CDSCO registration for Class B medical devices in India is a regulatory process that ensures devices meet safety, efficacy, and quality standards before they can be marketed. Class B devices are considered moderate-risk and require a detailed review of their documentation and manufacturing practices.

Application Process:

1. Document Preparation: Compile documents such as a product dossier, labeling, clinical evidence (if applicable), risk analysis, and manufacturing details.

2. Create Account: Register on the CDSCO SUGAM portal to create an account for online submission.

3. Submit Application: Complete the online application form on SUGAM, upload the required documents, and pay the applicable fee.

4. Review and Inspection: CDSCO will review the application and may request additional information or conduct a facility inspection.

5. Certification: After successful review and inspection, CDSCO will issue a registration certificate allowing you to market the device in India.

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