YY/T 0297-2026 Pending Industry standards-Medicine

YY/T 0297-2026 General requirements for clinical investigation of medical devices

Publish Date: 2026-03-09 Implement Date: 2027-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0297-2026

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2026-03-09

Implement Date: 2027-03-01

Pages: 36 pages

Scope

This document specifies the general quality requirements for the entire process of pre-market clinical trials of medical devices, including the design, implementation, monitoring, inspection, and data collection, recording, storage, analysis, summary, and reporting of medical device clinical trials.
This document applies to clinical trials of medical devices for registration purposes.
This document does not apply to in vitro diagnostic reagents.