For CDSCO (Central Drugs Standard Control Organization) registration of Class B medical devices in India, follow this comprehensive guide on the process, required materials, and precautions:

Process for CDSCO Registration

1. Determine Device Classification:

   • Verify that your device is correctly classified as a Class B device, which includes moderate-risk devices.

2. Prepare Documentation:

   • Gather all required documents and ensure they meet CDSCO requirements.

3. Create Account on SUGAM Portal:

   • Register on the CDSCO SUGAM portal (https://cdsco.gov.in) to submit your application online.

4. Submit Application:

   • Complete the online application form, upload all required documents, and pay the application fee.

5. Review and Inspection:

   • CDSCO will review your application. If necessary, an inspection of the manufacturing facility may be conducted.

6. Approval:

   • Upon successful review and, if applicable, inspection, CDSCO will issue a registration certificate.

7. Post-Market Obligations:

   • Monitor the device post-market and report any adverse events.

Required Materials

1. Technical Documentation:

   • Device Description: Detailed information about the device’s intended use, design, and functionality.
   • Clinical Evidence: Clinical evaluation reports or studies demonstrating the safety and efficacy of the device.
   • Risk Analysis: Report assessing potential risks associated with the device and mitigation measures.

2. Quality Management Documentation:

   • GMP Compliance: Evidence of compliance with Good Manufacturing Practices (GMP) or ISO 13485.
   • Quality Assurance: Information on the quality management system in place at the manufacturing facility.

3. Labeling and Instructions:

   • Labeling: Information on the device’s labeling, including instructions for use, warnings, and packaging details.

4. Regulatory Certificates:

   • Foreign Certificates: Copies of any existing regulatory approvals, such as CE marking, if applicable.
   • Manufacturing License: A copy of the manufacturing license, if the device is manufactured in India.

5. Application Form and Fee:

   • Application Form: Complete the form available on the SUGAM portal.
   • Fee Payment: Pay the application fee online as specified by CDSCO.

Precautions

1. Accuracy of Information:

   • Ensure all information provided in the application is accurate and complete to avoid delays or rejections.

2. Document Quality:

   • Submit clear, legible, and properly formatted documents. Incomplete or unclear documentation can lead to requests for additional information or delays.

3. Compliance with Regulations:

   • Adhere to CDSCO guidelines and regulatory requirements. Ensure that your device and manufacturing practices comply with Indian regulations.

4. Prepare for Inspection:

   • Be ready for a potential inspection of the manufacturing facility. Ensure that all aspects of GMP are followed and documented.

5. Track Application Status:

   • Regularly monitor the status of your application through the SUGAM portal and respond promptly to any queries or additional information requests from CDSCO.

6. Legal and Consulting Advice:

   • Consider consulting with regulatory experts or legal advisors to navigate the registration process efficiently and ensure compliance with all requirements.

Summary

• Process: Register on the SUGAM portal, submit the application, and undergo review and inspection if required.
• Materials: Include technical documentation, quality management evidence, labeling, regulatory certificates, and application fee.
• Precautions: Ensure accuracy, compliance, and preparedness for inspection. Monitor your application and seek expert advice if needed.

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