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 Regulations clearly states that the state formulates plans and policies for the medical device industry, brings the innovation of medical devices 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.
At the same time, the state improves the medical device innovation system, supports basic research and applied research of medical devices, promotes the popularization and application of new technologies of medical devices, and supports scientific and technological project approval, financing, credit, bidding and procurement, medical insurance and other aspects.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 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 state regulations.
Compared with the previous Regulation, the new Regulation points out that medical device registrants and record holders should strengthen the quality management of the whole life cycle of medical devices, and assume legal responsibilities for the safety and effectiveness of medical devices in the whole process of research, production, operation and use.The Regulations on the Administration of Medical Devices mentioned that registrants and recorders should fulfill the following obligations: to establish a quality management system suitable for the product and to maintain effective operation;Develop post-listing research and risk control plans and ensure their effective implementation;Adverse event monitoring and reevaluation shall be carried out according to law;Establish and implement product traceability and recall system;Other obligations stipulated by the pharmaceutical supervisory and administrative department under the State Council.
The medical device registration applicant and the record holder shall ensure that the materials submitted are legal, true, accurate, complete and traceable.In carrying out clinical trials, the state supports medical institutions in carrying out clinical trials, includes evaluation of clinical trial conditions and capabilities in the hierarchical evaluation of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.
With regard to the production of medical devices, the registrant and the record holder of medical devices may produce medical devices by themselves, or may entrust an enterprise that meets the provisions of these Regulations and meets corresponding conditions to produce medical devices.However, the production of implanted medical devices with high risks shall not be commissioned. The specific catalogue shall be formulated, adjusted and promulgated by the drug regulatory department under the State Council.
According to the regulation, the state will implement a unique identification system for medical devices step by step according to the category of medical devices, so that the medical devices can be traced back. The specific measures will be formulated by the drug regulatory department under the State Council in conjunction with the relevant departments of the State Council.In addition, the medical device users shall properly keep the original data of the third category of medical devices purchased, and ensure the traceability of the information.Where large medical devices and implanted and interventional medical devices are used, the name, key technical parameters and other information of the medical devices as well as the necessary information closely related to the quality and safety of use shall be recorded in the medical records and other relevant records.
