To apply for CDSCO (Central Drugs Standard Control Organization) registration of Class B medical devices in India, follow these steps and use the specified platforms:

1. Prepare Your Documentation

Before applying, ensure you have prepared all required documents, including:

• Technical Documentation: Device description, specifications, clinical evidence, and risk analysis.
• Quality Management Documentation: GMP compliance evidence or ISO 13485 certification.
• Labeling and Packaging Information: Draft labels and packaging details.
• Regulatory Certificates: Foreign approvals (if applicable) and manufacturing license.
• Application Form and Fee: Complete the form and prepare for fee payment.

2. Create an Account on the SUGAM Portal

• Visit the SUGAM Portal: Go to the CDSCO SUGAM portal at SUGAM Portal.
• Register: If you do not have an account, register by creating a new user profile on the portal. You will need to provide basic information about your company and contact details.

3. Submit Your Application

• Login: Log in to the SUGAM portal using your registered account credentials.
• Complete the Application Form: Fill out the application form with accurate information about the Class B medical device. This includes details about the device, intended use, and manufacturing information.
• Upload Documents: Upload all required documents in the specified formats (usually PDF). Ensure that the files are clear and legible.
• Pay the Application Fee: Pay the application fee online through the payment gateway provided on the SUGAM portal. The fee amount depends on the type of device and other factors.

4. Track Your Application

• Monitor Status: After submission, you can track the status of your application on the SUGAM portal. Check for any updates or requests for additional information.
• Respond to Queries: If CDSCO requests additional information or clarification, respond promptly to avoid delays in the processing of your application.

5. Await Review and Approval

• Review Process: CDSCO will review your application and documentation. This may involve a detailed examination of your submitted materials.
• Inspection: If required, CDSCO may conduct an inspection of the manufacturing facility to verify compliance with GMP and other regulations.

6. Post-Approval Obligations

• Receive Registration Certificate: Upon successful review and, if applicable, inspection, CDSCO will issue a registration certificate for the Class B medical device.
• Compliance: Ensure ongoing compliance with CDSCO regulations, including post-market surveillance and reporting of any adverse events.

Where to Apply

• Primary Platform: The application for CDSCO registration is submitted through the SUGAM Portal. This is the official online platform for submitting applications and managing regulatory processes with CDSCO.

Summary

1. Prepare Documentation: Gather and prepare all required documents.
2. Create Account: Register on the SUGAM portal if you don’t already have an account.
3. Submit Application: Complete the application form, upload documents, and pay the fee on the SUGAM portal.
4. Track and Respond: Monitor the application status and respond to any queries from CDSCO.
5. Receive and Comply: Obtain the registration certificate and ensure ongoing compliance.

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