Registering and applying for CDSCO registration of Class D medical devices involves a series of steps to ensure compliance with Indian regulatory requirements. Here’s a detailed guide on how to register and apply:

1. Pre-Application Preparations:

Understand Regulatory Requirements:

• Regulatory Framework: Familiarize yourself with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
• Class D Classification: Confirm that your device is classified as Class D, the highest risk category under the Indian regulations.

Prepare Documentation:

• Device Master File: Include comprehensive details about the device, such as design specifications, intended use, and manufacturing processes.
• Clinical Data: Provide clinical trial results or studies demonstrating the device’s safety and efficacy.
• Risk Management: Submit a risk management report outlining potential risks and mitigation strategies.
• Quality Management System (QMS): Ensure ISO 13485 certification or an equivalent QMS standard is in place. Prepare documentation proving compliance.

2. Register on the SUGAM Portal:

Account Creation:

• Access the Portal: Visit the SUGAM Portal.
• Create an Account: Register by creating a user account if you do not already have one.

Complete the Application Form:

• Log In: Access the portal using your credentials.
• Fill Application Form: Complete the online application form with details about the device and the manufacturer.

3. Prepare and Submit Application Documents:

Required Documents:

• Device Master File: Detailed description, design, and manufacturing information.
• Clinical Evaluation Report: Clinical data and safety/effectiveness studies.
• Risk Management File: Documented risk assessments and mitigation strategies.
• QMS Certification: Proof of ISO 13485 or equivalent certification.
• Labeling and Instructions for Use (IFU): Device labels and user instructions.
• Fees Payment Receipt: Proof of payment for registration fees.

Upload and Submit:

• Upload Documents: Attach all required documents to the application on the SUGAM portal.
• Submit Application: Review and submit the application electronically.

4. Pay Fees:

Payment Process:

• Fee Structure: Verify the fee structure for Class D medical devices as per the CDSCO guidelines.
• Online Payment: Pay the applicable fees through the SUGAM portal.
• Attach Receipt: Ensure the payment receipt is attached to your application.

5. Application Review Process:

Initial Review:

• Document Verification: CDSCO will review the application to ensure that all required documents are submitted.

Detailed Review:

• Technical Evaluation: Detailed assessment of technical documentation, clinical data, and risk management reports.
• Clinical Review: Evaluation of clinical trials or studies related to the device’s safety and efficacy.
• Request for Additional Information: CDSCO may request further details or clarifications.

6. Inspection (if applicable):

Facility Inspection:

• On-Site Inspection: CDSCO may conduct an inspection of the manufacturing facility to verify compliance with regulatory standards.
• Additional Evidence: Provide any additional documentation or evidence requested during the inspection.

7. Approval and Issuance:

Receive Registration:

• Registration Certificate: Upon successful review and inspection (if applicable), CDSCO will issue a registration certificate.
• Validity: The certificate is typically valid for 5 years.

8. Post-Registration Requirements:

Post-Market Surveillance:

• Monitor Device Performance: Implement a post-market surveillance plan to track the device’s performance and report any adverse events.
• Report Adverse Events: Notify CDSCO of any issues or adverse events related to the device.

Renewal:

• Renewal Process: Begin the renewal process before the certificate expires. Update documentation and pay renewal fees.

9. Compliance and Maintenance:

Regulatory Updates:

• Stay Informed: Keep up-to-date with changes in regulations and guidelines.
• Adapt Practices: Modify your practices to comply with new or revised requirements.

Quality Management:

• Ongoing Compliance: Regularly review and maintain your QMS. Conduct internal audits and ensure continued compliance with regulatory standards.

Additional Considerations:

• Timeliness: Ensure timely submission of documents and responses to CDSCO queries.
• Consult Experts: Seek advice from regulatory consultants if needed to navigate complex requirements.

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