To apply for CDSCO registration for Class D medical devices in India, follow these steps:

1. Prepare Documentation: Gather required documents, including product details, clinical data, manufacturing information, and quality management system certificates (ISO 13485).

2. Apply Online: Submit your application through the CDSCO’s online portal, SUGAM. You’ll need to create an account and fill out the relevant forms.

3. Submit Fees: Pay the applicable fees for registration, which vary based on the device and its classification.

4. Review Process: CDSCO will review the submitted documents and may request additional information or clarification.

5. Inspection and Approval: If necessary, an inspection of the manufacturing site may be conducted. Upon successful review and inspection, CDSCO will issue the registration certificate.

6. Post-Approval Compliance: Ensure ongoing compliance with Indian regulations, including adverse event reporting and renewals.

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