Deputy Director Lu pointed out that 2017 witnessed the in-depth development of the reform of the medical device review system. The center earnestly implemented various tasks, strengthened system planning, paid close attention to implementation, deepened the reform of the review mechanism, encouraged innovation, optimized the review and approval process, standardized review management, advanced personnel system reform, strengthened informatization support and improved review quality and efficiency. Therefore, the reform progresses in a steady pace.
As regards issues of concern to enterprises, Deputy Director Lu pointed out that in 2018, the center will further encourage the research and development of medical devices, focusing on strengthening the work in the following areas.
The center will continue to strengthen the review of innovation and priority applications, revise and perfect the Standard Review Procedures for Innovation Application and Standard Procedures for Prior Review. The center will establish special channels to conduct prioritized review on innovative medical devices and products supported by major national science and technology projects, national key R&D program and approved by the central management department after passing through clinical trials conducted by the national center for clinical medicine research.
The center will strive to perfect relevant review requirements for the clinical evaluation. The center will revise the Guiding Principles for Clinical Evaluation of Medical Devices to clarify the basic principles for clinical trials of the third category medical devices, perfect and pass the requirements for clinical evaluation of clinical data of similar products. The center will draft the Administrative Measures for the Development of Medical Device Expansive Clinical Trials to clarify the requirements for the development of expansive clinical trials, data acceptance requirements and evaluation principles, and standardize the scientificness, rationality, enforceability, and predictability of clinical evaluations. Data from overseas clinical trials can be used to apply for registration in China if it meets the relevant requirements for medical device registration in China.
The center will improve the review system of special medical devices urgently needed for clinical treatment. The center will study and formulate standard review procedures and registered technology review guidelines for medical devices for the treatment of severely life-threatening diseases, of clinical significance, and in urgent clinical need for the treatment of rare diseases. The center will refine and perfect the requirements for declaration materials, set up priority channels for review, and accelerate the conditional approval for the commercialization of clinically urgently needed medical devices.
In his conclusion, Deputy Director Lu pointed out that various measures for the review, examination and approval of medical devices will be finalized in 2018. The center will continue to thoroughly implement the Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices, deepen the reform of the review system, encourage product R&D and innovation, pay close attention to internal management, strive to improve the capabilities of reviewers, lift the work to a new level and make due contributions to the supervision of medical devices and the healthy development of industries and the safety of public machinery.