Digital health has revolutionized the healthcare sector. Artificial intelligence (AI) and machine learning (ML) have gained widespread recognition because of their promising benefits in enhancing diagnosis, decision making, and treatment capabilities. A robust regulatory framework is essential for Al/ML-enabled medical devices to balance innovation while safeguarding public health. This article provides an overview of the global regulatory landscape for AI/ML-enabled medical devices, focusing on the framework in the US, EU, Canada, UK, Singapore, China, Hong Kong, Brazil, South Korea, Australia, and the International Medical Device Regulators Forum (IMDRF).
Digital health has revolutionized the healthcare sector. Artificial intelligence (AI) and machine learning (ML) have gained widespread recognition because of their promising benefits in enhancing diagnosis, decision making, and treatment capabilities. A robust regulatory framework is essential for Al/ML-enabled medical devices to balance innovation while safeguarding public health. This article provides an overview of the global regulatory landscape for AI/ML-enabled medical devices, focusing on the framework in the US, EU, Canada, UK, Singapore, China, Hong Kong, Brazil, South Korea, Australia, and the International Medical Device Regulators Forum (IMDRF)…
