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China Agent Obligations

The China Agent's obligations span the full regulatory lifecycle — from pre-market registration through to ongoing post-market compliance.

Pre-market obligations​

  • Submit registration or filing application on behalf of the overseas manufacturer
  • Maintain the registration dossier including product technical requirements, clinical evaluation, and quality system documentation
  • Ensure Chinese labelling meets NMPA mandatory requirements before market entry
  • Manage registration changes — submit change supplements when the device, manufacturer, or Agent details change

Post-market obligations​

Adverse event reporting​ The China Agent must: Establish and maintain an adverse event monitoring system with documented procedures for identifying, investigating, and reporting events Report serious adverse events (causing hospitalization, disability, or other serious health consequences) to NMPA within 30 days of becoming aware Report events causing death or serious injury immediately and no later than 15 days; deaths must be reported as soon as possible Report events resulting in product recalls or FSCAs to NMPA within required timeframes Submit periodic adverse event trend reports (typically semi-annual) as required by NMPA

Recalls and FSCAs​

  • Co-ordinate and execute recalls of defective devices within China
  • Submit recall plans to NMPA within specified timeframes
  • Publish Field Safety Notices (FSN — 安全警示) as required

Annual report​

Submit an annual self-assessment report to NMPA on behalf of the overseas manufacturer.

GMP co-operation​

  • Facilitate NMPA overseas inspection of the manufacturer's facilities
  • Provide translations and logistical support as required

Consequences of Agent failure​

NMPA may take enforcement action against the China Agent for failures in its obligations, including:

  • Warning letters
  • Suspension of the Agent's ability to act for additional overseas manufacturers
  • Fines

Joint liability for product quality means the Agent may also face liability in civil claims arising from device defects.

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.