CDRH
This article talks about USFDA Medical Device Approval Timeline as per their Classification. Table of Contents The process of getting FDA approval for a medical device can be lengthy and complex.The time it takes for a medical device to receive FDA approval can vary...
GMDN
This aticle highlights the importance of Medical Devices in the healthcare industry highlighting their key uses, developments and emerging technologies in the sector. Table of Contents Over the past few decades, there has been a significant evolution in medical...
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...
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...
EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
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