What is an innovative medical device

(a) The applicant, after its technological innovation activities, in China, according to law, has the product core technology invention patent rights, or according to law, through the transfer of the invention patent rights in China or its right to use; or core technology invention patent application has been made public by the State Council's administrative department of patent.

(ii) The main working principle/mechanism of the product is the first of its kind in China, the performance or safety of the product has been fundamentally improved in comparison with similar products, and the technology is at the international leading level, and it has significant clinical application value.

(c) The applicant has completed the preliminary study of the product and has the basic stereotypes of the product, the research process is real and controlled, the research data is complete and traceable.