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IVD Registration & Filing Administration Measures

This page provides a plain English reference for ivd registration & filing administration measures 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​

This measure establishes separate registration and filing procedures for in vitro diagnostic devices (IVDs), recognizing their distinct risk profile and technical requirements compared to general medical devices.

Key Requirements​

  • IVDs on NMPA's List A may be filed (not registered) with simplified documentation
  • Other IVDs follow standard Class II registration or Class III registration pathways
  • Analytical and clinical performance validation required based on IVD classification
  • Quality standards must reference applicable YY/T industry standards for the specific IVD category (e.g., YY/T 0287 for general IVD requirements, or category-specific standards) or GB national standards, with documented compliance demonstrated in the technical dossier
  • China Agent mandatory for imported IVDs
  • Post-market surveillance and adverse event reporting obligations

Relationship to MDSAR 2021​

This measure implements Articles 10-43 of MDSAR 2021 (Chapter II), providing IVD-specific guidance on registration and filing with tailored requirements reflecting IVD regulatory classification.