The process for CDSCO registration of Class D medical devices involves several key steps. Here's a detailed outline of the process:

1. Pre-Application Preparations:

• Understand Regulations: Familiarize yourself with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
• Classify the Device: Confirm that your device is classified as Class D, the highest risk classification, and review the specific requirements for this class.
• Prepare Documentation: Gather all required documentation, including technical files, clinical data, quality management system details, and risk management reports.

2. Register on the SUGAM Portal:

• Create an Account: Register on the SUGAM Portal, the online platform for submitting medical device registration applications to CDSCO.
• Complete Application: Fill out the online application form with device details, manufacturer information, and other required data.

3. Submit Technical Documentation:

• Device Master File: Upload detailed technical documentation, including device description, specifications, manufacturing processes, and performance data.
• Clinical Evaluation: Submit clinical data and evaluation reports demonstrating the device’s safety and effectiveness.
• Manufacturing Information: Provide details about the manufacturing process, quality control procedures, and compliance with ISO 13485.

4. Pay Fees:

• Fee Payment: Pay the applicable registration fees online through the SUGAM portal. Ensure that the payment receipt is attached to your application.

5. Review and Inspection:

• Application Review: CDSCO will review your application and may request additional information or clarifications.
• Inspection (if applicable): CDSCO may conduct an inspection of the manufacturing facility or request additional documentation to verify compliance with regulatory requirements.

6. Approval and Issuance:

• Receive Registration: Once the application is approved, CDSCO will issue a registration certificate for the Class D medical device.
• Certification Validity: The registration is generally valid for 5 years. Ensure timely renewal before the certificate expires.

7. Post-Registration Requirements:

• Post-Market Surveillance: Implement and maintain a post-market surveillance plan to monitor device performance and report any adverse events or safety issues to CDSCO.
• Compliance Updates: Notify CDSCO of any significant changes to the device or manufacturing processes and update your documentation as necessary.

Key Considerations:

• Timely Submissions: Submit all required documentation and fees in a timely manner to avoid delays.
• Consult Experts: Engage with regulatory consultants if needed to ensure compliance and address any issues that arise during the process.

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