Class C medical devices are those with a higher risk and complexity, such as implants or devices used in critical care. To apply for Class C medical device registration with CDSCO in India:

1. Understand Classification: Verify that your device falls under Class C according to the CDSCO classification system.

2. Prepare Documentation: Gather all required documents, including:

   • Technical file
   • Clinical evaluation report
   • Risk management file
   • Manufacturing and ISO certifications
   • Labels and packaging information

3. Online Application: Register on the CDSCO SUGAM portal and complete the application form.

4. Submit Fees: Pay the registration fee as per CDSCO's fee structure.

5. Upload Documents: Submit all necessary documents and information through the SUGAM portal.

6. Review Process: CDSCO will review the submission. They may request additional information or conduct inspections.

7. Approval: After a successful review, CDSCO will grant the registration certificate.

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