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