The current registered copper bearing intrauterine devices in China and their performance
10.3760/cma.j.cn101441-20210222-00079
- VernacularTitle:中国现行注册的含铜宫内节育器及其性能评价项目
- Author:
Wenbo LIU
1
;
Yan ZHAO
;
Xinli SHI
;
Peng ZHAO
;
Lina XING
;
Changjin HUANG
;
Yifei ZHAO
Author Information
1. 国家药品监督管理局医疗器械技术审评中心，北京 100081
- Publication Type:Journal Article
- Keywords:
Copper bearing intrauterine device;
Structure and composition;
Performance evaluation;
Biocompatibility
- From:
Chinese Journal of Reproduction and Contraception
2021;41(8):694-701
- CountryChina
- Language:Chinese
-
Abstract:
Copper bearing intrauterine device (Cu-IUD) is a widely used contraceptive method for women of childbearing age in China. It plays an important role in family planning and population control in China. In recent years, Cu-IUD is still used by hundreds of millions of women in China, and such devices still attract more attention in the field of women's health. This paper collects the information of all the 31 Cu-IUD products with valid registration certificate in China, including product name, manufacturer name, IUD structure and composition, schematic diagram, etc. From the perspective of safety and effectiveness evaluation of IUD, this paper reviewed and evaluated the relevant properties of Cu-IUD implanted in uterine cavity, including physical properties, chemical properties, biocompatibility evaluation, and clinical application related performance studies.
