The Therapeutic Goods Administration (TGA), the division of the Australian Department of Health responsible for medical device regulation, issues guidance on IVD companion diagnostic devices. Definition of IVD Companion Diagnostics According to the guidance,...
The European Commission has announced the extension of the application period for medical device and in vitro diagnostic device expert panels. It is intended that experts will be able to provide technical and scientific advice in regards to applications and medical...
What is IVD/IVDR In Vitro Diagnostic (IVD) medical devices are intended for examining specimens of the human body to either provide information on the physiological state of the patient or to monitor therapeutic measures. They could also be used to define the...
The Medical Device Rules, 2017 went into effect the beginning of this year, January 2018. Though the Act comprehensively covers “medical devices”, it failed to providing details for In Vitro Diagnostic devices (IVDs), digital health products, and software...