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.
https://asiaactual.com/wp-content/uploads/2017/03/logo2.png 0 0 AsiaActualAdmin https://asiaactual.com/wp-content/uploads/2017/03/logo2.png AsiaActualAdmin2016-05-31 21:53:092017-04-24 21:56:59Thailand to Implement New Medical Device Classification System