News
You are here：Home < News
From the State Food and Drug Administration informed: country will be implemented with effect from March 1 this year, "Innovative Medical equipment approval procedures (Trial)", the program is listed in the product to ensure safe, effective premise for innovative medical devices set approval channels.
According to the procedural requirements, food and drug supervision and management departments at the same time meet the corresponding conditions for medical device review and approval by the implementation of the program, for example, the applicant should have core technology patent or patent application for invention patent administration department under the State Council has been open, the product It should be at the international advanced level in technology, and has significant clinical value and so on. Domestic, foreign applicants may submit in accordance with the procedural requirements of the appropriate technical information and supporting documents, in particular for innovative medical device approval applications; After review by the technical sector organizations considered to meet the appropriate conditions, in accordance with the implementation of the program review and approval.
