The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective areas of responsibility. Article 4 The local people's government at or above the county level shall strengthen the leadership of the supervision and management of medical devices in the administrative area, organize and coordinate the supervision and management of medical devices and the response to emergencies in the administrative area, strengthen the supervision and management of medical devices and capacity-building, and provide protection 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 responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's government at or 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 to implement classification management.
The first category is a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices.
The second category is a moderate risk, need to strictly control the management to ensure its 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, use and other factors.
The drug supervision and management department of the state council is responsible for formulating the classification rules and classification directory of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the changes in the risk of medical devices, and adjust the classification rules and classification directory. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory shall be published to the public. Article VII medical device products should be in line with the mandatory national standards for medical devices; there is no mandatory national standards, should be in line with the mandatory industry standards for medical devices. Article 8 The state to develop medical device industry planning and policy, medical device innovation into the development priorities, innovative medical devices to be prioritized for review and approval, to support the clinical promotion and use of innovative medical devices, and to promote the high-quality development of the medical device industry. The drug supervision and management 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. Article 9 The state shall improve the medical device innovation system, support the basic and applied research of medical devices, promote the promotion and application of new technologies of medical devices, and support 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 universities, 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 capability of independent innovation of medical devices. Article 10 The state to strengthen the supervision and management of medical devices information construction, improve the level of online government services, to facilitate the administrative licensing of medical devices, filing. Article 11 The medical device industry organizations shall strengthen industry self-discipline, promote the construction of integrity system, supervise enterprises to carry out production and business activities in accordance with the law, and guide enterprises to be honest and trustworthy. Article XII of the research and innovation in medical devices to make outstanding contributions to the units and individuals, in accordance with relevant state regulations to give recognition and reward. Chapter II of the medical device product registration and filing Article XIII of the first class of medical devices to implement product record management, the second and third class of medical devices to implement product registration management.
Medical device registrants, the filing shall strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety, effectiveness and bear responsibility according to law. Article 14 The first class of medical device products for the record and apply for registration of the second and third class of medical device products, shall submit the following information:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection report;
(d) clinical evaluation information;
(e) product specifications as well as Labeling samples;
(F) and product development, production-related quality management system documents;
(G) to prove that the product is safe, effective and other information required.
The product inspection report shall meet the requirements of the State Council drug supervision and management department, can be the applicant for registration of medical devices, the filer of the self-inspection report, or commissioned by a qualified medical device inspection agency issued the inspection report.
Conforms to the provisions of Article 24 of the Regulations exempt from clinical evaluation of the situation, may be exempt from submitting clinical evaluation information.
Applicants for registration of medical devices, the filer shall ensure that the information submitted is legal, true, accurate, complete and traceable.