How to apply for CDSCO registration for Class B medical devices in India?
Release time:2024-08-28 16:20:21 The author: source:
Prepare Documentation: Gather all necessary documents including product details, labeling, intended use, manufacturing process, and safety data.

To apply for CDSCO registration for Class B medical devices in India, follow these steps:

  1. Prepare Documentation: Gather all necessary documents including product details, labeling, intended use, manufacturing process, and safety data.

  2. Online Registration: Register on the CDSCO's online portal (SUGAM) and create an account.

  3. Submit Application: Fill out the application form on the SUGAM portal, upload required documents, and pay the application fee.

  4. Technical Review: CDSCO will review the application and may request additional information or clarifications.

  5. Inspection: If required, CDSCO may conduct an inspection of the manufacturing facility.

  6. Approval: Upon successful review and inspection, CDSCO will issue a registration certificate.

  7. Compliance: Ensure ongoing compliance with CDSCO regulations and guidelines.

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