Under rule 122 DD Registration of Ethics committee (EC) – No ethics committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee
Under rule 122 DD Registration of Ethics committee (EC) – No ethics committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee with the licensing authority as defined in clause (b) of rule 21. An application for registration of Ethics Committee shall be made to the licensing authority in accordance with the requirements prescribed in schedule Y-1.
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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