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Vietnam: Overview of the distribution rule and advertising regulations for medical devices

In our 5 July 2023 newsletter, we focused on the status of Software as a Medical Device (“SaMD”) in relation to medical device classification in Vietnam. That is, in Vietnam, SaMD will be regulated as a medical device if it meets the requirements for medical devices. In this newsletter, we would like to briefly introduce the following two topics; (i) licensing requirements for the importation and sale of products from outside Vietnam that are categorized as medical devices in Vietnam and (ii) an overview of the regulations on advertising for the sale of medical devices in Vietnam. If a medical device is planned to be imported and distributed in Vietnam from outside Vietnam, the...To read the full article, please see the PDF file

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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.