CDSCO License for Bed traction frame
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Intended to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).

Comprehensive Guide to CDSCO Licensing for Bed Traction Frames (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies in India, we understand the nuances and critical steps involved in securing a CDSCO license for medical devices like the Bed Traction Frame. This device, classified as Class A under the Indian regulatory framework, plays a vital role in orthopaedic care by providing physical support to patients with fractures and disorders of the spine and hip.
Understanding the Bed Traction Frame and Its Regulatory Importance
The Bed Traction Frame is intended specifically for treating orthopaedic conditions, such as fractures of the lower or cervical spine and hip disorders. As a physical support device, it falls under Class A – the lowest risk category according to CDSCO regulations. Despite its lower risk classification, obtaining the proper license is mandatory to ensure patient safety, regulatory compliance, and market access in India.
CDSCO Regulatory Framework for Bed Traction Frames (Class A Devices)
The regulatory oversight of Class A devices like the Bed Traction Frame is primarily managed by the State Licensing Authority. The licensing process is governed by the Medical Device Rules, facilitated through the CDSCO MD Online Portal, a centralized digital platform for application submission and tracking.
Risk Classification and License Requirements for Bed Traction Frames
According to the official Medical Device Classification guidelines, the Bed Traction Frame is classified as Class A due to its low risk profile. This classification necessitates an MD5 manufacturing license (Form MD3) for Indian manufacturers.
Key points:
- Risk Class: A
- License Type: MD5 Manufacturing License
- Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months including test license and audit
Manufacturing License Process for Bed Traction Frames (MD5 License)
Test License Application (Form MD13): The process begins with obtaining a test license, which allows the device to be manufactured for testing purposes. This takes about 1.5 to 2 months.
Product Testing: The Bed Traction Frame must be tested in government-approved laboratories to verify compliance with essential quality and safety standards. Refer to the Testing Laboratories list for approved facilities.
Document Preparation: Complete the necessary documentation, including Device Master File, Plant Master File, Risk Management File, and others detailed below.
Application Submission (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit will be conducted by a notified body to assess compliance with quality and manufacturing norms. You can check the list of notified bodies authorized for Class A device audits.
Query Resolution: Respond to any queries raised by the regulatory authority or notified body promptly to avoid delays.
License Grant (Form MD5): Upon successful audit and clearance of queries, the manufacturing license is issued.
Manufacturing License Documents Required for Bed Traction Frame (Class A)
Comprehensive documentation is critical for a smooth application process. For the Bed Traction Frame, ensure you have the following:
- Company Constitution Documents: Proof of legal entity and ownership.
- Proof of Ownership/Rental Agreement: For manufacturing premises.
- Technical Staff Details: Qualifications and experience certificates.
- Fire NOC and Pollution Control NOC: Compliance with safety and environmental norms.
- Device Master File (DMF): Detailed design, specifications, and manufacturing process. Our detailed Device Master File guide can help streamline this.
- Plant Master File (PMF): Manufacturing facility details; see our Plant Master File guide for best practices.
- Essential Principles Checklist: Confirming compliance with Indian medical device essential principles.
- Risk Management File: Documentation of risk analysis and mitigation measures, aligned with regulatory expectations. Learn more about risk management for medical devices.
- Test Reports: From government-approved labs validating device safety and performance.
- Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
- Quality Management System (QMS) Documents: Evidence of implemented QMS, typically ISO 13485:2016 certification.
Import License Process for Bed Traction Frames (MD15 License) - If Applicable
For importers wishing to bring Bed Traction Frames into India, the MD15 import license is required. This process is managed by the Central Licensing Authority and typically takes 5-6 months.
Steps include:
- Document preparation (including existing manufacturing licenses, Free Sale Certificates, ISO 13485:2016, CE Certificates).
- Application submission via the CDSCO MD Online Portal.
- Queries resolution.
- License issuance on Form MD15.
For detailed import license guidance, our Import License Guide provides valuable insights.
Timeline and Processing Duration for Bed Traction Frame Licensing
Step | Approximate Duration |
---|---|
Test License (Form MD13) | 1.5 - 2 months |
Product Testing | 1 - 1.5 months |
Document Preparation & Submission | 2 - 3 weeks |
Audit by Notified Body | 3 - 4 weeks |
Query Resolution & License Issuance | 2 - 3 weeks |
Total estimated time: 3 to 4 months from start to finish for the MD5 manufacturing license.
Government Fees and Costs for Bed Traction Frame Licensing
- Test License (MD13): No separate fee, included in overall process.
- MD5 Application Fees: INR 5,000 per application.
- Product Fee: INR 500 per product (per variant/model).
- Audit Fees: Paid directly to the notified body – varies by auditor but expect INR 50,000 to 1,00,000 depending on scope.
Common Challenges and Practical Solutions
- Delay in Test Report Generation: Coordinate early with government-approved testing labs to schedule testing and avoid bottlenecks.
- Incomplete Documentation: Use checklists and expert templates to ensure all required documents like Device Master Files and Risk Management Files are complete and compliant.
- Audit Non-Compliance: Pre-audit internal assessments can identify gaps. Engage notified bodies early to clarify expectations.
- Query Delays: Assign dedicated regulatory personnel to respond promptly and thoroughly to CDSCO queries.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, especially for first-time applicants. Our consultancy services provide:
- End-to-end application management.
- Document preparation and review.
- Coordination with testing laboratories and notified bodies.
- Audit readiness and QMS implementation support.
Our proven track record includes assisting manufacturers of orthopaedic and physical support devices like Bed Traction Frames to achieve timely approvals and market entry.
Getting Started with Your CDSCO License Application for Bed Traction Frames
- Assess Your Device Classification: Confirm the risk class as Class A and determine licensing needs.
- Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
- Engage Testing Labs: Schedule testing with an approved laboratory early to avoid delays.
- Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal.
- Plan Your Audit: Identify a notified body from the official list and prepare for inspection.
- Submit Manufacturing License Application: Once test reports and documents are ready, file Form MD3.
- Monitor and Respond: Stay proactive in resolving queries from CDSCO and the auditor.
By following these strategic steps and leveraging expert support, manufacturers can efficiently navigate the regulatory pathway for Bed Traction Frames, enabling safe and compliant access to the Indian healthcare market.
For more detailed assistance, connect with us to leverage our extensive expertise in CDSCO licensing for Class A medical devices.