For CDSCO registration of Class D medical devices, periodic updates and maintenance are essential to ensure ongoing compliance and device safety. Here’s an overview of the standards and processes for periodic updates:

1. Periodic Review and Renewal:

• Registration Renewal: Registration for Class D medical devices is typically valid for 5 years. Start the renewal process at least 6 months before the expiration date. Ensure that all necessary documents and fees are submitted for renewal.
• Update Application: Submit updated information as part of the renewal process if there have been changes in the device or manufacturing processes.

2. Compliance with Regulatory Changes:

• Monitor Regulatory Updates: Stay informed about changes in CDSCO regulations and guidelines that may affect your device. Update your practices and documentation to comply with new or revised requirements.
• Adapt to New Standards: Ensure that the device continues to meet current national and international standards and regulations.

3. Post-Market Surveillance Reports:

• Regular Reporting: Conduct regular post-market surveillance and submit reports to CDSCO if required. Include any adverse events, device performance issues, or recalls.
• Safety Updates: Report any new safety information or significant changes in risk profiles to CDSCO promptly.

4. Device Changes and Updates:

• Modification Notifications: Notify CDSCO of any significant changes to the device, such as design modifications, changes in manufacturing processes, or updates to labeling.
• Submit Documentation: Provide updated documentation reflecting the changes, including revised technical files, risk management reports, and clinical data if applicable.

5. Quality Management System (QMS) Maintenance:

• Ongoing Certification: Maintain ISO 13485 certification and ensure your QMS is up-to-date with current standards. Prepare for regular audits and inspections.
• Internal Audits: Conduct regular internal audits to ensure continued compliance with quality management requirements.

6. Periodic Testing and Evaluation:

• Performance Testing: Periodically test the device to ensure it continues to meet performance specifications and safety standards.
• Clinical Re-evaluation: If applicable, update clinical evaluations based on new data or changes in device use.

7. Labeling and Instructions for Use (IFU):

• Review and Update: Regularly review and update labeling and IFU to ensure accuracy and compliance with current regulations and standards.

8. Regulatory Communication:

• Maintain Communication: Keep open communication with CDSCO for any required

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