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China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739
The session will cover the evolving regulations related to the main changes by China NMPA in support of its overarching policy, Order 739, “Regulation on the Supervision and Administration of Medical Devices”. It will review the impact on clinical evaluation pathways, clinical evaluation principles and processes, clinical evaluation reports and data appraisal, Good clinical practice (GCP) and Clinical trial permission (CTP). There have been significant updates as part of the continuous China NMPA regulatory transformation process.
This webcast will review Order 739 from China State Council which covers the complete product life cycle with a positive direction to more efficient and less burdensome approval process. Attend this live broadcast to learn the key highlights of clinical evaluation and clinical trial related changes and updates.
- Understand the new framework and key clinical evaluation changes for writing CER with the implementation of Order 736
- Learn to use more versatile clinical evidence to support clinical evaluation and fast approval pathways for urgent use/innovation
- Learn how to conduct clinical evaluations and how to prepare clinical evaluation reports
- Understand how to demonstrate equivalence
- Learn methods for determining if clinical trials are necessary