CDSCO License for Ataxiagraph With Interpretive Software

Introduction to Ataxiagraph With Interpretive Software and Its Regulatory Importance

Ataxiagraph with Interpretive Software is a Class A medical device designed to assess the extent of ataxia—a neurological condition characterized by impaired muscular coordination. By measuring body sway when a patient stands erect with eyes closed, and providing clinical interpretation, this software-based device plays a crucial role in neurological diagnostics. Given its medical purpose and patient safety implications, compliance with Indian regulatory standards is mandatory before marketing or manufacturing.

Navigating the Central Drugs Standard Control Organization (CDSCO) licensing framework ensures your Ataxiagraph software meets all safety, quality, and efficacy requirements. With over 25 years of experience assisting 500+ companies, we provide expert insights on the CDSCO licensing process specifically tailored for Class A software medical devices like this.

CDSCO Regulatory Framework for Ataxiagraph Software

The CDSCO regulates medical devices under the Medical Device Rules, 2017. Your Ataxiagraph falls under Class A (low risk) as a software device used for diagnostic aid. The regulatory route involves obtaining a manufacturing license (MD5) from the State Licensing Authority. Importers, on the other hand, require an Import License (MD15) from the Central Licensing Authority.

This two-tier regulation ensures thorough quality control while facilitating faster market entry for low-risk devices.

Risk Classification and License Requirements

• Device Risk Class: A (Low Risk)
• Applicable License: MD5 Manufacturing License (Form MD3)
• Regulatory Authority: State Licensing Authority
• Process Overview: Test license (MD13) → Product testing → Documentation → Application submission → Audit by notified body → License grant

Understanding your risk classification is critical. Class A devices like Ataxiagraph require a less rigorous but structured process compared to Class C or D devices, balancing safety with efficiency.

Manufacturing License Process for Ataxiagraph (MD5 License)

1. Obtain Test License (Form MD13): Initiate with a test license that allows sample testing, taking approximately 1.5 to 2 months.
2. Product Testing: Conduct product performance and safety testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list for accredited facilities.
3. Document Preparation: Compile required documentation including Device Master File, Plant Master File, Risk Management File, and others.
4. Application Submission (Form MD3): File the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an on-site audit by a notified body listed on the Notified Bodies list.
6. Queries & Clarifications: Respond promptly to any queries raised by the licensing authority or notified body.
7. Grant of License (Form MD5): Upon satisfactory review, the manufacturing license is granted.

For detailed procedural guidance, consult our MD5 License Guide.

Manufacturing License Documents Required for Ataxiagraph

A comprehensive dossier is essential for smooth license approval. Key documents include:

• Company Constitution Documents: Proof of legal entity and registration.
• Proof of Ownership/Lease of Premises: Valid documents showing manufacturing site ownership or lease.
• Technical Staff Qualifications: Details and CVs of personnel involved in manufacturing.
• Fire NOC & Pollution Control NOC: Safety and environmental compliance certificates.
• Device Master File: Detailed technical specifications and design data. Our Device Master File Guide offers best practices.
• Plant Master File: Description of manufacturing facilities and quality controls. Learn more in our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with CDSCO’s essential principles.
• Risk Management File: Evidence of identified risks and mitigation strategies as per ISO 14971 standards. See our Risk Management guide.
• Test Reports: From government-approved labs validating device safety and effectiveness.
• Labels and Instructions for Use (IFU): As per CDSCO guidelines.
• Quality Management System Documents: ISO 13485 certification and SOPs relevant to manufacturing.

Import License Process for Ataxiagraph (MD15 License)

If you plan to import Ataxiagraph software into India, the process differs:

1. Document Preparation: Collect manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission (Form MD14): Submit the import license application on the CDSCO MD Online Portal.
3. Query Resolution: Address any department queries promptly.
4. Grant of Import License (Form MD15): License issued typically within 5-6 months.

Refer to our Import License Guide for detailed steps and document checklists.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Planning your project timeline with these steps in mind will minimize delays and unexpected bottlenecks.

Government Fees and Costs

For Ataxiagraph classified as Class A:

• Test License (MD13): Approximately INR 5,000
• Manufacturing License Application Fee (MD5): INR 5,000 per application
• Product Fee: INR 500 per product

Additional costs include audit fees charged by notified bodies and testing laboratory fees, which vary based on the scope and device complexity.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent documents often delay approval. Use detailed checklists and expert reviews to ensure completeness.
• Delayed Testing Results: Partner with accredited labs early to schedule timely testing.
• Audit Non-Compliance: Prepare your manufacturing site thoroughly by conducting internal audits and corrective actions before notified body visits.
• Understanding Regulatory Nuances: Stay updated with CDSCO notifications such as Notification 29/Misc./03/2020-DC (198) dated 13.9.2021 governing software devices.

Our proven approach and hands-on experience help clients overcome these hurdles efficiently.

Expert Consultation and Support

With over 25 years of expertise, we have supported 500+ manufacturers and importers in securing CDSCO licenses seamlessly. Our team offers:

• Tailored regulatory strategy for Class A software devices
• Complete document preparation and gap analysis
• Coordination with notified bodies and testing labs
• Post-license compliance and audit readiness

Engage with us early in your product development cycle to optimize timelines and resources.

Getting Started with Your CDSCO License Application for Ataxiagraph

1. Assess Your Product Classification: Confirm Class A status using the Medical Device Classification tool.
2. Initiate Test License Application: Submit Form MD13 through the CDSCO MD Online Portal to commence product testing.
3. Schedule Testing with Accredited Labs: Contact listed labs to plan timely testing.
4. Prepare Comprehensive Documentation: Utilize our Device and Plant Master File guides to assemble required documents.
5. Engage a Notified Body: Identify and appoint a notified body from the official Notified Bodies list for audit scheduling.
6. Submit Manufacturing License Application (MD3): Once testing and documentation are complete, apply for the MD5 license.
7. Plan for Audit and Query Resolution: Prepare your site and team for the audit and any follow-up queries.

Embarking on this structured pathway ensures compliance and expedites your Ataxiagraph’s entry into the Indian market. For personalized assistance, contact us today.

Leverage our deep regulatory knowledge to transform your Ataxiagraph software into a compliant, market-ready medical device in India.