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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 and YY/T 0287-2017 scope, including documented evidence of CAPA investigation, effectiveness verification, and trending analysis.

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.

CAPA Requirements: Manufacturers must establish documented procedures for identifying, investigating, and correcting non-conformances and complaints. CAPAs must include root cause analysis, corrective action definition with timelines, preventive measures to avoid recurrence, and verification of effectiveness. For post-market issues, CAPA reports must be submitted to NMPA if they affect device safety or effectiveness. YY/T 0287-2017 requires documented evidence of CAPA closure and trending analysis of recurrent issues. NMPA GMP inspections routinely assess CAPA system adequacy and timeliness of implementation.