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.
- 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.
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, and design inputs; (2) Design Input—specify functional and performance requirements with traceability; (3) Design Output—document design specifications with verification against inputs; (4) Design Review—conduct formal reviews at key phases with documented evidence; (5) Design Verification—confirm design outputs meet design inputs through testing/analysis; (6) Design Validation—confirm final design meets user needs and intended use; (7) Design Changes—control and approve modifications with impact assessment. A complete Design History File (DHF) must be maintained and made available during regulatory inspections.