European Union Medical Device Regulation (EU MDR) 2017/745 is a framework governing safety and performance of medical devices in EU. It came into full effect on May 26, 2021, replacing the previous Medical Device Directive (MDD). It aims to address gaps in oversight...
Magnetic Resonance Imaging (MRI) is an excellent non-invasive diagnostic imaging tool. It is used for detection of various diseases by providing precise contrast resolution. Additionally, it is used for treatment monitoring. MRI uses a sophisticated technology....
India is aiming to locally manufacture and assemble medical devices. Various components and parts have to be imported to manufacture life-saving medical devices. However, while importing medical device components and essential parts, medical device manufacturers are...
In this blog, we have provided an overview of what is medical device equivalence. Additionally, we have discussed the criteria and requirements that have to be fulfilled. Moreover, we have highlighted the common challenges encountered while trying to prove...
CDSCO registration is needed to prevent spurious inferior quality medical devices from entering the Indian health care market. In this blog, we will focus on organ preservation solution that has been designated as a medical device by the CDSCO. We will delve into the...