CDSCO License for Computerized Cognitive Assessment Aid For Concussion
Medical Device Information
Intended Use
For use as an assessment aid in the management of concussion.
Comprehensive Guide to CDSCO Licensing for Computerized Cognitive Assessment Aid For Concussion (Class C Software Device)
Navigating the regulatory landscape in India for medical devices can be complex, especially for innovative software-based solutions like the Computerized Cognitive Assessment Aid For Concussion. As a Class C medical device under the CDSCO framework, this software requires a rigorous approval process to ensure safety and efficacy in concussion management. With over 25 years of regulatory consulting experience and more than 500 successful client approvals, we provide you with a detailed roadmap for obtaining your CDSCO license efficiently and compliantly.
CDSCO Regulatory Framework for Computerized Cognitive Assessment Aid For Concussion
This device is categorized as software intended to assist clinicians in evaluating cognitive function following a concussion. According to the CDSCO notification [29/Misc./03/2020-DC (198)] dated 13.9.2021, such software falls under Class C, denoting moderate to high risk. Consequently, it is regulated stringently by the Central Licensing Authority through the MD9 licensing pathway.
The regulatory requirements are designed to ensure that the software meets essential principles related to safety, performance, and data security, in addition to adherence to Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).
Risk Classification and License Requirements
- Device Risk Class: C (Moderate to high risk)
- License Type: MD9 Manufacturing License
- Authority: Central Licensing Authority (CDSCO HQ)
- Application Form: MD7
As a Class C device, the licensing process includes mandatory product testing, document verification, and inspection by CDSCO officials.
Manufacturing License Process for Class C Software Devices (MD9 License)
Test License Application (Form MD13): Before manufacturing, you must obtain a test license, which authorizes product testing. This stage typically takes 1.5 to 2 months.
Product Testing: Conduct tests at CDSCO-approved government laboratories to demonstrate compliance with relevant standards. You can find a list of recognized labs on the CDSCO Testing Laboratories page.
Document Preparation: Compile all required documents, including technical files and Quality Management System documentation.
Submit MD9 Application (Form MD7): Apply online through the CDSCO MD Online Portal.
Audit and Inspection: CDSCO inspectors will conduct facility audits and review your documentation.
Query Resolution: Address any clarifications or additional information requests from the CDSCO.
License Grant (Form MD9): Upon satisfactory compliance, the license is granted.
You can explore our detailed MD9 License Guide for a step-by-step walkthrough.
Manufacturing License Documents Required for Computerized Cognitive Assessment Aid
To ensure a smooth application, prepare the following:
- Company Constitution Documents (Incorporation certificate, PAN, GST)
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Qualifications and Experience
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed description of the software, algorithms, intended use, and clinical evaluation. See our Device Master File Guide.
- Plant Master File (PMF): Description of the manufacturing facility, processes, and quality controls. Learn more in our Plant Master File Guide.
- Essential Principles Compliance Checklist
- Risk Management File: Documented risk analysis and mitigation strategies as per ISO 14971. Our Risk Management resource can help.
- Test Reports: From CDSCO-recognized labs validating software performance and safety.
- Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal procedures.
Import License Process for Class C Devices (MD15 License)
If you are an importer of this software device, the MD15 import license is mandatory. The process involves:
- Document preparation including the manufacturing license from the country of origin, Free Sale Certificate, and ISO 13485:2016 certification.
- Submission of the application through the CDSCO portal in Form MD14.
- Query resolution with CDSCO.
- Grant of the MD15 license.
The MD15 process typically takes 5-6 months. For detailed steps and document checklist, refer to our Import License Guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 – 2 weeks |
| MD9 Application Processing | 2 – 3 months |
| Total Time Estimate | 4 – 5 months |
This timeline assumes prompt responses to queries and well-prepared documentation.
Government Fees and Costs
- MD9 Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
- Additional costs for:
- Product testing at government labs (varies by test scope)
- Notified body audit fees (varies by auditor)
Budget for around ₹55,000 – ₹70,000 excluding testing and audit fees for the initial license.
Common Challenges and Solutions
- Incomplete Documentation: Missing technical or QMS documents cause delays. Solution: Prepare a comprehensive checklist and cross-verify before submission.
- Test Report Delays: Government labs may have backlogs. Solution: Engage testing early and consider parallel document preparation.
- Audit Non-Compliance: Deficiencies in facility or QMS during audit. Solution: Conduct internal mock audits and train staff thoroughly.
- Query Management: Delayed responses to CDSCO queries prolong timelines. Solution: Assign dedicated regulatory personnel for swift clarifications.
Expert Consultation and Support
Given the complexities of Class C software device licensing, expert guidance is invaluable. We offer tailored consultancy services covering:
- Preparation of Device and Plant Master Files
- Risk management implementation
- Liaison with CDSCO and notified bodies
- Audit preparedness
- End-to-end application management
Our proven track record with over 500 successful CDSCO licenses ensures your application navigates regulatory hurdles smoothly.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm Class C status using CDSCO guidelines or our Medical Device Classification tool.
Initiate Test License Application: Prepare and submit Form MD13 through the CDSCO MD Online Portal.
Engage with Testing Labs: Schedule product testing early to avoid bottlenecks.
Compile Documentation: Begin drafting the Device Master File, Plant Master File, and risk management documents.
Plan for Audit: Identify and prepare your manufacturing site and quality system for the upcoming CDSCO inspection.
Submit MD9 Application: Once test results are finalized, submit Form MD7.
Respond to Queries Promptly: Designate a regulatory liaison to handle CDSCO communications.
By following these actionable steps and leveraging expert support, manufacturers and importers of computerized cognitive assessment software for concussion can successfully enter the Indian market with full CDSCO compliance.
For personalized assistance or to initiate your application process, please contact our regulatory team today.
