For Class C medical device registration with the Central Drugs Standard Control Organization (CDSCO) in India, the technical document requirements are extensive and crucial to ensure that the device meets regulatory standards for safety, efficacy, and quality. Here's a detailed list of the technical documentation required:

1. Device Description

• Detailed Description: A comprehensive description of the medical device, including its intended use, design, components, and functionalities.
• Device Classification: Justification for the classification of the device as Class C.

2. Technical File

• Design and Manufacturing Information: Detailed information about the design, manufacturing processes, and materials used. This should include:

  • Design drawings and specifications
  • Manufacturing process flowcharts
  • Material specifications
  • Assembly and testing procedures

• Performance Characteristics: Data demonstrating the device’s performance characteristics, including efficacy and safety.

3. Clinical Evaluation Report

• Clinical Data: Evidence from clinical studies or trials that demonstrate the safety and effectiveness of the device. This may include:

  • Clinical trial reports
  • Study protocols
  • Summary of clinical evidence

• Literature Review: Relevant literature supporting the clinical evaluation, including any published studies or research related to the device.

4. Risk Management Documentation

• Risk Assessment: Detailed risk analysis identifying potential risks associated with the device and the strategies to mitigate these risks.
• Risk Management Plan: A comprehensive plan that outlines risk management activities throughout the device lifecycle.

5. Quality Management System (QMS) Documentation

• ISO 13485 Certification: Evidence of ISO 13485 certification for the manufacturer’s quality management system. This includes:

  • Quality manual
  • Procedures and work instructions
  • Records of audits and corrective actions

• Good Manufacturing Practices (GMP) Compliance: Documentation showing compliance with GMP standards.

6. Labeling and Packaging Information

• Labels: Detailed labeling information, including:

  • Device name
  • Intended use
  • Instructions for use
  • Warnings and precautions
  • Manufacturer’s information

• Packaging: Information on the packaging materials and methods, including:

  • Packaging design
  • Sterilization methods (if applicable)
  • Storage conditions

7. Manufacturing License

• Copy of Manufacturing License: A copy of the manufacturing license issued by the regulatory authority in the country where the device is produced.

8. Import License (if applicable)

• Import License: For devices imported into India, a copy of the import license issued by CDSCO.

9. Authorization Letter (if applicable)

• Authorization Letter: A letter from the foreign manufacturer authorizing the Indian applicant to act on their behalf, if the device is manufactured outside India.

10. Product Literature

• Brochures and Technical Data Sheets: Product literature that includes comprehensive details about the device, such as:
  • Product specifications
  • Features and benefits
  • Clinical indications

11. Environmental Impact Assessment (if applicable)

• Environmental Impact: Assessment of any potential environmental impact of the device and the steps taken to mitigate any negative effects.

12. Post-Market Surveillance Plan

• Surveillance Plan: A plan for monitoring the device’s performance post-market, including procedures for reporting adverse events and device failures.

13. Additional Technical Documentation

• Software Documentation: If the device includes software, provide detailed software documentation including development, validation, and maintenance records.
• Biocompatibility Data: For devices in contact with the body, evidence of biocompatibility testing.

Preparation Tips

• Organize Documents: Ensure all technical documents are well-organized and clearly labeled.
• Consult Guidelines: Refer to CDSCO’s guidelines for any specific requirements related to your device.
• Consult Experts: Consider working with regulatory experts or consultants to ensure compliance with all technical requirements.

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