For CDSCO registration of Class D medical devices in India, the technical document requirements are comprehensive and ensure the device’s safety, efficacy, and quality. Here is a detailed list of the technical documentation typically required:

1. Device Master File:

• Device Description: Detailed description of the medical device, including its intended use, design, and technology.
• Specifications: Technical specifications of the device, including physical, chemical, and biological properties.

2. Clinical Evaluation:

• Clinical Data: Evidence demonstrating the safety and effectiveness of the device. This may include clinical trial results, published literature, or clinical studies.
• Clinical Evaluation Report: A comprehensive report summarizing the clinical data and how it supports the device's safety and efficacy.

3. Manufacturing Information:

• Manufacturing Process: Detailed description of the manufacturing processes, including raw materials, production techniques, and quality control measures.
• Quality Control Procedures: Information on quality control procedures and testing protocols to ensure device safety and performance.

4. Quality Management System (QMS) Documentation:

• ISO 13485 Certification: Proof of certification indicating compliance with international quality management standards for medical devices.
• QMS Manual: A manual outlining the quality management system in place, including procedures for design control, production, and post-market surveillance.

5. Risk Management:

• Risk Analysis Report: A report identifying potential risks associated with the device, including how these risks are mitigated.
• Risk Management Plan: A plan outlining the strategies for managing and minimizing risks throughout the device’s lifecycle.

6. Labeling and Instructions for Use (IFU):

• Product Labels: Labels on the device packaging that include the product name, manufacturer details, and usage instructions.
• Instructions for Use: Detailed instructions for the safe and effective use of the device, including any warnings, precautions, and contraindications.

7. Safety and Performance Data:

• Pre-Clinical Data: Data from pre-clinical studies or tests demonstrating the device’s safety and performance before clinical trials.
• Performance Testing: Results from performance testing that validate the device’s claims and intended use.

8. Technical Files:

• Design Dossiers: Documents detailing the design, development, and validation processes for the device.
• Compliance with Standards: Documentation showing compliance with relevant international and national standards, such as IEC or ISO standards.

9. Additional Documentation (if applicable):

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

Preparation Tips:

• Organize Documentation: Ensure that all documents are well-organized, clearly labeled, and formatted according to CDSCO guidelines.
• Consult Experts: Engage with regulatory consultants or experts to ensure that all technical documentation meets the required standards and regulations.

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