CDSCO License for Horizontal non-powered traction system

Comprehensive Guide to CDSCO License for Horizontal Non-Powered Traction System (Class A Medical Device)

Introduction: Understanding Your Device and Regulatory Importance

The Horizontal Non-Powered Traction System is a Class A medical device designed to provide constant horizontal traction forces to cervical or lumbar vertebrae. Intended to be attached to treatment tables, it aids physical support therapy by utilizing harnesses while patients lie supine. Given its intended use and classification, obtaining the correct CDSCO license is not only mandatory but also essential to ensure compliance with Indian regulatory standards and patient safety.

Navigating the regulatory framework can be complex, but with over 25 years of experience assisting 500+ companies, we provide actionable insights to help you secure your CDSCO license smoothly.

CDSCO Regulatory Framework for Horizontal Non-Powered Traction Systems

In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO). For physical support devices like the Horizontal Non-Powered Traction System, classified as Class A (low risk), the licensing process falls under the purview of State Licensing Authorities through the MD5 license route.

This regulatory framework ensures that devices meet essential safety, quality, and performance standards before entering the Indian market. Compliance involves device testing, quality management systems, and audits.

Risk Classification and License Requirements

The Horizontal Non-Powered Traction System is categorized as a Class A medical device under the CDSCO classification system. Class A devices are considered low risk and require a manufacturing license under Form MD3, leading to an MD5 license.

• License Type: MD5 Manufacturing License
• Governing Authority: State Licensing Authority
• Application Form: MD3

Understanding your device’s risk class is critical as it determines the licensing pathway, documentation, fees, and audit requirements. For more on medical device classification, visit our detailed Medical Device Classification guide.

Manufacturing License Process (MD5)

The process for obtaining an MD5 license involves several key steps:

1. Test License Application (Form MD13): Before full manufacturing license application, you must secure a test license to legally manufacture the device during evaluation (approx. 1.5 to 2 months).
2. Product Testing: Conduct product testing at CDSCO-approved laboratories to ensure compliance with Indian standards. Refer to the list of testing laboratories for authorized facilities.
3. Documentation Preparation: Prepare comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. License Application Submission: Apply for the manufacturing license using Form MD3 via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct an audit of your manufacturing facility and documentation. Check the list of notified bodies to select the appropriate auditor.
6. Query Resolution: Address any queries or observations raised by the department or the auditor promptly.
7. License Grant: Upon successful audit and compliance, the State Licensing Authority issues the MD5 license (Form MD5).

Manufacturing License Documents Required

For a Class A device like the Horizontal Non-Powered Traction System, prepare the following documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) – detailed device description, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) – information about the manufacturing site and quality systems (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File tailored to device hazards (Risk Management guide)
• Product Test Reports from CDSCO-approved labs
• Sample Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15)

Though primarily focused on manufacturing licenses, we understand some manufacturers or distributors may import this device. For import, an MD15 license is mandatory, governed centrally by CDSCO.

Key steps include:

• Preparing necessary import documentation including manufacturing license, free sale certificate, ISO 13485:2016, CE certificate, DMF, PMF, company constitution, and wholesale license.
• Applying online through the CDSCO MD Online Portal using Form MD14.
• Responding to any departmental queries.
• Awaiting grant of MD15 license.

Import license timelines typically span 5-6 months.

Import License Documents Required

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

Timeline and Processing Duration

Total Estimated Time: Approximately 3-4 months from test license to MD5 license grant.

Government Fees and Costs

For a Class A device:

• Application Fee: INR 5,000 per application
• Product Fee: INR 500 per product

Additional costs may include testing fees at approved labs (varies per test), audit fees charged by notified bodies, and consultancy fees if external support is engaged.

Common Challenges and Solutions

• Delay in Product Testing: Coordinate early with CDSCO-approved labs and pre-book testing slots to avoid bottlenecks.
• Incomplete Documentation: Follow comprehensive checklists and templates for DMF, PMF, and risk management files to ensure completeness.
• Audit Non-Compliance: Conduct pre-audit internal assessments to identify and rectify gaps in facility and QMS.
• Query Resolution Delays: Assign dedicated personnel to respond promptly to CDSCO queries to keep the process on track.

Expert Consultation and Support

With extensive experience assisting over 500 medical device companies, we provide tailored consulting to:

• Interpret regulatory requirements specific to your device
• Prepare and review documentation meticulously
• Liaise with CDSCO authorities and notified bodies
• Manage timelines and compliance effectively

Our proven approach minimizes delays and maximizes your success rate in obtaining CDSCO licenses.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm that your Horizontal Non-Powered Traction System qualifies as Class A.
2. Prepare Test License Application (MD13): Begin by applying for the test license through the CDSCO MD Online Portal.
3. Engage an Approved Testing Laboratory: Schedule product testing early to align with your test license timeline.
4. Compile Comprehensive Documentation: Utilize our guides on Device Master File and Plant Master File to ensure regulatory compliance.
5. Plan for Notified Body Audit: Select an appropriate notified body from the official list and prepare your facility.
6. Submit MD5 License Application: After successful testing and document readiness, submit Form MD3 via the CDSCO portal.
7. Implement a Query Response Strategy: Establish a dedicated team to handle regulatory queries swiftly.

Taking these practical steps will position you for a successful and timely license grant, enabling you to bring your Horizontal Non-Powered Traction System to the Indian market confidently.

For personalized assistance, detailed templates, and end-to-end support, contact our expert regulatory consultants who have navigated the CDSCO licensing landscape for hundreds of clients successfully.