May 12, 2022

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).

The HSA published its risk classification structure for software as a medical device (SaMD) in its latest guidance Regulatory Guidelines for Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS). The risk classification framework is based upon the proposed risk classification structure of  Software as a Medical Device, which was drawn up by the International Medical Device Regulators Forum (IMDRF).

New guidance address multiple risks of SaMDs

The new guidelines were finalized after a comment period in which the HSA collected feedback from industry until mid-August 2021. The new rules add clarity to the criteria for clinical decision support software (CDSS) that qualifies as a medical device. The agency also finalized its requirements for SaMDs in its Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach, which clarifies regulatory requirements for SaMDs throughout the product lifecycle.

These guidelines provide clarity on:

  • Software with multiple functions
  • Cybersecurity submission requirements
  • Changes to medical devices incorporating machine learning

Emergo by UL will continue to report on Singapore’s regulatory requirements as they become available.

More medical device regulatory resources for Singapore from Emergo by UL:


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    Kathryn Burke