Mandatory EUDAMED implementation from 28 May 2026: How must EU medical device and IVD manufacturers prepare?
European database on medical devices (EUDAMED) is the digital backbone for regulatory oversight across the EU medical device and IVD ecosystem. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED will be...
10 Common Reasons for US FDA Submission Denials to Avoid
The U.S. Food and Drug Administration (FDA) serves as the primary regulatory authority for medical devices in the United States. It is responsible for protecting public health. The U.S. FDA accepts several types of submissions depending on the product category, risk...
Checklist for CDSCO Import License for Medical Devices: MD 15
Navigating the CDSCO medical device import license (MD 15) application process can be cumbersome and tricky. Any missteps or lapse in application can lead to application delay or rejection. Hence, we have prepared this checklist for CDSCO import license for medical...
CDSCO Medical Device License Application Guide for First Time Applicants
Medical devices have a pivotal role in the healthcare industry. These devices are used to diagnose, monitor, and treat patients. In India, the Central Drugs Standard Control Organization (CDSCO) regulates and controls all medical devices entering its market. A CDSCO...