How to Apply for CDSCO Registration of Class D Medical Devices

1. Prepare Required Documentation:

• Device Description: Detailed information about the device, including its intended use, design, and technology.
• Clinical Evaluation: Clinical data demonstrating the safety and effectiveness of the device.
• Manufacturing Information: Details of the manufacturing site and compliance with Good Manufacturing Practices (GMP), typically proven by ISO 13485 certification.
• Quality Management System (QMS) Certification: ISO 13485 or equivalent certification.
• Labeling and Instructions for Use: Product labels and detailed usage instructions.
• Technical Documentation: Device Master File, including design specifications, manufacturing processes, and risk management data.
• Additional Documentation: Import license (if applicable) and ethics committee approval (if applicable).

2. Register on the CDSCO SUGAM Portal:

• Create an Account: Visit the SUGAM Portal and register for an account if you don’t already have one.

3. Complete Application Forms:

• Fill Out Forms: Complete the online application forms on the SUGAM portal with detailed information about your device and the manufacturer.

4. Upload Documents:

• Submit Documentation: Upload all required documents to the SUGAM portal. Ensure that documents are formatted and sized according to the portal’s specifications.

5. Pay Fees:

• Submit Fees: Pay the registration fees through the SUGAM portal. The fees vary based on the device classification and specific requirements.

6. Application Review:

• Monitor Status: After submission, monitor the status of your application through the SUGAM portal. Be prepared to provide additional information if requested by CDSCO.

7. Site Inspection (if applicable):

• Prepare for Inspection: If required, CDSCO may conduct an inspection of the manufacturing facility. Ensure that the facility complies with GMP and is prepared for the inspection.

8. Approval and Registration:

• Receive Certificate: After successful review and any necessary inspections, CDSCO will issue a registration certificate, allowing the device to be marketed in India.

Where to Handle the Application:

1. CDSCO SUGAM Portal:

   • Primary Platform: The CDSCO SUGAM portal is the main platform for submitting applications and handling the registration process. Access it here: SUGAM Portal.

2. CDSCO Headquarters:

   • Address:
     • Central Drugs Standard Control Organization (CDSCO)
     • FDA Bhawan, Kotla Road
     • New Delhi - 110 002, India
   • Phone: +91-11-2338 7400 / 2338 6571
   • Email: cdso@nic.in

Key Considerations:

• Compliance: Ensure all submissions comply with CDSCO guidelines and Indian regulations.
• Documentation: Double-check all documents for accuracy and completeness before submission.
• Consultation: Engage with regulatory consultants or experts to navigate the process efficiently if needed.