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

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

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

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

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

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

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

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

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

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