Production Supervision & Administration Measures
This page provides a plain English reference for production supervision & 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 III (Articles 44-57), establishing requirements for medical device manufacturing, including production licensing, GMP compliance, quality management systems, and regulatory oversight.
Key Requirements
- Production licence required for Class II and III device manufacturers; Class I device manufacturers are exempt from licensing but must maintain quality systems
- GMP (Good Manufacturing Practice) compliance mandatory; QMS documentation required
- Quality personnel: at least one qualified person responsible for quality
- Batch record retention: minimum 5 years after device shelf life expiration
- Change control procedures for manufacturing processes and facility modifications
- Regular internal audits and management review of QMS
- NMPA inspection authority: unannounced facility inspections permitted
Relationship to MDSAR 2021
This measure operationalizes Article 44 (production licence) and Articles 47-49 (GMP and quality system) of MDSAR 2021 Chapter III with detailed procedural and technical requirements.