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Design Controls

This page provides a plain English reference for design controls 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.

Design Control Requirements: NMPA expects documented design control processes aligned with YY/T 0287-2017 (equivalent to ISO 13485:2016). Key elements include: (1) Design Planning—define intended use, user needs, design and development strategy, and design inputs with stakeholder input; (2) Design Input—specify functional and performance requirements with traceability matrices; (3) Design Output—document design specifications and drawings with verification against design inputs; (4) Design Review—conduct formal multidisciplinary reviews at critical phases (concept, design, pre-production) with documented meeting minutes and evidence of resolution of issues; (5) Design Verification—confirm design outputs meet design inputs through objective testing, analysis, or demonstration; (6) Design Validation—confirm final design meets user needs and intended use in simulated or actual use conditions; (7) Design Changes—control and approve all modifications with documented impact assessment and re-verification/re-validation as needed. A complete Design History File (DHF) documenting all phases must be maintained in Chinese or English and made available during regulatory inspections.