SaMD manufacturers are pleasantly surprised by the speed of market access and sales potential in Vietnam.”

David Vo
General Manager
Asia Actual Vietnam

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    Vietnam Diagnostic Imaging Center Hosts AI Software Conference

    Published on: May 11th, 2023

    On April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam. The day-long event was aligned with the Vietnamese government’s larger strategy to promote the development and adoption of AI-enabled software as part of the Fourth Industrial Revolution.

    Strong attendance and active participation showcased that the use of AI software to improve the efficiency and accuracy of medical imaging diagnosis is embraced by healthcare providers in the country. With willing consumers and an expedited regulatory pathway for SaMD, manufacturers of such devices are advised to consider the Vietnamese market.

    If you have questions about the processing of radiology images via AI Software as Medical Device in Vietnam, or about the current regulatory landscape in the country, feel free to contact us or visit this page our website.

    Conference Details

    The conference program “Update for Testing and Diagnostic Imaging 4.0 in Diagnosis and Treatment” was held at Quinter Hotel in Nha Trang City and attracted the participation of several agencies and departments located in the Khanh Hoa province, including the Deputy Director of Khanh Hoa Provincial Department of Health, along with several radiology manufacturers and a number of doctors and nurses from the South Central Coast Region.

    The program included multiple presentations, from healthcare professionals and academics including an “Update on Remote Imaging Trends and “Digital Conversion Application in Imaging Systems at MEDLATEC.” Further information on the conference can be found at the MEDLATEC website here.

    Information on MEDIM

    The MEDLATEC Diagnostic Imaging Center (MEDIM) is a private institution and one of the most important imaging centers in Vietnam and is working to connect hospitals in the region with up-to-date imaging software as well as local training for healthcare professionals.

    More information on the MEDLATEC Diagnostic Imaging Center can be found here.

    Registration of Software as Medical Device in Vietnam

    The new Vietnamese medical device rules (ref. Decree NO. 98/2021) utilize a risk-based classification system. In specialized treatment, the Ministry of Health deems almost all software as medical device products exclusively as Class B.

    Importantly, applications for all risk class B devices are processed at the provincial level within 5 days. For more details on the registration process in Vietnam visit our website here.

    As AI imaging software becomes more widespread in the region, independent license holders like Asia Actual will be crucial in ensuring regulatory compliance.

    Come Grow with Us

    Please contact us for more information on Software as Medical Device (SaMD) in Vietnam. Asia Actual has an office in Ho Chi Minh City staffed by experienced, bilingual regulatory and commercial professionals to address questions or provide support.

    Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asian markets through registration, independent license holding, direct fulfillment, and a variety of sales channel support services.  

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