The EU AI Act introduces a new compliance layer for AI-enabled medical devices in Europe. It requires manufacturers to meet both EU MDR/IVDR and AI Act obligations. High-risk AI medical devices must now address AI-specific requirements, such as data governance, risk...
Home healthcare devices are medical tools designed for use at home to monitor, manage, and support health conditions. They are especially useful for elderly care, chronic diseases, such as diabetes or hypertension, and post-COVID recovery. In India, popular home...
QMS certification training for medical devices is a professional course that teaches participants how to understand, implement, and audit QMS. The training typically covers regulatory requirements, risk-based thinking, documentation practices, and internal/external...
India–UK FTA, effective July 15, 2026, introduces mutual regulatory recognition for medical devices. Additionally, it removes tariffs on Indian exports, such as surgical instruments, diagnostic equipment, ECG machines, and X-ray systems. This means Indian...
CDSCO is the apex regulatory body for cosmetics in India. Thus, all cosmetics and their variants will have to be registered with the CDSCO to be launched in India. Under CDSCO, cosmetic variants are defined as differences in shade, fragrance, flavour, or pack size of...