Are CDSCO registration valid for every medical device in India?

Yes, all medical devices must be registered with CDSCO, by October 1, 2023.

How long does it take to complete the CDSCO registration?

Usually, 6–9 months. The timeline can vary based on the device type and level of documentation.

How long is CDSCO registration?

CDSCO registration is valid for three years unless revoked or suspended.

Who is eligible to apply for a CDSCO medical device registration?

Domestic manufacturers, importers, foreign manufacturer, authorized agents, or Indian subsidiaries.

What does CDSCO actually do in India?

CDSCO approves and licenses medical devices, drugs, and IVDs, and incurs investigational obligations.

What are the differences between Class A, Class B, Class C, and Class D devices?

These are distinct risk based categories: Class A (Least Risk) to Class D (Highest Risk).

Can foreign manufacturers apply for CDSCO registration?

Yes, foreign manufacturers can apply directly or through Indian Authorized Agents (IAA) or their Indian subsidiary.

Is BIS certification required along with CDSCO registration?

For some of the devices, this is also mandatory for quality and safety.

What is the CDSCO online portal?

The SUGAM portal is the official online portal for CDSCO application submission.

Can I sell my device in India without CDSCO approval?

No, unregistered devices cannot legally be sold or distributed in India.

Medical Device Registration In India | CDSCO Approval Process

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