CDSCO Test License for Medical Devices in India
Chapters IV and V of the MDR 2017 provide detailed guidelines for manufacturers and importers seeking to manufacture or import small quantities of medical devices for […]
NSWS portal: A Single Window for Central Government Approvals
The Central Government has launched the National Single Window System (NSWS) portal for businesses/investors seeking to enter or operate in
CDSCO Approval Process for Medical Devices without predicate in India
The Indian medical device market is growing rapidly, and the current medical device market size is estimated at $11 billion
Ensuring Quality in Healthcare: The Role of BIS Standards for Medical Devices
Introduction: In the ever-evolving landscape of the healthcare industry, ensuring the quality and safety of medical devices is paramount. To
6-Month Extension Announced for Class C and Class D Medical devices
On October 12, 2023, the CDSCO released a circular, extending the deadline by six months for manufacturers and importers dealing
WPC ETA Certification – Must for Wireless Medical Device
Introduction: Medical devices incorporating wireless technologies require WPC Equipment Type Approval (ETA) certification to be imported or sold in India.
The Vital Role of Post-Marketing Surveillance for Medical Devices
Introduction: The use of medical devices has improved healthcare enormously. However, like any technology, medical devices also carry risks. These
Medical Device Labelling: Ensuring Clarity and Safety
Introduction: In the world of healthcare, medical devices play a crucial role in diagnosis, treatment, and patient care. At the
Medical Device Grouping: An Effective Regulatory Approach
Introduction : In the dynamic world of medical devices, regulations play a critical role in ensuring patient safety and product