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

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

How to Apply for Medical Device Registration on SUGAM Portal (Step-by-Step Guide 2026)

If you’re planning to manufacture, import, or sell medical devices in India, there’s one platform you cannot bypass — the SUGAM Portal.

How to Apply for Medical Device Registration on SUGAM Portal — Complete Step-by-Step Guide 2026

If you are a medical device manufacturer, importer, or Authorised agent planning to enter the Indian market, most CDSCO applications are processed

Medical Device Import License India – Everything a Foreign Manufacturer Needs to Know

India’s medical device market is one of the most attractive in the world — a rapidly expanding healthcare sector, a government pushing

CDSCO Medical Device Registration: Documents Required for Class A, B, C & D Devices

If you’re planning to enter the Indian medical device market, dealing with the Central Drugs Standard Control Organization (CDSCO) is unavoidable. And