Documents Needed for CDSCO Registration of Class D Medical Devices

1. Device Information:

   • Device Description: Detailed description including intended use, design, and technology.
   • Clinical Evaluation Report: Comprehensive clinical data showing safety and efficacy. This includes clinical trial results or literature reviews.

2. Manufacturing Information:

   • Manufacturing Site Details: Information on the location, facilities, and manufacturing processes.
   • Good Manufacturing Practices (GMP) Compliance: Proof of adherence to GMP, typically through an ISO 13485 or similar certification.

3. Quality Management System (QMS) Certification:

   • ISO 13485 Certification: Certification demonstrating that the manufacturing processes meet international quality management standards.

4. Labeling and Instructions for Use:

   • Product Labels: Labels including product name, manufacturer details, and usage instructions.
   • Instructions for Use (IFU): Detailed usage instructions to ensure safe and effective use of the device.

5. Technical Documentation:

   • Device Master File: Technical file including design specifications, manufacturing details, and risk management reports.
   • Safety and Performance Data: Data supporting the claims of safety and performance of the device.

6. Additional Documentation (if applicable):

   • Import License: If the device is imported, an import license may be required.
   • Ethics Committee Approval: For devices undergoing clinical trials, ethics committee approval may be necessary.

How to Prepare the Application:

1. Gather Documentation:

   • Collect all required documents and ensure they are complete and accurate. Verify that clinical evaluation reports, QMS certifications, and technical documentation are up-to-date.

2. Register on SUGAM Portal:

   • Create Account: Register on the CDSCO SUGAM portal (https://sugam.cdsco.gov.in). This is the platform for submitting applications.

3. Complete Application Forms:

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

4. Upload Documents:

   • Submit Files: Upload all required documents, including device descriptions, clinical data, QMS certificates, and labeling information. Ensure all documents are in the correct format and size as specified by the portal.

5. Pay Fees:

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

6. Review and Finalize:

   • Review Submission: Double-check all submitted information for accuracy and completeness. Correct any errors before final submission.

7. Track Application:

   • Monitor Status: Use the SUGAM portal to track the status of your application and respond to any requests for additional information from CDSCO.

8. Prepare for Inspection (if applicable):

   • Site Inspection: If an inspection of the manufacturing facility is required, ensure that the facility is prepared and that all documentation and procedures comply with CDSCO requirements.

Key Considerations:

• Compliance: Adhere to CDSCO guidelines and Indian regulations to ensure a smooth registration process.
• Consultation: Seek advice from regulatory experts if needed to navigate the application process effectively.
• Documentation Accuracy: Ensure all documents are accurate and complete to avoid delays.