Thailand - Medical Devices Categorised into 8 Standards

Instead of policy-based classification, Thailand is now moving towards a risk-based classification of medical devices for manufacturers and importers.


As compared to policy-based classification which categorises medical devices into 3 groups, namely Licensed Medical Devices, Notification Medical Device and General Medical Devices based on their common names, risk-based classification is done in line with the guideline established by the ASEAN AMDD.


In this case, medical devices are categorises into 8 groups based on the extent of harm they can cause to the body, from the most invasive medical device as class 1 and least invasive ones as class 8.


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