It was learned from the State Food and Drug Administration that China will implement the “Special Approval Procedures for Innovative Medical Devices (Trial)” from March 1 this year, which is an approval channel set up for innovative medical devices on the premise of ensuring the safety and effectiveness of listed products.
According to the procedure, the food and drug supervision and administration department shall review and approve the medical devices that meet the corresponding conditions according to the procedure, for example, the applicant shall have the invention patent right of the core technology of the product or the invention patent application has been disclosed by the patent administration department of the State Council, and the product shall be at the international leading level in technology and have significant clinical application value. Domestic and overseas applicants can submit corresponding technical information and supporting documents in accordance with the procedural requirements to apply for special approval of innovative medical devices; If it is deemed that the corresponding conditions are met after the review organized by the technical department, the review and approval may be carried out in accordance with the procedures.