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An overview of the medical device regulations in Vietnam (August 2019) £ 50.00 Since 2016, Vietnamese authorities have issued many new legal documents on medical devices, and the current regulations on medical device management in Vietnam are quite comprehensive and clear for manufacturers, importers and distributors to apply in their activities.
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Oct 08, 2018 · Medical Device Registration in Vietnam, Certificate of Free Sale, DMEC freyrsolutions Regulatory services October 8, 2018 October 8, 2018 1 Minute Freyr provide Medical Device registration in Vietnam, risk classification, Local authorized representation, support in Free-sale Registration Number (FRN) Procurement & Linguistic Translation to ... Classification of medical devices. The GHTF documents state that “regulatory controls should be proportional to the level of risk associated with a medical device.” 4, 5 To enable assessment of the level of risk, and therefore apply the correct regulations, medical devices are divided into different classes (Table 1).
Vitamin d deficiency redditMEDICAL DEVICE REGULATION IN VIETNAM Medical devices are regulated by the Department of Medical Equipment and Construction (DMEC) from the Ministry of Health in Vietnam. Medical devices are regulated under different Circulars. · For importing of medical devices by the Vietnamese traders and the importers, Circular No. 24/2011/TT-BYT.
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Vietnam medical device regulations

 

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