CDSCO Regulations for Manufacturing Home Healthcare Devices
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...
What is QMS Certification Training for Medical Devices?
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 Opens Door for MedTech Industry Growth with Regulatory Recognition
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...
An 8-Step Comprehensive Guide to EU IVDR Compliance
In vitro diagnostics (IVDs) are devices used to perform tests outside the human body on samples, such as blood, urine, or tissue. They are used to detect diseases, monitor health, and guide treatment decisions. They play a crucial role in healthcare by enabling early...