2021 is a big year for China NMPA reformation. With the implementation of decree Order 739, “Regulation on the Supervision and Administration of Medical Devices”, tens of new regulations and major updates in the forms of policies, guidelines, standards, and announcements were released in 2021. These significant updates and changes have impacted the complete product life cycle of medical device, IVD, companion diagnostic and combination products from new submissions, renewals to post market surveillance. One of the big improvement from China medical device regulators—the NMPA began to recognize self-test report from manufacturers. They have published new guidelines on the qualifications for self-test reports along with the submission requirements. There are big changes in clinical evaluation as well specifying CER writing requirements and how to determine when to do clinical trial etc. The new GMP submission requirements are added to the e-Filing catalogue.
 
In this webinar, you will get a brief idea about how to be proactively prepared to shorten their time to market for new submissions with these rapid changes. Above all, how to stay compliant after your approval to meet China post market compliance as well hospital reimbursement code requirements.
Topics:

• Key Highlights of Order 739: New law, regulation, policy, standards & guidelines
• New Perspective on Clinical Evaluation Pathways: clinical evaluation decision tree, overseas clinical data acceptance, clinical trial or not, piloted real-world data
• IVD & Combination Device
• 2 Geographic Pilot Zone-Great Bay Area & Hainan: NMPA un-approved devices use in China
• PMS/QMS(NHSA code, AE, Recall & Overseas Inspection)
• Look ahead to 2022