CDSCO Medical Device Registration in India: A Complete Guide
The Central Drugs Standard Control Organization (CDSCO) governs the registration of medical devices in India. As the medical device industry grows, understanding the CDSCO process becomes essential. This blog provides a concise overview of the CDSCO registration process, its importance, and key steps involved. Understanding CDSCO and Its Role CDSCO, under the Ministry of Health […]
PMS Reports: Ensuring Ongoing Device Safety
Introduction: Post-Market Surveillance (PMS) is a crucial aspect of the medical device lifecycle, ensuring that devices remain safe and effective even after they have been released to the market. This blog will explore the key components and significance of PMS reports, accompanied by relevant images to enhance understanding. What is a Post-Market Surveillance (PMS) Report? […]
“EUDAMED Compliance: Navigating the New Era of Medical Device Regulation”
EUDAMED and its role in the EU Medical Device market EUDAMED, the European Database for Medical Devices, is a critical component of the European Union’s regulatory framework for medical devices. It serves as centralized hub for comprehensive information on medical devices available within the EU market. The primary role of the EUDAMED is to enhance […]
Streamlining Approvals: CDSCO Notice on NSWS Portal Implementation
Welcome to our latest update on the groundbreaking changes in regulatory processes. We are excited to share that the Central Drugs Standard Control Organization (CDSCO) has recently issued a notice, effective January 1, 2024, introducing the National Single Window System (NSWS) Portal. This development aims to revolutionize the approval processes for investors, promoting efficiency and […]
