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GMP Requirements

This page provides a plain English reference for gmp requirements 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 published on www.nmpa.gov.cn and YY/T 0287-2017 detailed GMP compliance is verified through both scheduled routine inspections and unannounced compliance inspections. inspection requirements and GMP standards applicable to your device class and manufacturing scope.

Official Sources
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.

NMPA GMP Framework: NMPA GMP requirements are mandated by MDSAR 2021 and detailed in the Medical Device Production Supervision and Administration Measures (NMPA Order No. 53). YY/T 0287-2017 serves as the quality management system standard. Key GMP requirements include: (1) Management Responsibility—defined quality policy, organizational structure, and management review; (2) Design and Development—controlled design processes with validation; (3) Document Control—procedures for creation, review, approval, and change management; (4) Production and Service Control—controlled manufacturing with defined work instructions and in-process controls; (5) Purchasing Control—supplier evaluation and material acceptance; (6) Identification and Traceability—batch tracking and recall capability; (7) Production and Service Provision—cleanliness, contamination prevention, and process controls; (8) Inspection, Measurement, Analysis and Improvement—testing protocols, statistical analysis, and CAPA; (9) Post-Market Surveillance—adverse event monitoring and complaint handling. Compliance is verified through scheduled and unannounced GMP inspections.