Tool for advising on procedures for the circulation of medical devices in Vietnam.

To begin, please select the type of medical equipment below.

GENERAL MEDICAL DEVICES

MEDICAL DEVICES (IVD)

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BACK RESTART

The Medical Device Risk Classification tool here has been localized and designed by MEDNOVUM Vietnam to comply with the detailed regulations on medical device classification issued by the Vietnamese Ministry of Health in Circular 39/2016/TT-BYT dated October 28, 2016.

By correctly answering the True/False questions of this Logic Tool, you will know whether the medical device you are interested in is classified as risk level A, B, C, or D when circulating in Vietnam. To obtain a useful answer, you need a basic understanding of the technical specifications and designated usage of the device to be classified and to answer the Tool's questions as best as possible.

Although we have made every effort to ensure the accuracy of the information, we do not assume responsibility for the classification results of this Tool. In case official results are required for the purpose of preparing, drafting import documents or marketing authorization, please contact MEDNOVUM for consultation with our experts.

Thanks!