Tag Archive for: classification

Thailand FDA Publishes Guidance for Software as Medical Device

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On December 12th, the Thai FDA published guidance to assist with the determination of medical device status and risk classification for medical device software in Thailand.

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Singapore’s HSA Removes Classification and Grouping Inquiry Option

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Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.

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