Standards for Periodic Updates of CDSCO Registration

1. Regulatory Compliance:

   • Medical Devices Rules, 2017: Adhere to the latest version of these rules and any amendments or updates issued by CDSCO.
   • International Standards: Ensure compliance with relevant international standards such as ISO 13485 for quality management systems.

2. Quality Management:

   • ISO 13485: Maintain compliance with this standard for quality management systems applicable to medical devices.
   • Good Manufacturing Practices (GMP): Ensure that manufacturing practices are in line with GMP requirements.

3. Documentation:

   • Accuracy and Completeness: Ensure that all updated documents, including technical files, labeling, and instructions for use, are accurate, complete, and up-to-date.

Process for Periodic Updates

1. Monitor Regulatory Changes:

   • Stay Informed: Regularly review updates from CDSCO and other relevant regulatory bodies for changes in regulations, guidelines, or standards.
   • Subscribe to Updates: Register for regulatory alerts or updates from CDSCO to receive timely information.

2. Assess and Prepare Updates:

   • Evaluate Changes: Determine if there are any changes to device design, manufacturing, intended use, or labeling that necessitate updates.
   • Revise Documentation: Update the technical dossier, including device descriptions, clinical data, risk management reports, and labeling.

3. Submit Update Applications:

   • Prepare Application: Draft and submit an application for updates to CDSCO. This may include a formal amendment or notification of changes.
   • Include Supporting Documents: Attach revised documents such as updated labels, risk management reports, and any new clinical data.

4. Review and Approval:

   • CDSCO Review: CDSCO will review the submitted updates. Be prepared to provide additional information or clarification if requested.
   • Approval Notification: Await official communication from CDSCO regarding the approval of the updates.

5. Implement and Monitor:

   • Implement Changes: Apply the approved changes to your device and related documentation.
   • Post-Market Monitoring: Continue to monitor the device’s performance and ensure compliance with updated requirements.

6. Record Keeping:

   • Maintain Records: Keep detailed records of all updates, including documentation submitted, approvals received, and any communications with CDSCO.

Summary

1. Standards:

   • Follow Medical Devices Rules, 2017.
   • Maintain ISO 13485 and GMP compliance.
   • Ensure documentation is accurate and complete.

2. Process:

   • Monitor regulatory changes and subscribe to updates.
   • Assess and prepare necessary updates to documentation.
   • Submit update applications with supporting documents to CDSCO.
   • Await review and approval, then implement changes.
   • Keep detailed records of all updates and interactions with CDSCO.

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