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 basisβ
- 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 requirementsβ
See NMPA GMP guidance for the latest inspection requirements and GMP standards applicable to your device class and manufacturing scope.
Official Sources
- NMPA β www.nmpa.gov.cn
- CMDE β www.cmde.org.cn
- NMPA Medical Device Registration Query β datasearch.nmpa.gov.cn
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.