GMP and Quality System Guidance
This page indexes GMP and quality system guidance documents published by NMPA and CMDE. Content is being expanded. Below are direct links to official sources.
Finding official guidance
NMPA technical guidance documents are published on:
- CMDE website: www.cmde.org.cn → 指导原则 (Technical Review Guidelines)
- NMPA website: www.nmpa.gov.cn → 医疗器械 → 法规文件
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.
China's GMP (Good Manufacturing Practice) requirements for medical devices are outlined in the Regulations for the Supervision and Administration of Medical Device Production Quality Management (医疗器械生产质量管理规范), which establishes requirements aligned with ISO 13485 QMS principles. Key areas include: facility design and maintenance, personnel qualifications, equipment validation, production controls, quality assurance, complaint handling, and documentation. Manufacturers must comply with QMS principles aligned with ISO 13485. NMPA conducts routine GMP inspections as part of pre-approval site audits and ongoing post-market surveillance, with compliance mandatory for initial market authorization and continued market access.