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• Create Date August 25, 2022
• Last Updated October 18, 2022

Part 1 - Overview PMS Key Updates - Enhanced Requirements of Post Market Surveillance Per Order 739

More and more overseas manufacturers are having their products made in China to compete more favorably. Whether the devices sold in China are from overseas imports or domestically made, they must be in compliance with China GMP. After the implementation of the Order 739: Regulations on Supervision and Administration of Medical Devices in June 2021, China has been increasing its surveillance on post market monitoring with more follow-on guidelines and random inspections both inside China and outside of China. Knowing more about the newly published guidelines, and learning from the previous cases, get more insights to comply with China PMS/GMP Regulations!

This session will address the key topics of:

• More rigorous PMS/GMP requirements per Order 739
• Newly updated PMS/GMP Guidelines
• Typical Observations in Post Market Overseas Inspections
• Best Practices for Post Market QMS compliance and remediation – Product Verification with China PTR

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