CDSCO License for Traction table, line- powered
Medical Device Information
Intended Use
Intended to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine.
Introduction to Traction Table (Line-Powered) and Its Regulatory Significance
A traction table, line-powered, is a specialized medical device designed to support patients and deliver mechanical traction therapy to back muscles and the spine—specifically targeting lumbar and cervical regions. This motorized physical support device plays a crucial role in rehabilitation and pain management. Given its direct patient contact and mechanical operation, regulatory oversight ensures safety and efficacy before market entry.
At our consultancy, with over 25 years of experience and having assisted 500+ companies, we understand that navigating the Central Drugs Standard Control Organization (CDSCO) licensing pathway can be complex. This guide demystifies the process for this Class B device, helping manufacturers and importers prepare compliant applications and avoid common pitfalls.
CDSCO Regulatory Framework for Traction Tables (Class B Medical Devices)
Traction tables fall under the physical support category and are classified as Class B devices by CDSCO, indicating a low to moderate risk level. The regulatory framework requires obtaining a manufacturing license (MD5) from the State Licensing Authority or an import license (MD15) from the Central Licensing Authority, depending on your business model.
The device is notified under File No. 29/Misc./03/2020-DC (202) dated 26.7.2021, aligning it with current CDSCO regulations and compliance standards.
Risk Classification and License Requirements for Traction Tables
- Risk Class: B (Low-Moderate risk)
- License Type: MD5 License for manufacturing (Form MD3)
- Regulatory Authority: State Licensing Authority
- Test License: Required (Form MD13)
For Class B devices like the traction table, the MD5 license process is the standard route, involving product testing, documentation, and audit by a notified body.
Manufacturing License Process (MD5) for Traction Table
- Apply for Test License (Form MD13): Initiate with a test license application allowing product testing for approximately 1.5 to 2 months.
- Product Testing: Conduct testing at CDSCO-approved laboratories to validate device safety and performance.
- Documentation Preparation: Compile all mandatory documents, including Device Master File and Plant Master File.
- Submit MD5 License Application (Form MD3): File your formal application through the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body listed here will conduct a comprehensive audit.
- Respond to Queries: Address any clarifications or queries raised by the authority or notified body promptly.
- License Grant: Upon successful review and audit, the MD5 license is issued.
Refer to our detailed MD5 License Guide for a step-by-step walkthrough.
Manufacturing License Documents Required for Traction Table
- Company Constitution (e.g., Memorandum and Articles of Association)
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Qualification and Experience Documents
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design and specifications (Guide)
- Plant Master File (PMF) outlining manufacturing processes (Guide)
- Essential Principles Checklist demonstrating compliance
- Risk Management File (Risk Management Practices)
- Test Reports from CDSCO-approved labs (Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485 certified
Ensuring this documentation is thorough and well-organized significantly reduces processing delays.
Import License Process (MD15) for Traction Table
If you are an importer, the MD15 license issued by the Central Licensing Authority is mandatory. For Class B devices, the process includes:
- Document preparation (Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, Company Constitution)
- Application submission on the CDSCO MD Online Portal
- Resolution of any queries raised
- License issuance on Form MD15
The import license process typically takes about 5 to 6 months, with fees scaled based on device class.
More details are available in our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | Variable (typically 2-3 weeks) |
| MD5 License Application Review | 1 month |
| Audit and Query Resolution | 2-3 weeks |
| Total Estimated Time | 3 to 4 months |
Manufacturers should plan accordingly to accommodate these timelines and avoid last-minute rush.
Government Fees and Costs
- Test License (MD13): Usually included in the overall process
- MD5 License Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Additional costs include fees for notified body audits and laboratory testing, which vary based on scope and complexity.
Common Challenges and Solutions
- Incomplete Documentation: Missing or inconsistent documents cause delays. Solution: Use comprehensive checklists and cross-verify all files before submission.
- Delays in Product Testing: Limited slots in government-approved labs may extend timelines. Solution: Book test slots early and consider multiple labs from the Testing Laboratories list.
- Audit Non-Compliance: Lack of preparedness for notified body audits can lead to rejections. Solution: Conduct internal audits and readiness assessments.
- Query Resolution Delays: Slow responses to authority queries prolong processing. Solution: Assign dedicated regulatory personnel for swift communication.
Expert Consultation and Support
With decades of expertise and a track record of 500+ successful CDSCO licenses, we provide end-to-end support—from documentation, product testing coordination, to audit readiness and application submission. Our tailored approach ensures compliance with the latest regulatory updates and minimizes the risk of application rejection.
Getting Started with Your CDSCO License Application for Traction Table
- Assess Your Product Classification: Confirm your device is Class B as per CDSCO Medical Device Classification.
- Prepare Your Documentation: Begin compiling your Device Master File, Plant Master File, and risk management documentation.
- Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with approved labs early.
- Organize Your QMS and Facility: Ensure your manufacturing site complies with CDSCO standards.
- Initiate MD5 Application: After test reports, submit your Form MD3 and prepare for notified body audit.
For detailed guidance and personalized assistance, contact our regulatory consultants who specialize in Class B medical devices. Let us help you streamline your CDSCO licensing journey and successfully launch your traction table in the Indian market.
