Handling CDSCO registration for Class A medical devices involves a systematic approach to ensure compliance with regulatory requirements and streamline the application process. Here’s a step-by-step guide:

1. Understand Regulatory Requirements:

• Regulations Review: Familiarize yourself with the Medical Devices Rules, 2017, and any relevant CDSCO guidelines. Understand the classification of your device and the specific requirements for Class A medical devices.

2. Prepare Documentation:

• Technical File: Assemble a comprehensive technical file that includes:
  • Device description and intended use
  • Design and manufacturing information
  • Performance and safety data
  • Labeling and packaging details
• Quality Management System: Ensure you have ISO 13485 certification or an equivalent quality management system in place. Prepare documentation demonstrating adherence to these standards.
• Manufacturing License: Obtain and prepare a copy of the manufacturing license or certificate from the regulatory authority in the device’s country of origin.

3. Register on SUGAM Portal:

• Create an Account: Register on the CDSCO SUGAM portal, the official platform for managing applications and registrations.
• Complete Application: Fill out the application form on the SUGAM portal with accurate and complete information. Attach all required documents.

4. Submit the Application:

• Attach Documents: Upload the prepared documentation along with the application form on the SUGAM portal.
• Pay Fees: Pay the applicable registration fee through the portal. Keep proof of payment for your records.

5. Monitor Application Status:

• Track Progress: Regularly check the status of your application on the SUGAM portal.
• Respond to Queries: Be prepared to respond promptly to any requests from CDSCO for additional information or clarification.

6. Prepare for Inspection (if required):

• Facility Readiness: Ensure that your manufacturing facility is compliant with Good Manufacturing Practices (GMP) and is prepared for any potential inspections by CDSCO.
• Documentation Availability: Have all necessary documentation and records available for review during the inspection.

7. Review and Approval:

• Document Review: CDSCO will review the submitted documents and may request additional information if needed. Ensure that all responses are timely and thorough.
• Approval Notification: Once the review is complete and any inspections are conducted, CDSCO will issue the registration certificate. Review the certificate to confirm its accuracy.

8. Post-Registration Compliance:

• Post-Market Surveillance: Implement a system for monitoring the device’s performance in the market. Report any adverse events or issues to CDSCO as required.
• Maintain Records: Keep detailed records of the registration, including the certificate and any correspondence with CDSCO.
• Renewal and Amendments: Be aware of renewal deadlines and apply for amendments if there are significant changes to the device or its documentation.

9. Stay Updated:

• Regulatory Changes: Regularly check for updates or changes in regulations from CDSCO to ensure ongoing compliance.
• Training and Updates: Stay informed about any new requirements or standards that may affect your device.

Key Considerations:

• Accuracy: Ensure all submitted information and documentation are accurate and complete to avoid delays.
• Timeliness: Adhere to submission deadlines and respond promptly to any requests from CDSCO.
• Documentation: Keep all documentation organized and readily accessible for review and audits.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn