Jul 21, 2025
In an important step toward protecting public health and consumer trust, the Government of India has introduced new guidelines requiring wel
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In an important step toward protecting public health and consumer trust, the Government of India has introduced new guidelines requiring wel
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CDSCO Classification for Medical Devices: Simplified
Navigating India’s medical device regulations? Here’s the lowdown on CDSCO classification:
✨ What’s CDSCO? India’s regulatory body for medical devices (think FDA but for India).
✨ Risk-Based Classes:
Class A: Low risk (e.g., elastic bandages)
Class B: Low-moderate risk (e.g., contact lenses)
Class C: Moderate-high risk (e.g., blood bags)
Class D: High risk (e.g., heart valves)
✨ Why Register? CDSCO registration is a must for manufacturing, importing, or selling medical devices in India.
✨ Need Help? Regulatory consultants like Operon Strategist can guide you through device classification, documentation, and licensing (MD-15 for imports, MD-41 for wholesale).
Struggling with CDSCO registration of medical devices? Let’s chat!