Requirements for CDSCO Registration of Class D Medical Devices in India

1. Product Information:

   • Device Description: Detailed information about the device, including its intended use, design, and technology.
   • Clinical Evaluation: Clinical data demonstrating the safety, effectiveness, and performance of the device. This includes clinical trial reports or clinical evaluation reports.

2. Manufacturing Information:

   • Manufacturing Site Details: Information about the manufacturing facility, including location, production processes, and quality control measures.
   • Good Manufacturing Practices (GMP): Evidence of compliance with GMP, typically through an ISO 13485 certification or similar quality management system certification.

3. Quality Management System (QMS) Certification:

   • ISO 13485 Certification: Certification demonstrating that the manufacturer adheres to international quality management standards for medical devices.

4. Labeling and Instructions for Use:

   • Product Labels: Labels that include the product name, manufacturer details, and usage instructions, compliant with Indian regulations.
   • Instructions for Use (IFU): Detailed instructions on how to use the device safely and effectively.

5. Technical Documentation:

   • Device Master File: Comprehensive documentation that includes design specifications, manufacturing processes, and risk management reports.
   • Safety and Performance Data: Data supporting the safety and performance claims of the device.

6. Regulatory Forms:

   • Application Forms: Completed forms available on the CDSCO SUGAM portal, including device and manufacturer details.

7. Fees:

   • Payment: Fees for registration, which vary based on the device category and classification. Payment is made through the SUGAM portal.

8. Additional Documentation (if applicable):

   • Import License: If the device is imported, an import license may be required.
   • Ethics Committee Approval: For clinical trials, approval from an ethics committee may be needed.

Additional Considerations:

• Adherence to Regulations: Ensure compliance with all relevant regulations under the Drugs and Cosmetics Act and Rules.
• Professional Assistance: Consulting with regulatory affairs experts can help navigate complex requirements and ensure complete and accurate submissions.

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