Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices.
10.12455/j.issn.1671-7104.240422
- Author:
Xiangmei ZHANG
1
;
Yidan ZHANG
1
;
Xiaoqi LIAN
1
Author Information
1. Greater Bay Area Center for Medical Device Evaluation and Inspection, NMPA, Shenzhen,
- Publication Type:Journal Article
- Keywords:
animal study;
clinical evaluation;
embolic microsphere devices;
performance research
- MeSH:
Microspheres;
Device Approval;
Embolization, Therapeutic/instrumentation*
- From:
Chinese Journal of Medical Instrumentation
2025;49(2):224-229
- CountryChina
- Language:Chinese
-
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.
