China Continues To Enhance Post Market Surveillance On Medical Devices

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.