NMPA GMP Inspections
This page provides a plain English reference for nmpa gmp inspections under China's NMPA regulatory framework. Full content to be completed during editorial review.
Regulatory basis
- MDSAR 2021 (State Council Order No. 739)
- Medical Device Production Supervision and Administration Measures (NMPA Order No. 53)
- YY/T 0287-2017 (equivalent to ISO 13485:2016)
Key requirements
See NMPA GMP guidance for the latest inspection requirements and GMP standards applicable to your device class and manufacturing scope.
- NMPA — www.nmpa.gov.cn
- CMDE — www.cmde.org.cn
- NMPA Medical Device Registration Query — datasearch.nmpa.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.
NMPA GMP Inspection Process: NMPA conducts routine, scheduled GMP inspections and unannounced compliance inspections. Inspection frequency depends on device class and prior compliance history—typically Class III devices face more frequent inspections. Inspectors assess compliance with YY/T 0287-2017 across all QMS elements including management responsibility, design controls, document control, production control, supplier management, and post-market surveillance. Common non-compliance findings include inadequate design validation, insufficient traceability systems, poor CAPA documentation, inadequate training records, and inadequate complaint handling. Manufacturers should prepare evidence of compliance including design history files, batch records, supplier evaluations, inspection/testing records, and post-market surveillance documentation. Non-compliance findings must be addressed with documented corrective actions submitted within specified timeframes.