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- Device Description: Detailed information about the device’s design, intended use, and functionality.
- Verify that your device is correctly classified as a Class B device, which includes moderate-risk devices.
- Online Application: The primary platform for submitting applications is the CDSCO SUGAM portal. It is an online system where you can submit your application, upload required documents, and track the status of your application.
- Application Fee: The application fee for CDSCO registration of Class B medical devices typically ranges from ₹10,000 to ₹25,000. The exact fee can depend on the type of device and the nature of the application.
- Class B Device: Confirm that your device is classified as Class B, which typically includes moderate-risk devices. The classification determines the level of regulatory scrutiny.
- Identify Classification: Ensure your device is correctly classified as Class B. This classification includes devices that pose a moderate risk to the patient but are not as high-risk as Class C or D devices.
- Document Preparation: Compile documents such as a product dossier, labeling, clinical evidence (if applicable), risk analysis, and manufacturing details.
- Prepare Documentation: Gather all necessary documents including product details, labeling, intended use, manufacturing process, and safety data.
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