From China Food and Drug Administration informed: My will be implemented from March 1 this year "special approval process of innovative medical devices (Trial)", the program is listed in the product to ensure safe and effective premise for innovative medical devices set approval channels.
According to the procedural requirements, the food and drug administration departments at the same time meet the appropriate criteria for the medical device review and approval by the program implementation, such as the applicant shall have the core technology invention patent or patent application by the patent administration department under the State Council, open, product It should be at the international advanced level in technology, and has significant clinical value and so on. Domestic and overseas applicants may submit in accordance with the procedural requirements of the appropriate technical information and proof of filing the application for approval of innovative medical devices in particular; after review by the technical department of the organization considered to meet the relevant criteria, in accordance with the procedure described in the review and approval.