Tag Archive for: SAMD

Singapore’s HSA Issues New Software as Medical Device (SAMD) Guidance

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.

NMPA Issues New Guidance for Medical Device Software in China

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

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

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.