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Application for Innovative Medical Device (Imported)

The Medical Products Administration authority will give priority to the technical review and administrative approval of medical devices that meet all the following conditions:


(1) The applicant, through its technological innovation activities, has the patent right of the core technology invention in China according to law, or obtains the invention patent right or the right of use of the invention through the transferee in China or the patent application of the core technology has been made public by the Patent Administration Department Under the State Council.


(2) The main working principle / mechanism of the medical device is a national initiative. The product performance or safety has a fundamental improvement compared with its similar device(s), with technically a leading international level. The device has significant value in clinical application.


(3) The applicant has completed the preliminary study of the product and finalized the designed product, the study process is real and controlled, and the study data is complete and traceable.

SERVICES & SOLUTIONS
Service process Official Dees Time Distribution Related Services

Official Administrative Charges:


NMPA does not charge for innovative medical device application. Whether the application for innovative medical devices is approved or not, the official administrative charges for the initial registration of the medical device (Class II/III) will not be affected. The fees payable can be reduced or exempted in the case of the initial registration of innovative medical device involving a manufacturer who is a micro- or small-sized enterprise.


Time Distribution


60 working days in theory


Initial Registration of Imported Class III MD

Registration Renewal of Imported Class III MD

Initial Registration of Imported Class II MD

Registration Renewal of Imported Class II MD

Application for Innovative Medical Device (Imported)


Initial Registration of Imported Class III IVD

Registration Renewal of Imported Class III IVD

Initial Registration of Imported Class II IVD

Registration Renewal of Imported Class II IVD

Application for Innovative Medical Device (Imported)


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