Tag: Software as a Medical Device

Medical Devices-Asia and ROW Regulatory News – April 2023

April 18, 2023
Medical Device

ASIA INDIA (CDSCO) Circular for Licensing of Class C & D medical devices According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, SaMD, Software as a Medical Device

Regulatory Changes for Software Based Medical Devices in Australia

August 20, 2021
Medical Device

The Therapeutic Goods Administration (TGA) regulates software-based medical devices; including software that functions as a medical device in its own right, and software that controls or interacts...

Medical device labelling requirements, regulatory guidance, Software as a Medical Device, Software Based Medical Devices in Australia, Therapeutic Goods Administration (TGA)

SaMD Regulatory Landscape in the US and Europe

August 13, 2021
Standards

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis...

compliant with good clinical practice, Digital Health, how the regulatory landscape is changing, Navigating a complex regulatory environment, Software as a Medical Device, the regulatory landscape for SaMD