and promoting industrial innovation.
In order to implement the reform requirements of "decentralization, strengthening supervision and improving services", further reduce the burden on enterprises and promote the high-quality development of the industry, the Regulations mainly stipulate the following systems:
First, medical device innovation will be included in the development focus, the innovation system will be improved, and support will be given in scientific and technological projects, financing, credit, bidding and procurement, and medical insurance. , so as to improve the ability of independent innovation. The second is to strengthen the informatization construction of medical device supervision and management, improve the level of online government services, and facilitate the administrative licensing and filing of medical devices. The third is to optimize the examination and approval procedures, reduce examination and approval materials, and allow enterprises to submit self-inspection reports. The fourth is to optimize the filing procedures and implement information filing and parallel filing. Fifth, medical devices that are urgently needed for the treatment of rare diseases, diseases that are seriously life-threatening and have no effective treatment methods, public health incidents, etc. can be conditionally approved for listing and accelerated. Sixth, the implementation of registration renewal and implied permission of clinical trials. Seventh, shorten the review period of production and business license from 30 working days to 20 working days. The eighth is to clarify the situation of exemption from clinical evaluation and improve the efficiency of enterprise registration application. Nine is to encourage medical institutions to carry out clinical trials and incorporate the evaluation of clinical trial conditions and capabilities into the grade evaluation of medical institutions. Ten is to allow the extension of clinical trials. Eligible medical devices undergoing clinical trials can be used for other patients with the same condition free of charge, and their safety data can be used for medical device registration application.
Six, in response to public health emergencies, the "Regulations" made the following special institutional arrangements.
In order to meet the needs of dealing with major public health emergencies and accelerate the use of urgently needed medical devices, the Regulations stipulate the following systems:
First, give priority to the examination and approval system. Give priority to the review and approval of innovative medical devices. The second is the conditional approval system. Conditional approval can be given to medical devices that are urgently needed to treat rare diseases, diseases that are seriously life-threatening and have no effective treatment methods, and public health incidents, so as to speed up the market. The third is the emergency use system. With reference to the Vaccine Management Law, it is stipulated that medical devices can be used urgently within a certain range and time limit in the event of particularly serious public health emergencies or other emergencies that seriously threaten public health. Fourthly, a special introduction system is urgently needed in clinic. It is stipulated that medical institutions urgently need to import a small amount of Class II and Class III medical devices due to clinical needs, and they can import them with the approval of the drug supervision and administration department of the State Council or the people's governments of provinces, autonomous regions and municipalities directly under the Central Government authorized by the State Council. Fifth, medical and health institutions develop medical device systems. It is stipulated that medical and health institutions can develop medical devices to deal with public health emergencies, and the management measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the health authorities of the State Council.
Seven, the "Regulations" on the improvement of legal responsibility.
In order to implement the "four strictest" requirements, increase illegal costs, protect people's health, and create a level playing field for law-abiding enterprises, the legal liability clauses of the original regulations have been revised mainly from three aspects: First, the scope of fines has been greatly increased. In particular, illegal acts involving quality and safety can be fined up to 30 times the value of the goods. The second is to increase the penalties for industry and market bans. In order to purify the market environment, those with serious circumstances will be expelled from the market, and the offenders will be punished according to the circumstances of violation, such as revoking their licenses, prohibiting them from engaging in related activities within a certain period of time, and not accepting relevant license applications. The third is to increase the "punishment to people" rule. For the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel of a serious illegal unit, the income obtained during the illegal act of the unit shall be confiscated, and a maximum fine of three times may be imposed, and it is forbidden to engage in related activities for five years until life. Legal basis: Regulations on the Supervision and Administration of Medical Devices
Article 6 The State implements classified management of medical devices according to the degree of risk.
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered.
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. To formulate and adjust the classification rules and classification catalogue, we should fully listen to the opinions of medical device registrants, filers, production and operation enterprises, users and industry organizations, and refer to international medical device classification practices. The classification rules and catalogue of medical devices shall be announced to the public.