Standard No.:	T/CGCPU 030-2024
English Name:	Specification for the design of clinical trial protocols for radiofrequency skin treatment medical devices
Chinese Name:	射频皮肤治疗仪临床试验方案设计规范
Chinese Classification:	C41    Medical ultrasound, laser, high-frequency instrument and equipment
Professional Classification:	T/    Social Organization Standard
ICS Classification:	11.040.60 11.040.60    Therapy equipment 11.040.60
Source Content Issued by:	GCP Union
Issued on:	2024-11-28
Implemented on:	2024-11-28
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了射频皮肤治疗仪用于减轻皮肤皱纹的临床试验方案设计规范，包含设计依据、设计原则、设计内容和设计验证。
本文件适用于研制企业开展以注册为目的的临床试验方案设计。