Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has initiated a public consultation on the risk classification of standalone medical mobile applications (SaMD) and qualification of clinical decision support...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document describing the current policy for device software functions and mobile medical applications. The scope of the...
IMDRF
The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities collaborating on the improvement of the existing legal framework, has developed detailed proposals related to the application of quality...
IMDRF
In the course of continuous improvement of the regulatory framework for software as a medical device (SaMD), the International Medical Device Regulators Forum (IMDRF) has developed a new approach to SaMD risk categorization and corresponding consideration. The...
North America
Pre-cert Program, or also known as the Software Precertification Pilot Program (Pre-Cert), was first mentioned in the FDA’s Digital Health Innovation Action Plan. The purpose of this pilot program is to create a foundation for digital health regulation that is able to...
