Skip to main content

Registration & Filing Administration Measures

This page provides a plain English reference for 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 implements MDSAR 2021 Chapter II (Articles 10-43), establishing detailed procedures for device registration and filing, including dossier requirements, review timelines, and certificate issuance.

Key Requirements​

  • Class I filing: Simplified process; general description, standards compliance, and statement of responsibility
  • Class II registration: Dossier includes technical documentation, quality system summary, and clinical data (if required)
  • Class III registration: Full dossier with comprehensive clinical data, clinical trials, or equivalence justification
  • China Agent mandatory for all imported devices (Article 39); joint liability with foreign manufacturer
  • Dossier language: Chinese required; English originals may be submitted with certified translation
  • Review timeline: 30 days for Class II, 60 days for Class III (may extend with additional information request)

Relationship to MDSAR 2021​

This measure operationalizes Articles 13-16 (classification and registration requirements) and Articles 20-39 (dossier content and certificate issuance) of MDSAR 2021 Chapter II.