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.
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 calendar days for Class II, 60 calendar days for Class III. Timeline pauses (clock-stop) when NMPA issues information requests; clock resumes upon applicant response.
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.