CDRH
This article highlights the procedure, key points and Benefits of the USFDA eSTAR Submission Programme. Table of Contents eSTAR Submission According to the FDA announcement in September, businesses can now submit premarket applications electronically via the CDRH...
EU MDR/IVDR
This article highlights the importance of GSPR compliance for obtaining medical device approval in the European Market. Table of Contents The European Union (EU) has implemented stringent regulations and requirements for the approval and launch of medical devices...
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...
