For CDSCO registration of Class D medical devices in India, the following conditions must be met:

1. Regulatory Compliance:

   • Adherence to Regulations: Ensure compliance with the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017.
   • Device Classification: Verify that the device is accurately classified as Class D, the highest risk category, based on its intended use and potential risks.

2. Clinical Evaluation:

   • Clinical Data: Provide comprehensive clinical evidence demonstrating the device’s safety and efficacy. This includes clinical trial results, peer-reviewed literature, or equivalent data.
   • Ethics Committee Approval: For clinical trials, obtain and submit approval from an ethics committee.

3. Quality Management System (QMS):

   • Certification: Submit proof of ISO 13485 certification or equivalent for the manufacturing facility, indicating adherence to international quality management standards.

4. Manufacturing Compliance:

   • Good Manufacturing Practices (GMP): Demonstrate that the manufacturing facility adheres to GMP requirements.
   • Manufacturing Site Details: Provide detailed information about the manufacturing site, including processes, quality control measures, and facility conditions.

5. Technical Documentation:

   • Device Master File: Include detailed technical documentation such as design specifications, manufacturing processes, and risk management reports.
   • Safety and Performance Data: Submit data supporting the device’s safety and performance claims.

6. Labeling and Instructions:

   • Product Labels: Ensure labels include the product name, manufacturer details, and usage instructions.
   • Instructions for Use (IFU): Provide clear and comprehensive instructions for the safe and effective use of the device.

7. Application Submission:

   • Complete Application: Submit a complete application through the CDSCO SUGAM portal, including all required forms and documentation.
   • Fee Payment: Pay the required registration fees as per CDSCO guidelines.

8. Additional Documentation (if applicable):

   • Import License: If the device is imported, include an import license.
   • Ethics Committee Approval: For devices undergoing clinical trials, provide relevant ethics committee approvals.

9. Post-Market Surveillance:

   • Adherence to Requirements: Comply with post-market surveillance obligations, including reporting adverse events and maintaining regulatory compliance.

Considerations:

• Accuracy: Ensure all submissions are accurate and complete to avoid delays or rejections.
• Consultation: Engage regulatory experts to navigate the application process effectively.