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Standards — YY/T and GB National Standards

This page provides a plain English reference for standards — yy/t and gb national standards in China's medical device regulatory framework. Full content to be completed during editorial review.

Overview​

See MDSAR 2021 for the primary regulation. This page covers the implementing measure or standard listed above, explaining its scope, key requirements, and relationship to MDSAR 2021.

Official source​

Official texts are published on www.nmpa.gov.cn and the State Council website at www.gov.cn.

Disclaimer

Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.

Scope​

YY/T and GB standards establish technical and quality requirements for medical device categories. These are referenced in MDSAR 2021 and are integral to device registration, manufacturing, and post-market compliance.

Key Standards Categories​

  • YY/T standards: Industry standards specific to medical device types (e.g., YY/T 0287 for IVD general requirements)
  • GB standards: National standards with cross-sector application (e.g., GB 18030 for software character coding)
  • Referenced standards: Device technical dossiers must demonstrate compliance with applicable YY/T or GB standards
  • Standard updates: Manufacturers must monitor standard updates and update device specifications accordingly

Standards in Registration​

  • Dossier must cite applicable standards and document compliance
  • NMPA review includes assessment of standard compliance
  • Post-market changes affecting standard compliance require notification to NMPA

Where to Find Standards​

  • YY/T standards searchable on www.nmpa.gov.cn
  • GB standards available via China Standards Information Network (www.std.gov.cn)
  • Manufacturers typically purchase standards directly from standards bodies