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China Continues To Enhance Post Market Surveillance On Medical Devices

2021-12-27

Since the implementation of Order 739 Regulations on Supervision and Administration of Medical Devices in June, 2021, China continues to enhance post-market surveillance on medical devices.

NMPA collected the public opinions on Measures For The Administration Of Medical Device Adverse Event Monitoring And Re-evaluation to enhance the adverse event and re-evaluation, timely and effectively control the post-market risk of medical devices, and ensure human health and life safety.

BradyKnows is legal agent for many overseas manufacturers. During the latest experiences for post-market surveillance on medical devices in China, Brady knows how to help your China business in compliance. To enhance post-market surveillance, the works should cover the below key aspects.

  • Review, evaluate the complaints is adverse event or not, and draft AE report
  • Draft recall files, fill the recall report and track
  • Draft adverse event self-inspection report
  • Review company SOP and evaluate gap when global SOP update, if need, BradyKnows helps update SOP
  • Improve the quality process
  • Prepare adverse event self-inspection report
  • Hold meeting for AE inspection, onsite training and audit for better passing the inspections from local authority
  • Draft periodic risk evaluate report for current products
  • Communicate with complaint handling department for adverse event
  • Understand the regulation update and inspection notice of NMPA
  • Handle custom issue of medical device in compliance
  • Chinese label and IFU update of medical device when registration certificate renewed
  • Chinese label and IFU of spare parts

In order to help overseas manufacturers understand more China quality requirements on medical device, BradyKnows will hold a workshop on Quality Assurance and Post-market Surveillance in Jan, 2022. Pls feel free to reach out to info@inspirativemed.com for any questions.