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
Understanding the Validity and Renewal of CDSCO Medical Device Import License
Introduction : As per the Medical Device Rule, 2017, the medical device import license in India needs to be renewed
Transitioning to Full Licensing: Class C and D Medical Devices in India
Introduction: On April 12, 2023, the Central Drugs Standard Control Organization (CDSCO) of India released a circular reminding Indian manufacturers and importers