Tag Archive for: SAMD

Vietnam Diagnostic Imaging Center Hosts AI Software Conference

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On April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam.

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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 Issues New Software as Medical Device (SAMD) Guidance

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In April 2022, Singapore’s Health Science Authority (HSA) issued new guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore.

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NMPA Issues New Guidance for Medical Device Software in China

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In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.

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South Korea Releases Guidance for Software using Big Data, AI, and Machine Learning

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The South Korean regulator, the Ministry of Food and Drug Safety (MDFS), recently released multiple guidance documents related to software using AI, Big Data and Machine Learning.

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