![HSA Consultation on Risk Classification of Standalone Medical Mobile Applications (SaMD)](https://www.regdesk.co/wp-content/uploads/2021/08/HSA-Consultation-Risk-Classification-of-Standalone-Medical-Mobile-Applications-1080x675.png)
Aug 11, 2021
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...
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![FDA Policy on Software Functions](https://www.regdesk.co/wp-content/uploads/2021/08/Policy-on-Software-Functions-1-1080x675.png)
Aug 10, 2021
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...
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![IMDRF Framework for SaMD Quality Management System](https://www.regdesk.co/wp-content/uploads/2019/05/software-erp-1080x675.jpg)
Oct 16, 2020
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...
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![IMDRF Framework for SaMD Quality Management System](https://www.regdesk.co/wp-content/uploads/2019/05/software-erp-1080x675.jpg)
Oct 13, 2020
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...
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![Software Pre-certification Pilot Program (Pre-Cert)](https://www.regdesk.co/wp-content/uploads/2019/06/1_4sc9_oAz754fPuD6JHpNGQ-1080x675.jpeg)
Jun 5, 2019
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...
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