CDSCO License for Flexible bone nail, non-sterile
Medical Device Information
Intended Use
A non-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 intended to be sterilized prior to use.
Introduction to Flexible Bone Nail (Non-Sterile) and Its Regulatory Importance
Flexible bone nails are critical orthopedic implants used primarily for pediatric and small-stature adult fracture fixation. Designed as non-sterile, flexible bending rods inserted into the intramedullary canal, these devices provide temporary stabilization to fractured long bones while maintaining elastic bracing against muscle forces. Given their invasive nature and direct contact with bone tissue, flexible bone nails are classified as Class C medical devices under the CDSCO regulatory framework. Strict compliance with CDSCO requirements ensures patient safety, device efficacy, and smooth market entry in India.
With over 25 years of experience helping 500+ companies obtain CDSCO licenses, we understand the unique challenges manufacturers and importers face when navigating the regulatory landscape for orthopedic implants like flexible bone nails. This guide shares practical insights, timelines, costs, and documentation specifics tailored for this device type and risk class.
CDSCO Regulatory Framework for Flexible Bone Nails
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules 2017. Flexible bone nails fall under Class C due to moderate to high risk, requiring a centralized manufacturing license (MD9) or import license (MD15) from CDSCO's Central Licensing Authority.
Manufacturers must follow a structured process involving product testing, quality management system implementation, and factory audits. Importers, meanwhile, must ensure foreign-manufactured devices meet Indian regulatory requirements, including valid manufacturing licenses and certifications.
Risk Classification and License Requirements for Flexible Bone Nail
- Risk Class: C (moderate to high risk)
- License for Manufacturing: MD9 License (Form MD7) issued by CDSCO Central Licensing Authority
- License for Import: MD15 License (Form MD14) issued by CDSCO Central Licensing Authority
This classification triggers rigorous technical documentation, testing, and audit requirements compared to Class A or B devices.
Manufacturing License Process for Flexible Bone Nail (MD9 License)
The manufacturing license for Class C devices (MD9) is a multi-step process managed by CDSCO's Central Licensing Authority:
Test License (Form MD13): Before full license application, manufacturers must obtain a test license to legally manufacture and test the device. This phase typically takes 1.5 to 2 months.
Product Testing: Samples must be tested in CDSCO-approved government laboratories to verify safety and performance. Refer to the Testing Laboratories list for approved labs.
Document Preparation: Compile all required documentation including Device Master File, Plant Master File, risk management files, and quality management system documents.
Application Submission: Submit the manufacturing license application on Form MD7 through the CDSCO MD Online Portal.
Audit and Inspection: CDSCO inspectors conduct factory audits to verify compliance with Good Manufacturing Practices (GMP) and quality system standards.
Query Resolution: Address any deficiencies or clarifications raised by CDSCO during the evaluation and audit.
Grant of License: Upon satisfactory review, CDSCO issues the MD9 manufacturing license.
For an in-depth understanding, our MD9 License Guide details each step.
Manufacturing License Documents Required for Flexible Bone Nail
The comprehensive dossier for MD9 licensing includes:
- Company Constitution and Registration Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF) covering design, specifications, and manufacturing process. See our Device Master File Guide
- Plant Master File (PMF) describing facility layout, equipment, and quality controls. See our Plant Master File Guide
- Essential Principles Checklist confirming compliance with safety and performance standards
- Risk Management File demonstrating hazard analysis and mitigation measures. Learn more about Risk Management
- Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, typically ISO 13485:2016 compliance evidence
Ensuring accuracy and completeness of these documents significantly reduces processing delays.
Import License Process for Flexible Bone Nail (MD15 License)
Importers of flexible bone nails must secure an MD15 import license granted by the CDSCO Central Licensing Authority. The process involves:
Document Preparation: Gather necessary documentation including valid foreign manufacturing license (MD9 equivalent), Free Sale Certificate, ISO 13485 certification, CE Certificate, and detailed product dossiers.
Application Submission: File application on Form MD14 through the CDSCO MD Online Portal.
Evaluation and Queries: CDSCO reviews submission and may raise queries.
Grant of License: Upon satisfactory evaluation, the MD15 import license is issued.
Note that unlike manufacturing licenses, no test license is required for import.
Our detailed Import License Guide provides further insight.
Import License Documents Required for Flexible Bone Nail
Key documents include:
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or Equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution and Registration Proof
Ensuring foreign manufacturers comply with Indian standards expedites approval.
Timeline and Processing Duration
MD9 Manufacturing License: Approximately 4 to 5 months total
- Test license (MD13): 1.5 to 2 months
- Product testing: 1 to 1.5 months
- Document preparation & submission: 2 to 3 weeks
- Audit and query resolution: 1 to 1.5 months
MD15 Import License: Approximately 5 to 6 months
- Document preparation and submission: 1 month
- Evaluation and query resolution: 3 to 5 months
Timely responses to CDSCO queries and pre-prepared documentation can shorten these timelines.
Government Fees and Costs
MD9 License Fees:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
MD15 Import License Fees:
- Class C Devices: ₹3,000 per site
- Per Product Fee: ₹1,500
Additional costs include product testing fees at government labs and fees for audits by CDSCO or notified bodies.
Common Challenges and Solutions
Incomplete Documentation: Many delays arise from missing or inconsistent documents. We recommend preparing checklists aligned with CDSCO requirements.
Testing Delays: Government laboratories have limited capacity. Early sample submission and choosing labs wisely can mitigate delays.
Audit Non-Compliance: Manufacturers often struggle with QMS or GMP compliance. Conducting pre-audit internal assessments can improve success.
Query Resolution: Slow or inadequate responses to CDSCO queries extend timelines. Establishing a dedicated regulatory liaison expedites communication.
Understanding Classification: Misclassification leads to wrong license applications. Refer to our Medical Device Classification guide to confirm your device class.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like flexible bone nails can be complex. Our seasoned regulatory consultants have enabled over 500 companies to achieve timely approvals. We offer tailored support from classification advice, document preparation, application submission, to audit readiness.
Partnering with experts ensures adherence to regulations, minimizes rejections, and accelerates market entry.
Getting Started with Your CDSCO License Application
Confirm Device Classification: Verify your flexible bone nail is Class C under CDSCO rules.
Engage Testing Laboratories: Identify and contact government-approved labs early for sample testing.
Prepare Documentation: Begin compiling Device Master File, Plant Master File, risk management, and QMS documents using our detailed guides.
File Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to initiate manufacturing testing.
Plan for Audit: Select a notified body for audit if required; consult the List of Notified Bodies for options.
Schedule Regular Reviews: Monitor application status and be prompt in addressing queries.
By following these actionable steps and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for flexible bone nails and successfully establish their presence in the Indian medical device market.
