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Thailand Rolls Out IMDRF-Based Risk Classifications For Devices And Diagnostics

 
• By Ashley Yeo

Thailand has opted to align with IMDRF principles on the classification of devices. The change also brings the Thai FDA into line with Asean Medical Device Directive principles.

Thailand

The Thai Food and Drug Administration (FDA) has established a new four-risk class system for classifying medical devices and in vitro diagnostics (IVDs).

The change, published in the Thai Government Gazette on 18 December, at a stroke brings the national regulatory system into closer alignment with International Medical Device Regulators Forum (IMDRF) principles, with the 10-nation group that uses the Asean Medical Device Directive (AMDD) – and the

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