FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
FDA
The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.
China
In this article, we will provide a comprehensive introduction to Class III medical devices, including what they are, how they are regulated, and what makes them different from other classifications. Whether you are a healthcare professional or simply interested in...
China
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...
