In our previous Part I webinar, we gave the big picture of China PMS/GMP requirements and talked about the major updates per Order 739. Our Part II webinar will focus on Labeling and IFU, the two critical documents that must be consistent with NMPA approved certificates to comply with China post market requirements. Violations could result in recall or products being held up at customs. 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 meet China GMP and post market requirements. 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 unannounced inspections both inside and outside China. Knowing more about the newly published guidelines, and learning from the previous cases, get more insights to comply with China PMS/GMP Regulations!

Our Part II session will address the topics of:

• China NMPA definition of labels and IFU
• Relevant regulations of labels and IFU
• Best Practices for labels and IFU compliance and remediation