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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 system certifications (e.g., ISO 13485, ISO 9001), regulatory compliance history, and technical competence before initial approval; (2) Purchasing Data—clearly specify purchased product requirements including technical specifications, drawings, acceptance criteria, process requirements, and applicable quality/regulatory standards; (3) Supplier Monitoring—conduct periodic audits (on-site audits recommended at least once per contract period for critical suppliers, or documented review of quality metrics) to verify continued compliance; (4) Incoming Acceptance—establish acceptance criteria and inspection/testing procedures for all critical purchased materials and components; (5) Supplier Records—maintain comprehensive records of evaluations, approvals, audit reports, certificates of analysis, and documented corrective actions. NMPA expects evidence of supplier audits, quality agreements defining responsibilities, certificates of analysis or compliance documentation, and prompt resolution of supplier non-conformances. Suppliers must comply with applicable regulations in their jurisdiction and provide documentation supporting full device traceability and batch/lot control.