August 2021

Vietnam introduces Common Submission Dossier Template

Vietnam to introduce the Common Submission Dossier Template

The Ministry of Health in Vietnam will officially require the use of the Common Submission Dossier Template (CSDT) for all new class B, C, and D medical device registrations as of 01 January 2022. This requirement was published in Decision No. 2426/QDBYT on 15 May 2021 and came into effect immediately. The Decision contains a …

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Singapore HSA consultation Software as a Medical Device

Singapore HSA consultation on Software as a Medical Device Classification

The Singapore Health Sciences Authority (HSA) has issued draft regulatory guidelines on the Classification of Software as a Medical Device that are open for consultation by stakeholders. Comments may be submitted until 19 August 2021. The draft guidelines cover the classification of non-IVD standalone mobile medical device applications commonly known as Software as a Medical …

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