首页|基于技术审评的单孔多通道腹腔镜穿刺器产品的思考

基于技术审评的单孔多通道腹腔镜穿刺器产品的思考

Reflections on Single-Hole Multi-Channel Laparoscopic Puncture Device Based on Technical Review

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随着微创外科技术的不断发展,单孔多通道腹腔镜穿刺器在腹腔镜手术中的应用越来越广泛.文章从技术审评角度对单孔多通道腹腔镜穿刺器进行分析,详述单孔多通道腹腔镜穿刺器审评重点和难点,为单孔多通道腹腔镜穿刺器产品的科学监管提供参考.
With the progress of minimally invasive surgery,the application of single-hole multi-channel laparoscopic puncture device in the laparoscopic surgery is becoming increasingly widespread.This paper analyzes single-hole multi-channel laparoscopic puncture device from the perspective of technical review,elaborates on the key points and challenges in the evaluation,and provides reference for the scientific supervision of single-hole multi-channel laparoscopic puncture device.

single-holelaparoscopicpuncture devicescientific supervision

夏庭庭、戴清、张道君

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江苏省药品监督管理局审评中心 (江苏 南京 210000)

单孔 腹腔镜 穿刺器 科学监管

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(19)