The State Food and Drug Administration announced the priority approval process for medical devices

In order to further implement the State Council's opinion on reforming the drug and medical device review and approval system and guarantee the clinical use of medical devices, the State Food and Drug Administration has conducted in-depth research and extensive consultation, and recently issued the “Medical Device Priority Approval Procedure”, since 2017. It will take effect on January 1 of the year.

According to the procedure, the Food and Drug Administration has implemented priority approval for the following medical devices: First, medical devices that diagnose or treat rare diseases, malignant tumors and have obvious clinical advantages, diagnose or treat elderly-specific and multiple diseases, and there is no effective diagnosis yet. Medical devices with therapeutic means, medical devices that are dedicated to children and have obvious clinical advantages, medical devices that are urgently needed in clinical practice and are not approved for registration in China; second, medical products listed in the national science and technology major projects or national key research and development programs instrument. In addition, the General Administration of Food and Drug Administration will, based on various aspects and opinions, organize an expert review to determine the priority approval for “other medical devices that should be approved in priority”.

For the projects that are given priority for approval, the State Food and Drug Administration will speed up the review and approval of the whole process, prioritize technical review, prioritize the verification of medical device registration quality management system, prioritize administrative approval, shorten product time-to-market, and ensure The corresponding results and products can be applied to clinical use as soon as possible.

The issuance of this procedure is a concrete manifestation of the implementation of the State Council's requirements for transforming government functions and promoting the work of “distributing services”. It will further promote the development of China's medical device industry, promote the urgent need for clinical products and other products to enter the market as soon as possible, and improve the people's health. Health level.

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