The Thai FDA has announced its intentions to implement a risked-based medical and IVD device classification system toward harmonization with ASEAN MDD guidelines. The new four-tiered system is to take effect in September of 2016 and will replace the current classification system. At that time, Class D, C, and B devices will require CDST files in support of their product registration applications. The change will represent an increased regulatory burden for all but Class A devices.
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