CDSCO License for Flexible bone nail, sterile
Medical Device Information
Intended Use
A sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fractures and some metaphyseal fractures of paediatrics and small- statured/normal adults to provide temporary stabilization of the bone segments/fragments until bone consolidation has been achieved. It is intended to splint the cortices and maintain elastic energy to continually brace against rotational/angular forces of the muscles. This is a single-use device.
Introduction to Flexible Bone Nail (Sterile) and Regulatory Importance
The Flexible Bone Nail is a critical Class C medical device designed for pediatric and adult orthopedic fracture fixation. As a sterile, flexible metallic rod intended for intramedullary insertion, it plays an essential role in stabilizing long bone fractures while allowing elastic bracing against muscle forces. Due to its invasive nature and direct contact with bone tissues, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is mandatory to ensure patient safety and device efficacy in India.
With over 25 years of experience guiding more than 500 manufacturers and importers, we understand the complexities involved in obtaining the CDSCO license for devices like the Flexible Bone Nail. This comprehensive guide covers the regulatory framework, risk classification, licensing pathways, practical timelines, fees, and documentation requirements tailored specifically for your device.
CDSCO Regulatory Framework for Flexible Bone Nail (Class C Medical Device)
The CDSCO governs the import and manufacture of all medical devices in India under the Medical Devices Rules, 2017. For Class C devices such as the Flexible Bone Nail, the regulatory process is centralized and stringent due to the moderate to high risk associated with implantable orthopedic devices. CDSCO mandates compliance with quality management systems (ISO 13485), essential principles of safety and performance, and requires detailed technical documentation.
Manufacturers must obtain an MD9 manufacturing license issued by the Central Licensing Authority, while importers require an MD15 import license. Both processes involve rigorous review, testing, and inspections.
Risk Classification and License Requirements for Flexible Bone Nail
The Flexible Bone Nail falls under:
- Risk Class: C (Moderate to high risk, implantable)
- License Type: MD9 for manufacturing (Central Authority)
- Import License: MD15 (Central Authority)
Class C devices require a more detailed technical dossier, clinical evaluation reports, and a full audit by CDSCO inspectors. This classification ensures higher patient safety standards, particularly important for invasive orthopedic implants.
Manufacturing License Process (MD9) for Flexible Bone Nail
The MD9 license process involves several critical stages:
Test License (Form MD13): You must first obtain a test license for clinical investigations and sample testing. This preliminary step takes approximately 1.5 to 2 months.
Product Testing: Samples must be tested in CDSCO-approved laboratories to verify compliance with Indian standards. Refer to the CDSCO Testing Laboratories list for approved options.
Document Preparation: Prepare comprehensive documentation including the Device Master File, Plant Master File, risk management file, essential principles checklist, and quality management system documents.
Application Submission (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal along with required fees.
Audit by CDSCO Inspectors: Following document acceptance, CDSCO will conduct an on-site audit of your manufacturing facility to verify compliance.
Query Resolution: Address any queries raised by the CDSCO or auditors promptly.
Grant of License (Form MD9): Upon satisfying all conditions, the MD9 manufacturing license is granted.
The entire process typically takes 4 to 5 months.
Manufacturing License Documents Required for MD9
For the Flexible Bone Nail MD9 application, the documentation checklist includes:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (covering design, specifications, and manufacturing process) Learn more
- Plant Master File describing manufacturing facilities and quality systems Guide here
- Essential Principles Compliance Checklist
- Risk Management File detailing risk assessments and mitigation strategies Risk Management Insights
- Test Reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System Documentation (ISO 13485:2016 compliance)
Ensuring each document is precise and complete greatly expedites the licensing process.
Import License Process (MD15) for Flexible Bone Nail
If you are importing the Flexible Bone Nail into India, an MD15 import license issued by CDSCO’s Central Licensing Authority is mandatory.
The steps include:
Document Compilation: Prepare your dossier including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, Device Master File, Plant Master File, wholesale license, and company incorporation documents.
Application Submission (Form MD14): Submit your import license application via the CDSCO MD Online Portal.
Query Resolution: Respond to any clarifications or additional information requests.
Grant of License (Form MD15): Upon satisfactory review, CDSCO will issue the import license.
The import license process takes approximately 5 to 6 months.
Import License Documents Required for MD15
Essential documents for the Flexible Bone Nail import license include:
- Valid Manufacturing License from the Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or Equivalent
- Device Master File
- Plant Master File
- Wholesale Drug License
- Company Constitution Documents
Thorough preparation ensures smoother approval timelines.
Timeline and Processing Duration Summary
| License Type | Process Duration |
|---|---|
| MD13 Test License | 1.5 - 2 months |
| MD9 Manufacturing License | 4 - 5 months (including testing and audit) |
| MD15 Import License | 5 - 6 months |
Plan your market entry accordingly to accommodate these timeframes.
Government Fees and Costs for Flexible Bone Nail Licensing
MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
MD15 Import License Fees: (class C devices)
- Site Fee: $3,000 (approx ₹2,40,000)
- Per Product Fee: $1,500 (approx ₹1,20,000)
These fees are payable online during application submission via the CDSCO portal.
Common Challenges and Solutions in CDSCO Licensing for Flexible Bone Nail
Incomplete Documentation: Missing detailed Device or Plant Master Files can delay audits. We recommend following our Device Master File guide to avoid gaps.
Testing Delays: Selecting inappropriate or non-approved labs can extend testing times. Always use CDSCO-approved testing centers.
Audit Non-Compliance: Lack of preparedness for CDSCO inspections is a common pain point. Conduct internal audits and gap analyses beforehand.
Query Management: Delayed responses to CDSCO queries can stall approvals. Assign dedicated regulatory personnel for timely communication.
Expert Consultation and Support for Your Flexible Bone Nail License
With decades of experience, our expert consultants support you through every step—from initial classification and dossier preparation to audit readiness and post-approval compliance. Our tailored strategies minimize errors, reduce processing times, and ensure regulatory compliance.
Getting Started with Your CDSCO License Application for Flexible Bone Nail
Confirm Device Classification: Double-check your device’s Class C status using comprehensive classification tools like Medical Device Classification.
Gather Documentation: Begin compiling your Device Master File, Plant Master File, risk management documents, and quality system certifications.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to start the testing phase.
Engage a Notified Body: Identify and coordinate with a notified body for mandatory audits. See the list of notified bodies.
Schedule Testing: Send product samples to CDSCO-approved labs early to avoid bottlenecks.
Prepare for Audit: Conduct internal readiness assessments before the CDSCO inspection.
Submit Application: File your MD9 license application upon successful testing and audit preparations.
By following these practical steps with expert guidance, manufacturers and importers can confidently navigate the CDSCO licensing journey for the Flexible Bone Nail, ensuring timely market access and compliance.
For personalized assistance and to discuss your specific project requirements, contact our regulatory consulting team today.
