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Navigating China’s New Regulatory Policy: Order 739

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  • 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.

Event Link: Navigating China’s New Regulatory Policy: Order 739

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