YY/T 1998-2026 Pending Industry standards-Medicine

YY/T 1998-2026 General requirements for clinical investigation of in vitro diagnostic reagents

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 1998-2026

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: 24 pages

Scope

This document specifies the general quality requirements for the entire process of clinical trials conducted to evaluate the clinical performance and safety of in vitro diagnostic (IVD) reagents, including clinical trial planning, protocol design, implementation, monitoring, inspection, data collection, recording, storage, analysis, summary, and reporting.
This document applies to clinical trials of in vitro diagnostic reagents conducted for registration purposes.