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Design & Development
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December 11, 2018
The AMDTC is working on the following two key work items:
Classification of products as Medical Device or Non-Medical Device in the different ASEAN Member States (AMS);
Risk classification of identified medical devices with a view to align among the AMS.
The 4th AMDTC Meeting discussed on the classification of a list of 55 products as MD or Non-MD.
Out off 55 products identified, the classification of 39 products as MD or Non-MD were harmonized among the AMS
List of the classification decisions has been endorsed at the 7th AMDC Meeting and will be published on the ASEAN website.
The 4th AMDTC Meeting discussed on the risk classification of a list of 55 medical devices
Out of 55 medical devices discussed, the risk classification of 44 medical devices were harmonized among the AMS
List of these risk classification decisions has been endorsed at the 7th AMDC Meeting and will be published on the ASEAN website in Q1 2019.
Below is a table of "Year of Ratification" by the AMS to AMDD:
This table is referenced from the AMDC Meeting.
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EUDAMED delay for 2 years
November 7, 2019
Central and South America