The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory ...
“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...
DCGI releases classification of 77 medical devices related to oncology: Gireesh Babu, New Delhi Wednesday, January 7, 2026, 08:00 Hrs [IST] As part of its efforts to regulate the ...
The European Union has released two significant guideline changes to expand its medical device framework, updating the classification rules for medical device software to include app platform ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...
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