To obtain CDSCO registration for Class D medical devices in India, several key conditions must be met:

1. Regulatory Compliance:

• Adherence to Indian Regulations: Ensure compliance with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
• Device Classification: Confirm that the device is correctly classified as Class D, which is the highest risk category.

2. Clinical Evaluation:

• Clinical Data: Provide robust clinical evidence demonstrating the safety and efficacy of the device. This may include clinical trial results, literature reviews, or other relevant data.
• Ethics Committee Approval: If applicable, obtain approval from an ethics committee for any clinical trials conducted.

3. Quality Management System (QMS):

• ISO 13485 Certification: Ensure the manufacturing facility has ISO 13485 certification or equivalent, proving compliance with international quality management standards for medical devices.

4. Manufacturing Compliance:

• Good Manufacturing Practices (GMP): Provide evidence that the manufacturing facility complies with GMP requirements.
• Manufacturing Site Details: Submit detailed information about the manufacturing site, including processes and quality control measures.

5. Technical Documentation:

• Device Master File: Include comprehensive technical documentation detailing design, manufacturing processes, and risk management.
• Safety and Performance Data: Submit data supporting the safety and performance claims of the device.

6. Labeling and Instructions:

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

7. Application Submission:

• Complete Application: Submit a complete and accurate application through the CDSCO SUGAM portal, including all required forms and documents.
• Fee Payment: Pay the applicable registration fees through the portal.

8. Additional Documentation (if applicable):

• Import License: If the device is imported, an import license may be required.
• Ethics Committee Approval: For devices undergoing clinical trials, include ethics committee approvals if applicable.

9. Post-Market Surveillance:

• Compliance with Post-Market Requirements: Adhere to post-market surveillance requirements, including reporting adverse events and maintaining compliance with ongoing regulations.

Key Considerations:

• Documentation Accuracy: Ensure all documents and submissions are accurate and complete to avoid delays or rejections.
• Consultation: Consider consulting with regulatory experts to ensure all conditions and requirements are met.

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