For Class C medical device registration with the Central Drugs Standard Control Organization (CDSCO) in India, follow these detailed processes and consider the required documents:

Processes

1. Preparation

   • Classify Your Device: Ensure your device is classified as Class C based on CDSCO guidelines.
   • Gather Documentation: Compile all necessary documents, ensuring they meet CDSCO standards.

2. Online Application

   • Register on SUGAM: Create an account on the CDSCO SUGAM portal (SUGAM Portal).
   • Complete Application Form: Fill out the application form for Class C medical device registration.
   • Upload Documents: Submit required documents and attach them to the application.

3. Fees

   • Payment: Pay the registration fee online through the SUGAM portal.

4. Review Process

   • Initial Review: CDSCO will review the submitted application and documents.
   • Request for Additional Information: CDSCO may request further details or clarification.
   • Inspection: An on-site inspection of the manufacturing facility may be conducted.

5. Approval

   • Certification: Once the review and inspection are satisfactory, CDSCO will issue the registration certificate.

6. Post-Approval

   • Compliance: Adhere to CDSCO regulations for post-market surveillance and reporting.
   • Renewal: Monitor and apply for renewal of the registration as needed.

Required Documents

1. Application Form

   • Completed and submitted via the SUGAM portal.

2. Technical Documentation

   • Device Description: Detailed information on device specifications, intended use, and operation.
   • Technical File: Comprehensive details including design, materials, and manufacturing processes.

3. Clinical Evaluation Report

   • Clinical data or studies demonstrating the safety and efficacy of the device.

4. Risk Management File

   • Documentation of risk assessment and management strategies.

5. Quality Management System Certifications

   • ISO 13485: Certification for quality management systems specific to medical devices.
   • GMP Compliance: Proof of compliance with Good Manufacturing Practices.

6. Labeling and Packaging Information

   • Labels: Detailed labeling information including device name, usage instructions, and warnings.
   • Packaging: Information about packaging materials and methods.

7. Manufacturing License

   • Copy of the manufacturing license from the regulatory authority of the manufacturing country.

8. Import License (if applicable)

   • For imported devices, a valid import license issued by CDSCO.

Considerations

1. Documentation Accuracy

   • Ensure all documents are complete, accurate, and compliant with CDSCO requirements to avoid delays.

2. Regulatory Compliance

   • Stay updated with CDSCO guidelines and regulations, as they may change and impact the registration process.

3. Consultation

   • Consider consulting with a regulatory expert or consultant to navigate complex requirements and ensure a smooth registration process.

4. Timelines and Fees

   • Be aware of the registration fees and estimated processing times, which can vary based on the device and completeness of the application.

5. Post-Market Requirements

   • Prepare for post-market surveillance and reporting of any adverse events as part of ongoing compliance with CDSCO regulations.

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