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Navigating SaMD Registration Requirements: China & US Perspectives

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  • Create Date May 28, 2024
  • Last Updated July 8, 2024

Navigating SaMD Registration Requirements: China & US Perspectives

Join our webinar to gain insights into the evolving regulatory landscape for Software as a Medical Device (SaMD) products in both the China NMPA and the U.S. FDA. As digital health technologies continue to advance, SaMD has emerged as a significant sector in the medical device industry. In the U.S., the FDA has been actively developing a regulatory framework to ensure the safety and effectiveness of SaMD, while in China, the NMPA is also making strides in establishing regulations that align with its unique healthcare ecosystem.
Our expert speaker will delve into the key requirements, processes, and approval criteria for SaMD products in these two largest Medtech markets in the world, providing you with a comprehensive understanding of the nuances and complexities involved in navigating these regulatory environments.
After this 60-minute webinar, you will have a practical understanding of the following areas about SaMD registration in China NMPA and US FDA:
• General regulatory landscape of SaMD
• SaMD Key Regulations and Standards
• Specific SaMD classification and naming rules
• General of Requirements of SaMD Registration
• Clinical Evaluation Requirements

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