After accepting the application, the administrative acceptance service center will send the application materials to the medical device technical review center for technical review, which includes product testing and expert review, and the longest technical review can not exceed 60 days. However, if the applicant puts forward rectification opinions after expert review, the applicant's rectification time shall not be included in the licensing time limit. Make a licensing decision within 90 days.
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software; Its effectiveness is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role; Its purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; Examination, substitution, adjustment or support of physiological structure or process; Support or sustain life; Pregnancy control; By examining human samples, information can be provided for medical or diagnostic purposes.