YY/T 0297-2026 English, YY/T 0297-2026 General requirements for clinical investigation of medical devices (English)

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YY/T 0297-2026 General requirements for clinical investigation of medical devices (English)
Standard No.:	YY/T 0297-2026	Status:	to be valid remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	16000 words	Translation Price(USD):	480.0 remind me the price change Email:
Implemented on:	2027-3-1	Delivery:	via email in 1~5 business day

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Standard No.:	YY/T 0297-2026
English Name:	General requirements for clinical investigation of medical devices
Chinese Name:	医疗器械临床试验质量通用要求
Professional Classification:	YY Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Administration
Issued on:	2026-03-09
Implemented on:	2027-3-1
Status:	to be valid
Superseding:	YY/T 0297-1997 Clinical investigation of medical devices
Target Language:	English
File Format:	PDF
Word Count:	16000 words
Translation Price(USD):	480.0
Delivery:	via email in 1~5 business day

Standard

YY/T 0297-2026 General requirements for clinical investigation of medical devices (English Version)
Standard No.	YY/T 0297-2026
Status	to be valid
Language	English
File Format	PDF
Word Count	16000 words
Price(USD)	480.0
Implemented on	2027-3-1
Delivery	via email in 1~5 business day

Detail of YY/T 0297-2026

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Introduction of YY/T 0297-2026

本文件规定了医疗器械上市前临床试验全过程的质量通用要求，包括医疗器械临床试验的方案设计、实施、监查、稽查、检查以及数据的采集、记录、保存、分析、总结和报告等。
本文件适用于以注册为目的的医疗器械临床试验。
本文件不适用于体外诊断试剂。

Contents of YY/T 0297-2026


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Keywords:
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