Applying for CDSCO registration of Class A medical devices involves several well-defined processes. Here’s a step-by-step breakdown:

1. Determine Device Classification:

• Verify Classification: Confirm that your device is correctly classified as Class A under the Medical Devices Rules, 2017. Class A devices are low-risk and generally include simple devices.

2. Prepare Required Documentation:

• Technical Documentation:
  • Device Description: Detailed description of the device and its intended use.
  • Design and Development: Information on design, materials, and manufacturing processes.
  • Performance Data: Evidence of safety and performance, including test results and clinical evaluations.
  • Labeling and Packaging: Samples and details of labeling, including instructions for use and packaging.
• Quality Management System: ISO 13485 certification or equivalent.
• Manufacturing License: Certificate or license from the regulatory authority of the device’s country of origin.

3. Register on the SUGAM Portal:

• Account Creation: Create an account on the CDSCO SUGAM portal, the online platform for submitting applications and managing registrations.
• Submit Application: Complete and submit the application form online. Ensure all sections are filled out accurately.

4. Attach Documents:

• Upload Files: Attach all necessary documentation to the application on the SUGAM portal. Ensure documents are clear and correctly formatted.

5. Pay Registration Fees:

• Fee Payment: Pay the applicable registration fee via the SUGAM portal. The fee varies based on the type and classification of the device.
• Payment Proof: Keep the payment receipt or confirmation as proof.

6. Application Review:

• Initial Check: CDSCO will perform an initial review to ensure that all required documents and information are submitted.
• Detailed Evaluation: The review process includes evaluating the technical documentation, compliance with standards, and risk assessment.

7. Respond to Queries:

• Additional Information: If CDSCO requests additional information or clarification, respond promptly with the required details to avoid delays.
• Documentation Updates: Update or correct any documentation as per CDSCO’s feedback.

8. Inspection (if Required):

• Facility Inspection: CDSCO may conduct an inspection of the manufacturing facility, especially for imported devices. Ensure the facility meets regulatory standards and is prepared for inspection.

9. Approval and Issuance:

• Registration Certificate: Upon successful review and completion of any required inspections, CDSCO will issue a registration certificate for the Class A medical device.
• Review Certificate: Verify the details on the certificate to ensure accuracy.

10. Post-Registration Requirements:

• Post-Market Surveillance: Implement a system for monitoring the device’s performance and report any adverse events or safety issues to CDSCO.
• Record Keeping: Maintain accurate records of the registration and all related documentation.
• Renewal and Amendments: Be aware of the renewal process and deadlines. Apply for amendments if there are changes to the device or its documentation.

Summary of Steps:

1. Determine Device Classification: Confirm that the device is Class A.
2. Prepare Documentation: Gather and prepare all required documents.
3. Register on SUGAM Portal: Create an account and submit the application.
4. Attach Documents: Upload all necessary documentation.
5. Pay Fees: Complete the fee payment process.
6. Application Review: CDSCO reviews the application and documents.
7. Respond to Queries: Address any requests for additional information.
8. Inspection (if needed): Prepare for and undergo facility inspection.
9. Approval and Issuance: Obtain and verify the registration certificate.
10. Post-Registration: Implement surveillance, maintain records, and manage renewals and amendments.

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