The process for CDSCO (Central Drugs Standard Control Organization) registration of Class B medical devices in India involves several key steps. Here’s a detailed breakdown of the procedure:

1. Determine Device Classification

• Identify Classification: Ensure your device is correctly classified as Class B. This classification includes devices that pose a moderate risk to the patient but are not as high-risk as Class C or D devices.

2. Prepare Documentation

• Technical Documentation: Prepare a comprehensive dossier including device description, intended use, labeling, and manufacturing details.
• Quality Management System: Ensure your manufacturing facility complies with Good Manufacturing Practices (GMP) or ISO 13485.
• Clinical Evidence: Include clinical evaluation reports or studies demonstrating the device’s safety and efficacy.
• Risk Analysis: Provide a risk management report assessing potential risks associated with the device.
• Labels and Instructions: Include labeling, instructions for use, and packaging details.
• Certificates: Provide any necessary certificates such as CE marking (if applicable).

3. Create an Account on SUGAM Portal

• Register: Visit the CDSCO SUGAM portal (https://cdsco.gov.in) and register for an account if you don't have one.
• Login: Use your credentials to log in to the portal.

4. Submit Online Application

• Application Form: Fill out the online application form available on the SUGAM portal.
• Upload Documents: Upload all required documents and technical data.
• Fee Payment: Pay the application fee as specified. The fee structure may vary based on the device and its classification.

5. Application Review

• Initial Screening: CDSCO will perform an initial review of the application for completeness.
• Technical Evaluation: A detailed technical evaluation will be conducted, including a review of submitted documents and clinical data.
• Additional Information: You may be requested to provide additional information or clarification.

6. Inspection (if required)

• Facility Inspection: CDSCO may conduct an inspection of the manufacturing facility to ensure compliance with GMP and other regulatory requirements.
• Audit Report: Prepare for the audit by ensuring all quality systems and processes are in place.

7. Approval and Certification

• Issuance of Certificate: Upon successful review and, if applicable, inspection, CDSCO will issue a registration certificate allowing you to market the device in India.
• Regulatory Compliance: Ensure ongoing compliance with CDSCO regulations, including post-market surveillance and reporting.

8. Post-Market Obligations

• Adverse Event Reporting: Monitor and report any adverse events or device-related issues to CDSCO.
• Renewals and Updates: Keep your registration updated with any changes in the device, manufacturing process, or labeling.

Key Points to Remember:

• Compliance: Ensure adherence to CDSCO guidelines and standards throughout the process.
• Timelines: The registration process may take several months, so plan accordingly.
• Consultation: Consider consulting with a regulatory expert or consultant for assistance with complex applications or to expedite the process.