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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Authors

Takuya MIMA

Associate
Tokyo

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NGUYEN Thi Thanh Huong

Partner
Hanoi / Ho Chi Minh City

Huong started her career at leading local and regional law firms with diversified national and international practices. In 2009, Huong began pursuing a master’s degree from the University of Melbourne, and after doing so, continued her legal career at a number of law firms. Her areas of expertise include M&A transactions, labor law, corporate law, real estate transactions, restructuring and insolvency, and compliance. Huong often advises clients on cross-border M&A deals in relation to real estate, banking and finance, services, and manufacturing. She also regularly supports clients in regard to the formation and registration of internal labor regulations, dealing with labor disputes, labor contract performance, and retrenchment. In addition, Huong assists clients with the incorporation, operation, restructuring, and termination of their businesses in Vietnam, including with respect to day-to-day commercial business, corporate governance, and compliance. In these areas, clients value her extensive experience and detailed knowledge of local laws and culture, as well as her timely, responsive, and effective support.

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