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Vietnam - Authorized Medical Device Representative Change

Hi Murni Ahmad

Mr.Supadrai is right. It's quite strict .
Here some info:
1. You have to follow the form issue by MOH (check attache file)
2. Certificated of Warranty for Local Services Center (Check attache file)
3. You should use original FSC. Via new Decree No.36/2016 & Decree No.169/2018, CE is not accepted.
4. ISO 13485 can be use soft copy, no need notarized.
5. The answer depend on your product specification, you can follow template in Decree No.36, CSDT will apply from 1 July 2020

Hope this help.

Vo Trung Viet (David)


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