Singapore – Singapore issues new guidance for software as a medical device

As software has begun to have an increasingly important role in many medical devices that rely on it for safe and effective function, Singapore’s Health Sciences Authority (HSA) has rolled out several new policies governing medical mobile applications that are considered medical devices.

The increasing role of software in medical devices spurs need for new guidelines

Medical device makers in Singapore will want to keep abreast of the new requirements that may affect obtaining or maintaining market access for their products. Singapore’s regulatory agency announced a new risk classification structure and regulatory rules to address the complex challenges that using software in clinical applications poses, including interoperability, Artificial Intelligence (AI) and the Internet of Things (IoT)…