The State Administration of Food and Drug Administration has opened a review of innovative medical devices

Reporter December 20 from the State Food and Drug Administration was informed that in order to promote innovative medical device products to market as soon as possible, the General Administration of Food and Drug Administration in the review process dedicated green channel, the first 11 months of this year has completed 144 innovative medical devices special approval application review, agreed to 44 in accordance with the special approval procedures for approval.
, medical device science and technology are booming, and new technologies such as high-performance medical devices, tissue engineering products, medical 3D printing and mobile medical are developing rapidly.
how to promote innovative medical products in the premise of ensuring safety and effectiveness as soon as possible to market, for the common people to see a doctor to provide more convenience, become a major test of medical device review and approval capacity.
The relevant person in charge of the Equipment Registration Department of the General Administration of Food and Drug Administration introduced at a recent expert symposium on the reform of the medical device review and approval system that the General Administration of Food and Drug Administration issued the Special Approval Procedure for Innovative Medical Devices (Trial) in early 2014, giving priority to the approval of innovative medical devices on the premise that the standards are not lowered and the procedures are not reduced, in accordance with the principles of early intervention, special responsibility and scientific approval.
two years, as of the end of November this year, 88 innovative medical device products have entered the special approval channel, orthopaedic surgical navigation and positioning system, cold salt water radio frequency perfusion ablation catheter and other 20 innovative products have been approved for market.
, in order to further meet the clinical use needs of medical devices, the General Administration of Food and Drug Administration has formulated and issued the "Priority Approval Procedure for Medical Devices", which will be implemented from January 1, 2017.
The procedure will open up a green channel for the diagnosis or treatment of rare diseases, malignant tumors, diseases specific to the elderly, specific to children, clinical needs, and medical devices included in major national science and technology projects or key research and development programs.
recent years, the total market for medical devices has grown from more than 120 billion yuan in 2010 to more than 420 billion yuan in 2015, with a compound annual growth rate of more than 25%, according to the China Pharmaceutical Industry Information Center.
, Director General of the General Administration of Food and Drug Administration, said at the symposium that the reform is to further enhance the ability of medical devices to review and approve, to ensure the safety and effectiveness of public firearms, and to promote the healthy development of the medical device industry. It is necessary to establish a technical support system with review as the core, optimize the review and approval procedures, and continuously improve the quality and efficiency of review and approval. Xinhua News Agency