Hong Kong’s Medical Device Division has released a new technical reference document related to software medical devices (SaMD and SiMD). Released on December 29, 2023, TR-007: Software Medical Devices and Cybersecurity, aims to provide more clarity for Software in a Medical Device (SiMD) and standalone software (Software as a Medical Device (SaMD)), specifically related to definitions, classification and cybersecurity.
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.
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.
Thai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.
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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