To apply for CDSCO registration of Class B medical devices, you need to follow these steps:

1. SUGAM Portal

• Online Application: The primary platform for submitting applications is the CDSCO SUGAM portal. It is an online system where you can submit your application, upload required documents, and track the status of your application.
• Website: SUGAM Portal (access the SUGAM portal from the CDSCO website).

2. Prepare Documentation

• Gather Documents: Before you start the application process on SUGAM, ensure you have all necessary documents ready, including the technical dossier, labeling, clinical evidence, and manufacturing details.

3. Register and Create Account

• Create Account: Register on the SUGAM portal to create an account if you do not already have one. This will allow you to submit your application and manage it online.

4. Submit Application

• Fill Application Form: Complete the application form on the SUGAM portal with accurate information about the medical device.
• Upload Documents: Upload all required documentation and ensure that it complies with CDSCO requirements.
• Pay Fee: Pay the application fee online as specified on the portal.

5. Monitor and Respond

• Track Status: Monitor the status of your application through the SUGAM portal.
• Respond to Queries: Be prepared to respond to any requests for additional information or clarifications from CDSCO.

6. Contact CDSCO

• Regional Offices: If you need assistance or have specific queries, you can contact CDSCO regional offices. Contact information can be found on the CDSCO website.
• Support: Reach out to CDSCO support if you encounter technical issues with the SUGAM portal or need guidance.

Summary

• Platform: Apply through the CDSCO SUGAM portal.
• Website: SUGAM Portal.
• Documents: Prepare and upload all necessary documentation.
• Fees: Pay the application fee online.
• Contact: Use the CDSCO website for contact details and support.

If you need help with the specific steps on the SUGAM portal or have any other questions, let me know!