Infograph of the timelines for obtaining the registration for medical devices and IVD in India. The registration shall be on voluntary basis for a period of eighteen months (1st April 2020 to 30 Sep 2021), from the commencement of this rule, after which (from 01 October 2021), it shall be compulsory.
Summary Short Description Strict regulatory protocols govern clinical investigations for medical devices. Central to this process are forms MD-22 and MD-23. Form MD-22 is an application to Central Lic..
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...
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