The process for Class C medical device registration with the Central Drugs Standard Control Organization (CDSCO) in India involves several detailed steps. Here's a comprehensive guide to the process:

1. Pre-Application Preparation

• Understand Classification: Ensure your device is classified as Class C by referring to the CDSCO's classification criteria, which generally include higher-risk devices such as implants or devices used in critical care settings.
• Prepare Documentation: Collect all necessary documentation including:
  • Technical File: Detailed technical documentation of the device.
  • Clinical Evaluation Report: Evidence of clinical trials or studies supporting the safety and efficacy of the device.
  • Risk Management File: Risk assessment and management documentation.
  • Manufacturing and Quality Certifications: ISO 13485 (for quality management) and other relevant certifications.
  • Labeling and Packaging Information: Information on the device's labels, instructions for use, and packaging.

2. Create an Account on the SUGAM Portal

• Register on SUGAM: Visit the CDSCO SUGAM portal and create an account if you haven’t already. SUGAM is the online system used for the submission and tracking of applications.

3. Prepare and Submit Application

• Fill Out the Application Form: Complete the online application form on the SUGAM portal, providing detailed information about the medical device.
• Upload Documents: Attach all required documents in the specified formats as per the portal's requirements.
• Pay the Fees: The application will require payment of a registration fee. This can be done online through the portal.

4. Submission Review

• Initial Review: CDSCO will perform an initial review of the submitted application and documents.
• Additional Information: You may be asked to provide additional information or clarification during this stage.

5. Inspection and Testing

• Site Inspection: CDSCO may conduct an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
• Testing: In some cases, additional testing or evaluation of the device may be required.

6. Approval Process

• Review by Expert Committees: Your application and supporting documents will be reviewed by expert committees within CDSCO.
• Decision: Based on the review, CDSCO will either approve or reject the application. If approved, a registration certificate will be issued.

7. Post-Approval Requirements

• Compliance: Ensure ongoing compliance with CDSCO regulations, including post-market surveillance and reporting of adverse events.
• Renewal: Monitor the expiry of your registration certificate and apply for renewal as required.

Key Points to Remember

• Regulatory Updates: Stay informed about any changes in regulations or procedures by regularly checking CDSCO's announcements.
• Documentation: Ensure all documentation is complete and accurately reflects the device's specifications and intended use.
• Consultation: Consider consulting with regulatory experts or agencies for guidance on complex aspects of the application process.

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