[Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices].

Abstract

The structural characteristics and clinical application of embolic microspheres were summarized in this paper. According to evaluation experience and current regulatory registration evaluation requirements, registration evaluation concerns on embolic microsphere as medical device were analyzed from four aspects: administration attributes, product description, non-clinical studies and clinical evaluation, in order to provide references for the development and registration application of such products and improve the efficiency of registration application.