National Food and Drug Administration Releases Priority Approval Process for Medical Devices

According to this procedure, the General Food and Drug Administration will give priority approval to the following medical devices: First, diagnosis and treatment of rare diseases, malignant tumors, medical devices with obvious clinical advantages, diagnosis or treatment of specific and multiple diseases in the elderly, and no effective diagnosis Medical devices for treatment or treatment, medical devices with special clinical features for children, clinically urgently needed medical devices without approval for registration of the same type of products in China, and second, medical devices listed in major national science and technology projects or national key R&D programs. instrument. In addition, the General Administration of Food and Drug Supervision will, after reviewing all aspects and opinions, organize experts to review and determine to give priority approval to “other medical devices that should be given priority for approval”.

For projects that have been identified as prioritized for approval, the State Food and Drug Administration will expedite the review and evaluation of batches in all aspects, prioritize technical review, prioritize inspections of medical device registration quality management systems, give priority to administrative approval, shorten product launch times, and ensure The corresponding results and products can be applied clinically as soon as possible.

The issuance of this procedure is a concrete embodiment of implementing the State Council's requirements for transforming government functions and promoting the work of “distribution of the service”. It will further promote the development of China's medical device industry, promote the clinical urgent needs and other products to enter the market as soon as possible, and enhance the people's masses to achieve better health. Health level.