How to apply for CDSCO registration of Class A medical devices? Where to apply?
Release time:2024-08-27 11:14:10 The author: source:
Access the Portal: Visit the CDSCO online portal, known as SUGAM, at SUGAM Portal.

To apply for CDSCO registration of Class A medical devices, follow these steps:

Application Process:

  1. Register on the SUGAM Portal:

    • Access the Portal: Visit the CDSCO online portal, known as SUGAM, at SUGAM Portal.
    • Create an Account: Register by creating an account if you do not have one already.
  2. Complete the Application Form:

    • Fill Out the Form: Log in to the SUGAM portal and complete the online application form for Class A medical devices. Provide detailed information about the device, manufacturer, and other relevant details.
  3. Upload Required Documents:

    • Document Submission: Upload all required documents, including product descriptions, labeling information, quality management system certifications, and any additional supporting evidence.
  4. Submit the Application:

    • Review and Submit: Review all information and documents for accuracy. Submit the application through the SUGAM portal.
  5. Pay the Application Fee:

    • Fee Payment: Pay the required registration fee online through the portal. Ensure you retain proof of payment.
  6. Track Application Status:

    • Monitor Progress: Use the SUGAM portal to track the status of your application and respond to any requests for additional information from CDSCO.

Where to Apply:

  • CDSCO Online Portal (SUGAM): All submissions, including the application and document uploads, are handled through the SUGAM portal. This is the primary platform for applying and managing CDSCO registrations for medical devices.

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