Tag Archive for: SAMD

Vietnam Diagnostic Imaging Center Hosts AI Software Conference

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.

Thailand FDA Publishes Guidance for Software as Medical Device

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.

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.