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Navigating China’s New Regulatory Policy: Order 739
June 28, 2021 @ 8:00 pm – 9:30 pm
Register on Event Website 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. Join us for our webinar with Sidley Austin and China Med Device on June 28 from 8:00 PM – 9:30 PM ET / June 29 from 8:00 AM – 9:30 AM China time for a comprehensive overview of China’s new regulatory policies. Learning objectives for attendees:
- 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.