The Ministry of Health and Family Welfare (Department of Health and Family Welfare) under the Government of India, on 18th January 2022, G.S.R.78 (E) released an official gazette with a few new rules on the import of medical devices in India, and the final amendment of this rule G.S.R.174 (E) was released on 4th March 2022.
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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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