To apply for CDSCO registration for Class B medical devices in India, follow these steps:
Prepare Documentation: Gather all necessary documents including product details, labeling, intended use, manufacturing process, and safety data.
Online Registration: Register on the CDSCO's online portal (SUGAM) and create an account.
Submit Application: Fill out the application form on the SUGAM portal, upload required documents, and pay the application fee.
Technical Review: CDSCO will review the application and may request additional information or clarifications.
Inspection: If required, CDSCO may conduct an inspection of the manufacturing facility.
Approval: Upon successful review and inspection, CDSCO will issue a registration certificate.
Compliance: Ensure ongoing compliance with CDSCO regulations and guidelines.
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