China opens a green channel for the approval of innovative medical devices

The reporter learned from the State Food and Drug Administration that in order to promote innovative medical device products in the morning, the Food and Drug Administration has set up a green channel in the review process. In the first 11 months of this year, 144 innovative medical device special approval applications have been reviewed and approved. 44 were approved in accordance with the special approval procedures.

At present, medical device science and technology are booming, and new technologies such as high-performance medical equipment, tissue engineering products, medical 3D printing, and mobile medical care are developing with each passing day. How to promote innovative medical equipment products in the morning to ensure safety and effectiveness, to provide more convenience for the people to see a doctor, to become a major test of the ability of medical equipment review and approval.

The relevant person in charge of the Equipment Registration Department of the Food and Drug Administration introduced at the symposium on the reform of the medical device review and approval system held recently. The Food and Drug Administration issued the "Special Approval Process for Innovative Medical Devices (Trial)" in early 2014, in accordance with early intervention. The principle of special person responsible for scientific examination and approval shall give priority to the examination and approval of innovative medical devices under the premise that the standards are not reduced and the procedures are not reduced. In the past two years, as of the end of November this year, 88 innovative medical device products have entered the special approval channel, and 20 innovative products such as orthopedic surgery navigation and positioning system and cold saline RF perfusion ablation catheter have been approved.

According to the introduction, in order to further meet the clinical use requirements of medical devices, the Food and Drug Administration has issued the “Approval Approval Procedure for Medical Devices”, which will be implemented on January 1, 2017. The procedure will open up a green channel for the diagnosis or treatment of rare diseases, malignant tumors, peculiar and multiple diseases of the elderly, children dedicated to the clinic, urgent clinical needs, and medical devices listed in the National Science and Technology Major Special Project or key research and development programs.

According to the statistics of China National Pharmaceutical Industry Information Center, in recent years, the total medical device market has grown from more than 120 billion yuan in 2010 to more than 420 billion yuan in 2015, with an average compound annual growth rate of over 25%.

Bi Jingquan, director of the Food and Drug Administration, said at the symposium that reform is to further improve the ability of medical device review and approval, to ensure the safety and effectiveness of public health, and to promote the healthy development of the medical device industry. It is necessary to establish a technical support system that is rated as the core, optimize the review and approval procedures, and continuously improve the quality and efficiency of the review and approval.

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