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- Initial Processing: Upon submission of your application through the SUGAM portal, CDSCO typically acknowledges receipt and begins the initial review. This can take about 2 to 4 weeks.
- Class C Classification: Ensure your device is correctly classified as Class C based on CDSCO guidelines. Class C devices are high-risk devices that require more stringent controls compared to lower-class devices.
- SUGAM Portal: The application for Class C medical device registration is submitted through the CDSCO SUGAM portal. Access the portal here: SUGAM Portal.
- Device Description: Detailed description of the device including its intended use, design, and mode of action.
- Classify Your Device: Ensure your device is classified as Class C based on CDSCO guidelines.
- Online Application: Submit your application through the CDSCO's online portal, known as the SUGAM portal. This is the primary platform for medical device registration and other regulatory submissions.
- 2024-08-29Class C Device Registration Fee: Typically ranges from ₹50,000 to ₹1,00,000 or more. The exact fee depends on the type and complexity of the device. This fee is payable online through the SUGAM portal.
- SUGAM Portal: Complete the application form on the CDSCO SUGAM portal, which is the online system for medical device registrations.
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