Vietnam: Overview of the national rule for Software of Medical Devices (SaMD)
As innovation in the life sciences continues worldwide, Asian countries are seeing an increase in the number of new business launches utilizing technologies in the digital health and life sciences fields, as well as acquisitions, reorganizations, venture investments, and licensing transactions targeting such businesses. In May 2023, the Japanese Ministry of Health, Labour and Welfare issued “Guidance for Appropriate and Prompt Approval and Development Based on the Characteristics of Software as Medical Devices”（the “Guidance”）. The Guidance outlines the current pharmaceutical affairs approval system based on the characteristics of Software as Medical Devices （“SaMD”）, as well as a new concept to further accelerate the launch of new products. This guidance is only available in...To read the full article, please see the PDF file
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