Process, Required Documents, and Considerations for CDSCO Registration of Class D Medical Devices

1. Process:

Step 1: Prepare Documentation

• Compile Documents: Gather all necessary documents and information required for the application. This includes technical, clinical, and manufacturing details.

Step 2: Register on SUGAM Portal

• Create Account: Register on the CDSCO SUGAM portal (https://sugam.cdsco.gov.in) to access the application system.

Step 3: Complete Application Forms

• Fill Forms: Complete the online application forms available on the SUGAM portal. Provide detailed information about the device, its intended use, and manufacturing processes.

Step 4: Upload Documents

• Submit Documentation: Upload all required documents including clinical data, device descriptions, and quality management system certifications.

Step 5: Pay Fees

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

Step 6: Application Review

• Document Review: CDSCO will review the submitted documents. This may include requests for additional information or clarification.

Step 7: Site Inspection (if applicable)

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

Step 8: Approval and Registration

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

2. Required Documents:

a. Device Information:

• Device Description: Detailed description, including the design, technology, and intended use.
• Clinical Evaluation Report: Clinical data demonstrating the safety and efficacy of the device.

b. Manufacturing Information:

• Manufacturing Site Details: Information about the manufacturing facility, including location, processes, and GMP compliance.
• Quality Management System Certificate: ISO 13485 or equivalent certification for manufacturing quality.

c. Labeling and Instructions for Use:

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

d. Technical Documentation:

• Device Master File: Comprehensive technical file including design specifications, manufacturing processes, and risk management.
• Safety and Performance Data: Data supporting the device’s safety and performance claims.

e. Additional Documentation (if applicable):

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

3. Considerations:

a. Regulatory Compliance:

• Ensure adherence to all relevant regulations under the Drugs and Cosmetics Act and Rules. Compliance with Indian standards is crucial for successful registration.

b. Documentation Accuracy:

• Ensure all submitted documents are complete and accurate to avoid delays in the application process.

c. Professional Assistance:

• Consider consulting with regulatory affairs experts or legal advisors to navigate complex requirements and ensure a smooth registration process.

d. Application Timeline:

• Be aware of the typical timeline for registration, which can range from 6 to 12 months, depending on various factors such as the complexity of the device and the completeness of the submission.

e. Post-Approval Obligations:

• Adhere to post-market surveillance requirements, including adverse event reporting and maintaining compliance with Indian regulations.

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