For CDSCO registration of Class B medical devices in India, the technical document requirements are essential for demonstrating the safety, efficacy, and quality of the device. Here’s a detailed list of the required technical documents:

1. Device Description

• Detailed Device Information: A comprehensive description of the device, including its design, intended use, and functionality.
• Device Specifications: Technical specifications that detail the performance characteristics and operational parameters of the device.

2. Clinical Evidence

• Clinical Evaluation Report: Reports or studies that demonstrate the safety and efficacy of the device based on clinical trials or studies. This may include:
  • Clinical Study Reports: Results from clinical trials or studies conducted to validate the device’s performance and safety.
  • Literature Review: Reviews of existing literature and studies related to the device and its intended use.

3. Risk Management

• Risk Analysis Report: A comprehensive risk management report assessing potential risks associated with the device and detailing the strategies for risk mitigation. This includes:
  • Risk Identification: Identification of potential hazards and risks.
  • Risk Assessment: Evaluation of the severity and likelihood of identified risks.
  • Risk Control Measures: Measures implemented to control and mitigate identified risks.

4. Manufacturing and Quality Management

• Manufacturing Process Documentation: Detailed information about the manufacturing process, including:
  • Process Flow: Description of the manufacturing steps and procedures.
  • Quality Control Measures: Procedures and controls implemented to ensure product quality and consistency.
• Quality Management System (QMS) Documentation: Proof of adherence to quality management standards such as GMP or ISO 13485, including:
  • GMP Compliance Certificate: Certificate demonstrating compliance with Good Manufacturing Practices.
  • ISO 13485 Certificate: If applicable, provide a certificate for compliance with ISO 13485 standards.

5. Labeling and Packaging

• Labeling Information: Draft labels that include:
  • Device Name: The name of the device and its model number.
  • Intended Use: Description of the intended use and indications.
  • Instructions for Use: Detailed instructions on how to use the device safely and effectively.
  • Warnings and Precautions: Any warnings or precautions necessary for the safe use of the device.
• Packaging Details: Information about the packaging design and materials used for the device, including:
  • Packaging Specifications: Description of the packaging and how it protects the device.
  • Labeling on Packaging: Details on labeling requirements for packaging.

6. Performance Testing

• Performance Data: Results from performance testing demonstrating that the device meets its specifications and performs as intended. This may include:
  • Bench Testing: Results from laboratory or bench testing.
  • Pre-Clinical Testing: Data from animal studies or other pre-clinical tests.

7. Regulatory Compliance

• Foreign Regulatory Approvals: If the device has been approved or certified by other regulatory bodies (e.g., CE marking), provide copies of these approvals.
• Manufacturing License: A copy of the manufacturing license if the device is produced in India.

8. Technical File or Dossier

• Technical File: Compile all the above documents into a technical file or dossier. This file should be well-organized and clearly labeled to facilitate CDSCO’s review process.

Summary

1. Device Description: Detailed information and specifications.
2. Clinical Evidence: Clinical evaluation reports and studies.
3. Risk Management: Risk analysis and mitigation strategies.
4. Manufacturing and Quality Management: Manufacturing process and quality management documentation.
5. Labeling and Packaging: Draft labels and packaging details.
6. Performance Testing: Results from performance and pre-clinical testing.
7. Regulatory Compliance: Foreign approvals and manufacturing license.
8. Technical File: A well-organized technical dossier containing all documents.

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