Analysis of adverse reactions of clinical application of facial injection filler materials and pre-market adverse reaction evaluation requirements
10.3969/j.issn.1672-8270.2024.07.030
- VernacularTitle:面部注射填充材料临床应用不良反应及上市前不良反应评价要求分析
- Author:
Weilu CHENG
1
;
Lingdan XU
;
Hong QIU
;
Yinghui LIU
;
Lu LIU
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
- Keywords:
Facial injection;
Filler material;
Research progress;
Adverse reaction
- From:
China Medical Equipment
2024;21(7):165-171
- CountryChina
- Language:Chinese
-
Abstract:
A variety of facial injection filler materials have been approved for market at home and abroad.The marketing approvals,clinical application literature,expert consensus or clinical application guidelines of facial injection filler products at home and abroad were collected and it was found that facial injection filler materials may cause a number of adverse reactions.The clinical application and adverse reactions of facial injection filler materials were summarized,the pre-market adverse reaction evaluation requirements of such products in the United States and China were analyzed and summarized,aiming to provide reference for relevant product developers and clinical researchers to evaluate the pre-market adverse reactions of facial injection filler materials.
