Technical File Checklist for Medical Devices: Documents Required for CDSCO and Overseas Submissions

Are you a medical device manufacturer, importer, or startup looking to introduce your innovative products to the Indian or global market? Do you find the regulatory landscape, especially the documentation requirements, daunting? If so, you’re not alone. Navigating the complex world of medical device regulations requires meticulous preparation with the device while applying for a Medical Device Import License (MD-14 / MD-15) in India.

The Complete Medical Device Technical File Checklist for CDSCO and International Submissions (2026 Guide) 

Every medical device, from a simple Band-Aid to a complex MRI machine, requires a robust set of technical documents to demonstrate its safety, quality, and performance. This collection of documents is known as the Technical File, or Design Dossier, in some regions. It’s not just a formality; it’s a comprehensive dossier that tells your device’s entire story, from conception and design to manufacturing, clinical use, and post-market surveillance. 

For entities seeking market authorization in India, compliance with the Medical Device Rules, 2017, overseen by the Central Drugs Standard Control Organisation (CDSCO), is paramount. Similarly, international markets like the EU (MDR) and the USA (FDA) have their own stringent requirements, often sharing common principles but differing in specifics. This guide will walk you through the essential components of a medical device technical file checklist, covering both CDSCO and broader international considerations. 

Why a Robust Technical File is Your Gateway to Market Success 

A comprehensive technical file is not just a regulatory requirement but a strategic asset for medical device manufacturers and importers. It provides several advantages:

• Ensures Regulatory Compliance – Demonstrates that the device meets required safety and performance standards, reducing approval delays and rejections.

• Supports Risk Mitigation – Proper documentation helps identify and control risks early, protecting patients and reducing liability and recall risks.

• Enables Faster Global Market Access – A well-structured technical file can be adapted for multiple markets, simplifying international submissions and accelerating expansion.

Essential Components: What Goes into Your Medical Device Technical File? 

A technical file is a living document, evolving with your device’s lifecycle. It generally encompasses administrative details, a complete device description, design and manufacturing information, risk management, clinical evaluation, performance data, and post-market surveillance plans.

Key Documents for CDSCO Submissions 

For medical devices being imported or manufactured in India, the CDSCO requires specific documents to be included in the technical file. These requirements are largely dictated by the device’s risk classification (Class A, B, C, or D), with higher-risk devices demanding more extensive documentation. 

Administrative Documents: 

1. Application Forms

• For Import:
  • Form MD-14: Application for import license
  • Form MD-15: Grant of import license
• For Manufacturing:
  • Class A and Class B Devices:
    • Form MD-3: Application for manufacturing license
    • Form MD-5: Grant of manufacturing license
  • Class C and Class D Devices:
    • Form MD-7: Application for manufacturing license
    • Form MD-9: Grant of manufacturing license

2. Plant Master File (PMF)

Detailed information about the manufacturing site, including:

• Facility layout
• Quality Management System (QMS)
• Organizational structure and personnel details
• Manufacturing processes and controls

3. Device Master File (DMF)

Comprehensive technical documentation of the medical device, including:

• Device description and specifications
• Design and development details
• Manufacturing processes
• Quality control procedures
• Safety and performance data

4. Authorised Indian Representative (AIR) Details

Mandatory for foreign manufacturers:

• AIR must hold valid distribution/wholesale license as per State Licensing Authority
• Acts as the official liaison with CDSCO
• Responsible for:
  • Regulatory communication
  • Post-market surveillance
  • Vigilance reporting
  • Compliance management

5. Quality Management System (QMS) Certificate

• Valid ISO 13485 certificate
• Demonstrates compliance with international medical device quality standards
• Confirms implementation of a robust quality management system

Device Description and Specifications

1 Intended Use and Indications

• Clear description of the device purpose
• Medical conditions or parameters the device is intended to diagnose, monitor, prevent, or treat
• Target patient population and intended users

2 Device Classification

• Classification based on CDSCO risk-based framework (Class A, B, C, D)
• Example: Blood Pressure Monitor is generally classified as Class B

3 Principle of Operation

• Explanation of how the device functions
• Scientific and technical principles involved
• Operating mechanism and working logic

4 Physical and Performance Specifications

• Technical specifications such as:
  • Dimensions
  • Weight
  • Materials used
  • Accuracy levels
  • Operating conditions
  • Electrical specifications (if applicable)

5 Previous Generations / Similar Devices

• Comparison with:
  • Earlier versions of the same device
  • Predicate or equivalent devices
• Highlight improvements, modifications, or differences

Design and Manufacturing Information

1 Design Drawings and Blueprints

• Complete technical drawings
• Engineering schematics
• Product architecture diagrams

2 Bill of Materials (BOM)

• List of all components and raw materials used
• Component specifications
• Supplier details (if required)

3 Manufacturing Process Flow

• Step-by-step manufacturing process
• Assembly procedures
• Quality control checkpoints
• Process validation details

4 Sterilisation Validation (If Applicable)

• Sterilisation method used (e.g., EO, Gamma, Steam)
• Validation reports demonstrating effectiveness
• Sterility assurance level (SAL) documentation

Risk Management Documentation

Risk Management File (As per ISO 14971)

Includes:

• Risk identification
• Risk analysis
• Risk evaluation
• Risk control measures
• Residual risk assessment
• Risk management plan and report

Clinical Evaluation Evidence

1 Clinical Evaluation Report (CER)

• Systematic assessment of clinical data
• Demonstrates safety and performance
• Includes literature review, clinical investigations, or equivalent data

2 Post-Market Surveillance (PMS) Plan

• System to monitor device performance after market release
• Complaint handling procedures
• Adverse event monitoring

3 Post-Market Clinical Follow-up (PMCF) Plan

• Required for higher-risk devices (Class C and D)
• Ongoing clinical monitoring
• Collection of additional safety and performance data

Performance and Safety Data

1 Biocompatibility Testing Reports

• Required for devices in contact with human body
• Compliance with ISO 10993 standards

2 Electrical Safety Testing

• Compliance with IEC 60601 series standards
• Electrical safety and protection testing

3 Software Validation Reports

• Applicable for:
  • Software as a Medical Device (SaMD)
  • Devices containing software
• Compliance with IEC 62304 standard

4 Cybersecurity Requirements

• Protection against unauthorized access
• Data security measures
• Risk mitigation for cyber threats

5 Performance Testing Reports

• Demonstrates device meets performance claims
• Accuracy, reliability, and functionality validation

Labeling and Instructions for Use (IFU)

1 Labels

Must be present on:

• Device
• Primary packaging
• Secondary packaging
• Shipping containers

Includes:

• Manufacturer details
• Model and serial number
• Manufacturing and expiry dates
• Regulatory information

2 Instructions for Use (IFU)

• Clear operating instructions
• Safety precautions
• Warnings and contraindications
• Maintenance instructions

Essential Principles Checklist

• Document demonstrating compliance with:
  • Safety requirements
  • Performance requirements
  • Regulatory standards
• Confirms device meets CDSCO essential safety and performance principles

Navigating Validity: Understanding Medical Device Licenses in India 

CDSCO medical device licenses in India operate differently from traditional expiry-based licenses.

• Licenses for medical device import and manufacturing are perpetual in nature once granted.

• Retention fees must be paid every five years to keep the licence valid.

• Failure to pay retention fees may result in suspension or cancellation of the licence.

• Companies should maintain compliance calendars to ensure timely retention fee payments and uninterrupted operations.

The Step-by-Step Journey: Preparing Technical File

Preparing a technical file for CDSCO submission involves a structured approach:

1. Correctly classify the device under MDR 2017 (Class A–D).
2. Compile administrative, technical, and clinical documentation.
3. Ensure QMS compliance with ISO 13485 and risk management per ISO 14971.
4. Complete all applicable testing reports, such as biocompatibility, electrical safety, and software validation.
5. Appoint an Authorized Indian Representative (AIR) for imported devices.
6. Upload documents and submit the application through the CDSCO SUGAM portal.
7. Respond promptly to CDSCO queries until license approval is granted.

Common Pitfalls: A Checklist to Avoid Technical File Rejection 

Navigating medical device regulations can be complex, and certain common mistakes often lead to application delays or rejections. Being aware of these can significantly improve your chances of a smooth approval process. 

1. Incomplete Documentation

Issue: Missing essential sections or sub-documents within the technical file.
Practical Tip: Use a detailed compliance checklist to ensure every required document is included before submission.

2. Lack of India-Specific Requirements

Issue: Assuming international regulatory files are directly transferable to India without modification.
Practical Tip: Always cross-reference your documentation with the Medical Device Rules, 2017 and relevant CDSCO guidance documents.

3. Insufficient Clinical Evidence

Issue: Inadequate or outdated Clinical Evaluation Reports (CERs), especially for higher-risk devices.
Practical Tip: Ensure your CER is robust, current, and relevant to the Indian patient population — or clearly justify its applicability.

4. Poor Quality Management System (QMS) Documentation

Issue: QMS certificates or procedures that are not compliant with ISO 13485 or are poorly documented.
Practical Tip: Conduct regular internal audits and update your QMS documentation to align with current ISO 13485 standards.

5. Outdated Standards and Testing Reports

Issue: Submitting test reports based on superseded international or national standards.
Practical Tip: Verify that all testing refers to the latest applicable standards, particularly:

• IEC 60601 (Electrical Safety)
• IEC 62304 (Medical Device Software)

6. Non-Compliance with Labelling Requirements

Issue: Labels, Instructions for Use (IFU), or packaging that do not meet CDSCO-specific content or language requirements.
Practical Tip: Ensure compliance with MDR 2017 and Legal Metrology requirements, including all mandatory warnings, symbols, and declarations.

7. Incorrect Device Classification

Issue: Misclassification of the medical device leading to the wrong application pathway or insufficient documentation.
Practical Tip: Follow CDSCO’s risk-based classification guidelines carefully. Seek expert advice if uncertain.

8. Inadequate Authorized Indian Representative (AIR) Information

Issue: Incomplete AIR details or appointing an AIR without the required wholesale license.
Practical Tip: Confirm that your AIR holds the necessary licenses for import and distribution under the State Licensing Authority and fully understands regulatory responsibilities.

9. Lack of Cybersecurity Documentation

Issue: Missing or insufficient cybersecurity evidence for connected or software-based medical devices.
Practical Tip: Include detailed cybersecurity framework documentation, risk assessments, threat analysis, and protection protocols in the technical file.

10. Unclear Responses to CDSCO Queries

Issue: Providing vague or incomplete responses to regulatory clarification requests.
Practical Tip: Respond promptly, clearly, and comprehensively. Attach all requested supporting documents to avoid delays.

The Consequences of Non-Compliance: What Happens If You Ignore It? 

Non-compliance with medical device regulations can seriously impact business operations:

• Delay or prohibition of product market entry

• Product recalls and reputational damage

• Financial penalties or legal action by authorities

The Investment: Understanding the Costs of Technical File Preparation and Submission 

The cost of bringing a medical device to market in India or internationally goes beyond just manufacturing. Preparing a comprehensive technical file and navigating the regulatory process involves several categories of expenses. These are not fixed figures but rather rough ranges, as they vary significantly based on device complexity, classification, existing documentation, and the services chosen. 

Cost Category	Rough Range (INR)
Consultancy Fees (Documentation & Regulatory Strategy)	₹50,000 – ₹500,000+
Testing Fees (Biocompatibility, Electrical Safety, Performance, Software)	₹100,000 – ₹2,000,000+
Government Application Fees (CDSCO)	₹1,000 – ₹50,000 per application
Authorised Indian Representative (AIR) Retainer Fees (Annual)	₹100,000 – ₹500,000+
QMS Implementation/Audit (ISO 13485 Certification)	₹200,000 – ₹1,000,000+
License Retention Fees (Every 5 years for CDSCO)	₹1,000 – ₹50,000 per device category

• Testing and certification costs vary based on device complexity and class.

• Quality Management System implementation and audits are essential investments.

• Foreign manufacturers must account for AIR service fees.

• Periodic licence retention fees are required for continued compliance.

How ELT Corporate Pvt. Ltd. Can Streamline Your Compliance Journey 

Navigating the intricacies of medical device technical file preparation and submission can be overwhelming, but you don’t have to do it alone. ELT Corporate Pvt. Ltd. specializes in providing comprehensive regulatory solutions to help manufacturers and importers achieve compliance for both CDSCO and international submissions. 

We offer expert guidance tailored to your specific device and target markets. Our team will meticulously review your existing documentation, identify gaps, and help you compile a robust technical file that meets all mandatory requirements, including those for ISO 13485, ISO 14971, IEC 60601, IEC 62304, and critical cybersecurity aspects. We ensure your documentation is not only compliant but also optimized for efficiency and reusability across different regulatory frameworks. 

For foreign manufacturers, ELT Corporate Pvt. Ltd. can serve as your dedicated Authorised Indian Representative (AIR), holding the appropriate license(s) for medical device import/distribution as required by the State Licensing Authority. We handle all official communications with CDSCO, manage queries, and oversee post-market surveillance activities, allowing you to focus on your core business. Our services extend to comprehensive support through the SUGAM portal submission process, ensuring accuracy and timely responses to CDSCO’s queries. 

From initial device classification and documentation support to application submission, query management, and even market entry strategy, ELT Corporate Pvt. Ltd. provides end-to-end assistance. We aim to simplify your compliance journey, accelerate your market access, and ensure your medical devices reach the patients who need them safely and efficiently. 

Conclusion

The medical device technical file remains central to regulatory approval and successful market access in India and globally. Compliance with CDSCO requirements, alignment with international standards, and proper documentation management help manufacturers reduce risks and accelerate approvals.

Businesses should regularly review documentation gaps and seek expert regulatory support to maintain smooth compliance and expansion into new markets.

FAQs 

Q1: What is the most common reason for CDSCO technical file rejection, and how can I avoid it? 

The most common reasons for CDSCO technical file rejections often include incomplete documentation or a failure to address India-specific regulatory requirements. Another frequent issue is insufficient clinical evidence, especially for Class C and D devices, which require more robust data to demonstrate safety and performance. 

To avoid rejection, always use a detailed medical device technical file checklist, ensuring all sections are fully completed and accurately represent your device. Make sure your clinical evaluation report (CER) is current and comprehensive. Additionally, verify that all quality management system (QMS) and risk management documentation aligns with the latest ISO 13485 and ISO 14971 standards, respectively. 

Q2: Can I use my EU MDR technical documentation for CDSCO submission without major changes? 

While EU MDR technical documentation provides a strong foundation, it cannot be used for CDSCO submission without significant adaptation and additions. Many core sections, such as device description, design information, and risk management, will have considerable overlap. 

However, CDSCO has specific administrative forms (e.g., MD-14, MD-15), requirements for the Plant Master File (PMF) and Device Master File (DMF), and mandatory local representation through an Authorized Indian Representative (AIR) with a valid wholesale license. You will also need to ensure compliance with India-specific labeling requirements and potentially local clinical data or bridging studies if required for higher-risk devices.

Q3: How long does it typically take to prepare a complete technical file for CDSCO submission? 

The time it takes to prepare a complete technical file for CDSCO submission varies significantly based on several factors. These include the device’s complexity, its risk classification (Class A, B, C, or D), and the completeness of your existing documentation. 

For a well-prepared manufacturer with most documents already in place, it might take a few weeks to compile and adapt for CDSCO. However, for a new device or a company starting from scratch, the process could range from several months to over a year, considering the time needed for testing, clinical evaluation, and QMS implementation. The typical CDSCO review process itself takes 3–6 months, but this timeframe can extend if queries arise. 

Q4: What are the cost implications of preparing a CDSCO technical file vs. international submissions? 

The cost implications for preparing a medical device technical file can vary considerably between CDSCO and international submissions. For CDSCO, costs typically include government application fees, fees for an Authorised Indian Representative (AIR), and ongoing licence retention fees every five years. 

International submissions, such as for EU MDR or US FDA, often involve higher notified body or FDA fees, extensive clinical studies for higher-risk devices, and specific local testing requirements. While many technical documents can be reused across markets, each region will have unique administrative, labelling, and potentially clinical data requirements that contribute to the overall cost. Engaging a regulatory consultant can help optimize these costs by identifying document reusability and efficient submission strategies. 

Q5: Do I need different technical files for different device classes under CDSCO? 

No, you generally don’t need entirely different technical files for each device class under CDSCO. Instead, the “depth” and “breadth” of the technical file’s contents will vary significantly depending on the device’s classification. 

Class A (low risk) devices require a more streamlined technical file, focusing on basic safety and performance. As you move up to Class B, C, and D (high risk), the required documentation becomes progressively more extensive. This includes more detailed design controls, comprehensive risk management, robust clinical evaluation reports, and additional testing evidence. All devices, however, must demonstrate compliance with essential principles of safety and performance, regardless of their class.