Analysis of the Common Problems of Combination Products Application.
10.3969/j.issn.1671-7104.2020.01.015
- Author:
Jiaxin TIAN
1
;
Yongqing WANG
2
;
Wei XU
2
;
Xiaobing FU
1
;
Yubo FAN
1
Author Information
1. School of Biological Science and Medical Engineering, BeiHang University, Beijing, 100083. ##Email#.
2. Center for Medical Device Evaluation, NMPA, Beijing, 100081. ##Email#.
- Publication Type:Journal Article
- Keywords:
combination product;
drug-medical device;
technical review
- MeSH:
Biomedical Technology
- From:
Chinese Journal of Medical Instrumentation
2020;44(1):68-70
- CountryChina
- Language:Chinese
-
Abstract:
The number of combination products is increasing, and the cutting-edge and innovative technologies are constantly being used. How to evaluate combination products become difficult points. This study team summarizes the supervision conditions of the combination products and analyzes the common problems of these products application from the perspective of technical review, in order to provide reference for Chinese manufacturers and investigators in these products registration.
