Process and Steps for CDSCO Registration of Class D Medical Devices

1. Preliminary Preparation:

• Understand Classification: Ensure your device is classified as Class D, which is high-risk, including critical devices like implantables.
• Gather Documentation: Collect all necessary documents such as clinical data, manufacturing details, and quality management certificates.

2. Document Preparation:

• Device Information: Detailed description of the device, its function, and intended use.
• Clinical Evaluation: Clinical data demonstrating the safety and efficacy of the device.
• Manufacturing Details: Information on the manufacturing site, process, and compliance with Good Manufacturing Practices (GMP).
• Quality Management System: ISO 13485 or equivalent certification for manufacturing quality.
• Labeling: Device labeling and instructions for use compliant with Indian regulations.

3. Online Application:

• Register on SUGAM: Create an account on the CDSCO SUGAM portal.
• Complete Forms: Fill out the application forms provided on SUGAM with detailed device and manufacturer information.
• Upload Documents: Upload all required documents, including clinical data, device description, and quality certificates.

4. Fee Payment:

• Submit Fees: Pay the registration fees through the SUGAM portal. The fee amount depends on the device category and classification.

5. Review Process:

• Document Review: CDSCO will review the submitted documents for completeness and accuracy.
• Additional Information: CDSCO may request additional information or clarification if necessary.

6. Inspection (if applicable):

• Manufacturing Site Inspection: For high-risk devices, CDSCO may conduct an inspection of the manufacturing facility to ensure compliance with GMP.

7. Approval and Registration:

• Issuance of Certificate: After successful review and inspection, CDSCO will issue a registration certificate for the device, allowing it to be marketed in India.

8. Post-Approval Compliance:

• Ongoing Reporting: Adhere to post-market surveillance requirements, including reporting adverse events and any changes to the device or its manufacturing process.
• Renewal: Ensure timely renewal of registration as per CDSCO guidelines.

Key Points:

• Compliance: Ensure adherence to all CDSCO guidelines and regulatory requirements.
• Documentation: Accuracy and completeness of documentation are crucial for a smooth approval process.
• Consultation: Consider professional advice from regulatory experts if needed.

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