CDSCO License for External Ring fixation system
Medical Device Information
Intended Use
The Ring Fixation System consists of series of external fixators intended to be used to stabilize bone segment in a broad range of indications,including fractures, joint fusion, bone transport, lengthening & angular corrections. The system includes Half Rings 5/8 Ring, Rings With Curved Extremities, Italian Femoral Arches, Arches With Holes, Threaded Rods, Telescopic Rods, Post- Male/ Female, Hinges-Male/ Female/Standard, Long/Short Connection Plates, Connected Plates With Threaded Ends, Twisted/Curved Plates, Bushing Threaded Sockets, Connection Bolts, Nut, Washers, Bolt, Multiple, Wire Fixation Buckle, Blocks for Half Pins, Universal Joint, Rotational and Translational Device, Oblique Support, Set Screw, Foot Rings, Knurling post male. Implants not included.
Introduction to External Ring Fixation System and Regulatory Importance
The External Ring Fixation System is a sophisticated assembly of external fixators designed to stabilize bone segments across a variety of orthopedic applications such as fractures, joint fusion, bone transport, lengthening, and angular corrections. This device category, classified under General Hospital or Orthopaedic Instruments, plays a critical role in orthopedic surgery but excludes implants. Given its risk classification as Class B under Indian medical device regulations, obtaining the appropriate CDSCO license is mandatory before manufacturing or marketing this device in India.
With over 25 years of experience assisting more than 500 companies in the Indian medical device space, we understand the nuances of the CDSCO regulatory framework and can guide you through the entire licensing process seamlessly.
CDSCO Regulatory Framework for External Ring Fixation System
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, which came into effect on January 1, 2018. The External Ring Fixation System, notified under Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, falls under Class B (Low-Moderate Risk) devices.
As per MDR, Class B devices require an MD5 manufacturing license issued by the State Licensing Authority. The regulatory controls include mandatory product testing, audit by a notified body, and submission of comprehensive technical documentation.
Risk Classification and License Requirements for External Ring Fixation System
- Risk Class: B (Low-Moderate Risk)
- Applicable License: MD5 License (Application Form MD3)
- Licensing Authority: State Licensing Authority
- Regulatory Notifications: 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022
This classification ensures the device undergoes appropriate scrutiny without the more rigorous requirements applicable to higher-risk devices.
Manufacturing License Process (MD5) for External Ring Fixation System
The MD5 license process for Class B devices typically spans 3 to 4 months and involves several critical steps:
Test License Application (Form MD13): Before applying for the manufacturing license, a test license is required to conduct product testing. This process usually takes 1.5 to 2 months.
Product Testing: The device samples must be tested at CDSCO-approved government laboratories. Testing validates compliance with applicable standards.
Document Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents must be meticulously prepared.
Application Submission (Form MD3): The manufacturing license application is submitted through the CDSCO MD Online Portal.
Audit by Notified Body: A CDSCO-recognized notified body will conduct an on-site audit of your manufacturing facility. You can check the list of notified bodies authorized for MD5 audits.
Query Resolution: Address any queries raised by the CDSCO or notified body promptly to prevent delays.
Grant of License (Form MD5): Once all requirements are met satisfactorily, the State Licensing Authority grants the MD5 manufacturing license.
Manufacturing License Documents Required for External Ring Fixation System
To ensure a smooth application process, prepare the following documents:
- Company Constitution Documents: Registration certificate, Memorandum and Articles of Association.
- Proof of Premises Ownership or Lease Agreement: Valid ownership or lease documents.
- Technical Staff Details: Qualification and experience certificates of key personnel.
- Fire NOC: No Objection Certificate from the fire department.
- Pollution NOC: Environmental clearance documentation.
- Device Master File (DMF): Detailed design and manufacturing process documentation. For guidance, see our comprehensive Device Master File guide.
- Plant Master File (PMF): Details of your manufacturing facility. Learn how to create this in our Plant Master File guide.
- Essential Principles Checklist: Demonstrating compliance with essential safety and performance principles.
- Risk Management File: Documenting identified risks and mitigation measures. Refer to our Risk Management guide.
- Test Reports: From government-approved labs. See the list of testing laboratories.
- Labels and Instructions for Use (IFU): Accurate and compliant labeling and user manuals.
- Quality Management System (QMS) Documents: Including ISO 13485:2016 certification where applicable.
Import License Process (MD15) for External Ring Fixation System
If you plan to import the External Ring Fixation System into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process typically takes 5 to 6 months and involves:
Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale license, and Company Constitution.
Application Submission: Apply through the CDSCO MD Online Portal.
Query Resolution: Engage promptly with CDSCO for any clarifications.
Grant of Import License (Form MD15): Upon successful review, license is granted.
Costs vary by device risk class; for Class B devices, fees are approximately 1000 per product.
For detailed guidance, explore our Import License guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (Form MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| Application Processing (MD5) | 1 – 2 months |
| Audit and Query Resolution | 3 – 4 weeks |
| Total Estimated Time | 3 – 4 months |
These timelines may vary based on preparedness and prompt response to queries.
Government Fees and Costs Associated with MD5 License
- Application Fee: Rs 5,000 per application.
- Product Fee: Rs 500 per product.
Additional costs to consider:
- Testing laboratory fees charged by government approved labs.
- Fees for the notified body audit.
- Consultancy and documentation preparation costs if you engage expert support.
Common Challenges and Practical Solutions
Challenge: Delay in product testing due to limited slots at government labs.
Solution: Plan early and submit test license applications well in advance to secure lab slots. Consider multiple approved labs to reduce bottlenecks.
Challenge: Incomplete documentation leading to multiple rounds of queries.
Solution: Utilize comprehensive checklists for all required documents. Engage experienced consultants to review your submission.
Challenge: Audit non-compliance due to gaps in Quality Management System or facility standards.
Solution: Conduct internal audits before the notified body inspection. Train your technical staff thoroughly.
Challenge: Regulatory updates causing confusion.
Solution: Stay updated with the latest notifications from CDSCO and seek expert advice regularly.
Expert Consultation and Support
Navigating the CDSCO licensing process for Class B devices like the External Ring Fixation System requires specialized knowledge of regulatory requirements, documentation standards, and procedural workflows. Our team of regulatory consultants has successfully guided over 500 manufacturers and importers through this process.
We provide:
- End-to-end application preparation and submission.
- Assistance with Device and Plant Master File creation.
- Coordination with notified bodies and testing laboratories.
- Pre-audit readiness assessments.
- Post-license compliance support.
Engage with us early in your licensing journey to avoid costly delays and ensure regulatory compliance.
Getting Started with Your CDSCO License Application for External Ring Fixation System
Assess Device Classification: Confirm that your device is Class B as per the Medical Device Classification guidelines.
Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal to initiate product testing.
Identify Testing Laboratory: Choose from the list of approved testing laboratories and coordinate sample submission.
Prepare Documentation: Start compiling the Device Master File, Plant Master File, Risk Management File, and QMS documentation. Our guides on Device Master File and Risk Management provide detailed instructions.
Plan for Notified Body Audit: Select a notified body from the CDSCO notified bodies list and schedule your audit.
Submit MD5 License Application: After successful testing and audit readiness, submit your manufacturing license application on the CDSCO portal.
Monitor Application Status: Track progress and respond promptly to any CDSCO or notified body queries.
Obtain License and Commence Manufacturing: Once granted, comply with all post-licensing obligations including periodic renewals and vigilance reporting.
Embarking on the CDSCO licensing process for your External Ring Fixation System with expert guidance ensures timely market access and adherence to regulatory standards. Contact us today to begin your journey toward successful CDSCO compliance.
