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Supplier Management

This page provides a plain English reference for supplier management 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.

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.

Supplier Management Requirements: Manufacturers must establish documented procedures to evaluate and approve all suppliers of materials, components, and services critical to device quality and safety. YY/T 0287-2017 requires: (1) Supplier Evaluation—assess supplier capability, quality systems, and compliance history before approval; (2) Purchasing Data—clearly specify purchased product requirements including drawings, specifications, process requirements, and quality standards; (3) Supplier Monitoring—conduct periodic audits (on-site or documentation review) to verify continued compliance; (4) Incoming Acceptance—establish acceptance criteria and inspection procedures for purchased products; (5) Supplier Records—maintain records of evaluations, approvals, audits, and corrective actions. NMPA expects evidence of supplier audits, certificates of analysis, supplier quality agreements, and documented responses to non-conformances. Suppliers must comply with applicable regulations in their jurisdiction and provide documentation supporting device traceability and batch control.