ELT Team, Author at Medical Device Registration | CDSCO Certificate Consultancy

What is Post-Marketing Surveillance of Medical Devices in India?

Getting a medical device approved is only half the job. What happens after the product is in the market is equally important

Clinical Evaluation for Medical Devices — EU MDR Guide for Indian Manufacturers Targeting European Markets (2026)

Clinical Evaluation for Medical Devices — EU MDR Guide for Indian Manufacturers Targeting European Markets (2026) India exported over USD 3.5 billion

In Vitro Diagnostic Devices — IVD Regulation Guide for India, EU & USA

In vitro diagnostic (IVD) devices are essential tools for disease detection and clinical decision-making — from rapid antigen tests and glucose monitoring

CE Certification for Medical Devices — Complete EU MDR Guide 2026

The European medical device market is one of the largest and most highly regulated healthcare markets in the world. Any company planning

Biocompatibility Testing for Medical Devices — ISO 10993 Guide for Manufacturers

Biocompatibility testing is one of the most critical regulatory requirements for medical devices that come into direct or indirect contact with the

US FDA Medical Device Classification — Class I, II & III Explained Simply

If you are planning to enter the US medical device market, understanding FDA device classification is one of the first and most

What Is FDA 510(k) Clearance? A Complete Guide for Indian Medical Device Exporters

India exported over $3.5 billion in medical devices in FY2025–26 — and the United States remains the single largest destination. For Indian

What Is UDI and Will It Be Mandatory in India? — What Medical Device Importers Need to Know in 2026

If you are importing medical devices into India, you have probably started hearing more about UDI — Unique Device Identification. And in

CDSCO 2025 Updates — New Devices Added to Mandatory Registration List: What Manufacturers and Importers Must Know

India’s medical device regulatory landscape changed significantly through 2024 and 2025 — and the pace of change is not slowing down. For

Medical Device License Renewal in India — When to Start, What’s Needed, and What Happens if You Miss the Deadline

Getting a medical device license in India is one milestone. Keeping it valid is a completely different discipline — and one that