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CAPA

This page provides a plain English reference for capa 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.