The Thai Food and Drug Administration (FDA) has announced its intentions to implement a risk-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.

Contact Asia Actual to register medical devices in Thailand under the new risk-based medical and IVD device classification system.