CDSCO License for Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Introduction to Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid and Regulatory Importance

The Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid is a cutting-edge software medical device designed to assist clinicians in evaluating traumatic brain injuries through detailed analysis of patients’ eye movements. As a prescription device, it provides critical insights into the functional condition of the brain, enabling informed clinical decisions. Given its clinical significance and software complexity, this device falls under Class C risk classification by the Central Drugs Standard Control Organization (CDSCO), necessitating stringent regulatory compliance.

Navigating the CDSCO licensing process for such software is vital to ensure market access in India, uphold patient safety, and meet statutory requirements. With over 25 years of experience and having supported 500+ companies, we provide expert guidance on acquiring the necessary MD9 manufacturing license and import clearance for this device category.

CDSCO Regulatory Framework for Software-Based Medical Devices

Software medical devices like the Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid are regulated under the Medical Device Rules (MDR) 2017, overseen by CDSCO. The software is treated as a medical device due to its intended medical purpose. Regulatory focus includes software validation, risk management, clinical evaluation, cybersecurity, and compliance with Essential Principles.

The device-specific notification (29/Misc./03/2020-DC (198)) dated 13.9.2021 classifies it as Class C, reflecting moderate to high risk, mandating central licensing authority approval.

Risk Classification and License Requirements for Class C Software Devices

Class C devices, including this software, require an MD9 manufacturing license granted by the CDSCO Central Licensing Authority. This classification demands rigorous adherence to quality management systems (ISO 13485:2016), clinical evidence, and comprehensive documentation.

To legally manufacture or import the device in India, the following licenses are necessary:

• MD9 Manufacturing License (Form MD7) for local manufacturers
• MD15 Import License (Form MD14) for importers

Both licenses ensure compliance with Indian MDR and safeguard end-user safety.

Manufacturing License Process for MD9 (Class C Devices)

For manufacturers of this software device in India, the MD9 license process involves several key steps:

1. Test License (Form MD13): Obtain a test license to conduct product testing. This typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at one of the government-approved laboratories. Check the Testing Laboratories list for authorized centers.
3. Documentation Preparation: Compile detailed documentation including Device Master File, Plant Master File, Risk Management File, and clinical evaluation reports.
4. Application Submission (Form MD7): Apply online via the CDSCO MD Online Portal for the MD9 license.
5. Audit/Inspection: CDSCO inspectors conduct facility audits and assessment of quality systems.
6. Queries Resolution: Address any queries or deficiencies raised during the audit.
7. License Grant: Upon satisfactory compliance, CDSCO issues the MD9 manufacturing license.

The entire process averages 4 to 5 months.

For a deep dive into each step, consult our detailed MD9 License Guide.

Manufacturing License Documents Required for Brain Injury Assessment Software

Manufacturers must submit comprehensive documentation as part of the MD9 application:

• Company Constitution and Incorporation Certificate
• Proof of Premises Ownership or Lease Agreement
• Details of Technical Staff (Qualification and Experience)
• Fire and Pollution NOCs
• Device Master File (DMF) detailing software specifications, design validation, and clinical evaluation (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing infrastructure and quality control (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File as per ISO 14971 standards (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation aligned with ISO 13485:2016

Thorough preparation of these documents reduces audit queries and accelerates approval.

Import License Process (MD15) for Brain Injury Adjunctive Software

Importers of this Class C medical device must secure an MD15 license from the CDSCO Central Licensing Authority. The process typically spans 5 to 6 months and includes:

1. Document Compilation: Prepare all mandatory documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, and wholesale license.
2. Application Submission (Form MD14): File the import license application via the CDSCO MD Online Portal.
3. Queries Resolution: Address any clarifications from CDSCO.
4. License Issuance: Post verification, CDSCO grants the MD15 import license.

Refer to our Import License Guide for detailed steps.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Certificate
• Product labels and IFU

Completeness of documentation is critical to prevent processing delays.

Timeline and Processing Duration

*MD9 timeline includes test license, testing, audit, and license grant stages.

Planning your regulatory submission timeline accordingly is essential for market entry.

Government Fees and Costs for Class C Software Device

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
• Test License (MD13): Included within MD9 process fees
• MD15 Import License:
  • Class C: $3,000 per site +$1,500 per product

Budgeting for fees, testing, audit, and consultancy is necessary to avoid surprises.

Common Challenges and Solutions

Challenge 1: Complex Documentation Preparation

• Many manufacturers face difficulty compiling robust Device Master File and Risk Management documentation.
• Solution: Engage regulatory experts early; use templates aligned with CDSCO requirements.

Challenge 2: Testing Delays at Government Labs

• Backlogs can delay product testing.
• Solution: Schedule testing promptly after test license approval; consider alternative approved labs.

Challenge 3: Audit Preparedness

• Non-compliance with QMS or plant documentation can trigger audit observations.
• Solution: Conduct pre-audit internal reviews and staff training.

Challenge 4: Query Resolution Delays

• Slow response to CDSCO queries prolongs licensing.
• Solution: Assign dedicated regulatory personnel for timely communication.

Expert Consultation and Support

With extensive experience assisting over 500 medical device companies, we offer tailored regulatory consulting to streamline your CDSCO licensing journey. Our services include:

• Gap analysis of documentation and QMS
• Preparation and review of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Application filing and follow-up on the CDSCO MD Online Portal
• Audit readiness coaching and query management

Partnering with seasoned consultants significantly reduces approval time and ensures compliance.

Getting Started with Your CDSCO MD9 License Application

1. Assess Your Product Classification: Confirm Class C categorization and applicability of MD9 license.
2. Initiate Test License Application (Form MD13): Submit your test license application via the CDSCO MD Online Portal.
3. Engage a CDSCO-Approved Testing Laboratory: Schedule product testing early to avoid bottlenecks.
4. Compile Comprehensive Documentation: Prepare your Device Master File, Risk Management File, and other required documents following official guidelines.
5. Plan for Audit and Inspection: Develop QMS and plant records; arrange staff training.
6. Submit MD9 License Application (Form MD7): File through the CDSCO portal, ensuring all documents are complete.
7. Address Queries Promptly: Maintain open channels with CDSCO inspectors for swift resolution.

For detailed assistance, contact our regulatory experts who specialize in Class C software medical devices. Our dedicated support can help you navigate the complexities, ensuring your Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid reaches the Indian market efficiently and compliantly.