DCGI has made it mandatory for all manufacturers and importers who have obtain new drug permission to submit Periodic Safety Update Reports of new drug every six months for the first two year and for the subsequent two years it should be submitted annually
“DCGI has made it mandatory for all manufacturers and importers who have obtain new drug permission to submit Periodic Safety Update Reports of new drug every six months for the first two year and for the subsequent two years it should be submitted annually”.
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications...
The future of Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring...
Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device...
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