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...
FDA
The article addresses the aspects related to the approach medical device manufacturers should apply when assessing the actual performance of their products placed on the market in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug...
BfArM
The new article addresses the aspects related to the directory containing information about any and all digital health applications available in Germany. Table of Contents The German regulating authority in the sphere of healthcare products (BfArM) has published a...
CDRH
This blog post will provide an overview of the GUDID, its purpose, how it works, and its impact on the healthcare industry. Table of Contents The FDA’s Global Unique Device Identification (UDI) Database is a pioneering initiative that has revolutionized the...
HSA
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. ...
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