SaMD is confronted with numerous regulatory obstacles, such as those related to data security, validation, and classification. SaMDs must undergo stringent validation to prove their safety and efficacy, and the FDA divides them into risk-based classes (Class I, II, III, and IV).
Software updates make oversight more difficult and necessitate continuous monitoring and post-market surveillance,...
In a major move to boost regulatory efficiency, the Central Drugs Standard Control Organization (CDSCO) has added new forms to the National Single Window System (NSWS) portal. This enhancement is poised to streamline processes for pharmaceutical companies, making compliance with regulatory requirements smoother and more efficient.
The National Single Window System (NSWS) is an innovative...
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