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医療機器規制が激動するASEAN諸国 ~タイ~ Thailand starts new regulation in a whirlwind of Medical Device Re




ASEAN region is moving forward to align the Medical Device Regulation by 2020.

It is underway to achieve that goal. However now Thailand starts new regulation, which was open on May 1, 2019.




(CSDT: Common Submission Dossier Template)






・Classification is made from 1 to 4

・Class1: Notification

・Class2 to 4, CSDT will be used.(CSDT: Common Submission Dossier Template)

・The valid period of approval certificate is 7 years.

・Preferential treatment for marketing items;

  Simple review to shift the approval under the new regulation.

  The acceptable country: Japan, USA, EU, Canada, Australia

・Labeling needs Thai language