The European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance deadlines are just around the corner. However, with the transition or ‘standstill’ period ...

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 ...

The Asian economy has experienced tremendous gross domestic product (GDP) growth over the past decade and is expected to continue at a healthy pace for the next several years. The medical device ...

The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, ...

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 ...

“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, ...