- Download 235
- File Size 0.00 KB
- File Count 1
- Create Date June 28, 2021
- Last Updated January 6, 2022
Navigating China's New Regulatory Policy: Order 739
China’s regulations for medical technologies are undergoing a significant revision with implications for the entire product lifecycle. The new regulatory framework (Order 739 / Regulations for the Supervision and Administration of Medical Devices) went into effect on June 1, with several follow-on regulations to be issued in the coming months. This webinar will provide an in-depth overview of the key changes to product registration and post-market surveillance, helping your company to take advantage of new approval pathways and avoid possible penalties.
- Grasp the key content of Order 739 and its changes across the entire product lifecycle.
- Glean the most significant benefits for multinational corporation manufacturers, such as NMPA’s acceptance of a self-test report or third-party test reports; the establishment of special geographic regions within China where non-approved devices can be used, etc.
- Discover how clinical evidence can be leveraged in more versatile ways to support clinical evaluation.
- Become familiar with fast-track approval pathways for cutting-edge innovations and products intended for emergency use.
- Learn how to avoid penalties as post-market monitoring will become more stringent.