摘要
该研究通过统计2020年4月至2023年4月上海市第二类创新医疗器械特别审查申请情况,汇总分析了创新审查申请阶段的常见问题,并给出改进建议,供申请人和审查人员参考,以期进一步提高创新申请资料质量,提高创新申请的通过率。
This study conducted statistics on the special review applications for ClassⅡinnovative medical devices in Shanghai from April 2020 to April 2023.It summarized and analyzed common problems in the innovation review application stage,and gave suggestions for applicants and reviewers in order to further improve the quality of innovation application and improve the pass rate of innovation applications.
作者
谢琼
XIE Qiong(Shanghai Medical Device and Cosmetics Evaluation and Verification Center,Shanghai,200020)
出处
《中国医疗器械杂志》
2024年第1期85-87,共3页
Chinese Journal of Medical Instrumentation
关键词
第二类创新医疗器械
审查
常见问题
Class II innovative medical device
review
common problems
