CDSCO License for Intra Osseous Fixation Wire

Comprehensive Guide to CDSCO Licensing for Intra Osseous Fixation Wire (Class C Orthopaedic Implant)

As specialists with over 25 years of experience in medical device regulatory affairs, we have supported more than 500 companies in successfully obtaining CDSCO licenses across India. In this guide, we focus exclusively on the regulatory pathway for the Intra Osseous Fixation Wire—a Class C orthopaedic implant used for stabilization of fractured bony parts via direct fixation with surgical wires.

Understanding the regulatory nuances for this device type is critical for timely market entry, compliance, and sustained business success. We provide practical, detailed insights into the CDSCO licensing framework, timelines, costs, and documentation requirements based on the official notification 29/Misc/3/2018-DC(85) dated 06.06.2018.

CDSCO Regulatory Framework for Intra Osseous Fixation Wire

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory authority overseeing medical device registration and licensing in India. Orthopaedic implants, including your Intra Osseous Fixation Wire, are subject to stringent controls as they directly impact patient safety.

Under the Medical Device Rules (MDR) 2017, this device falls under Class C risk classification due to its invasive nature and critical role in fracture stabilization. This classification means the licensing process is handled by the Central Licensing Authority with oversight from CDSCO inspectors.

All applications must be submitted through the CDSCO MD Online Portal, ensuring transparency, traceability, and standardized processing.

Risk Classification and License Requirements for Class C Devices

Class C devices like the Intra Osseous Fixation Wire require an MD9 Manufacturing License (Application Form MD7). This is a higher-risk category than Class A/B, thus necessitating more rigorous evaluation, including:

• Test license acquisition (Form MD13)
• Mandatory product testing in government-approved laboratories
• Comprehensive documentation and technical file submission
• On-site audit by CDSCO inspectors

For importers, the corresponding license is the MD15 Import License (Form MD14), which involves document verification but does not require a test license.

For a detailed explanation of the classification system, you can refer to this Medical Device Classification guide.

Manufacturing License Process (MD9) for Intra Osseous Fixation Wire

1. Test License (Form MD13):

   • Apply for a test license allowing production of limited quantities for testing.
   • Processing time: Approximately 1.5 to 2 months.

2. Product Testing:

   • Conduct mandatory tests at CDSCO-approved labs. Find the list of testing laboratories here.
   • Typical tests include biocompatibility, mechanical strength, sterilization validation, and packaging integrity.

3. Document Preparation:

   • Prepare a robust technical dossier including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles compliance report.
   • Our Device Master File guide and Plant Master File guide can assist with this.

4. Application Submission:

   • Submit the MD9 application through the CDSCO MD Online Portal.

5. Audit:

   • CDSCO inspectors will conduct a thorough audit of the manufacturing facility, quality management systems (QMS), and compliance with MDR 2017.

6. Query Resolution:

   • Address any queries raised by the department or inspectors promptly.

7. License Grant:

   • Upon successful evaluation, the MD9 license is granted on Form MD9.

For a comprehensive step-by-step breakdown, consult our MD9 License Guide.

Manufacturing License Documents Required for Intra Osseous Fixation Wire

Successful MD9 license application requires meticulous compilation of the following documents:

• Company Constitution and incorporation certificates
• Proof of ownership or lease agreement of manufacturing premises
• Qualification and experience documents of technical staff
• Fire No Objection Certificate (Fire NOC)
• Pollution Control Board Clearance (Pollution NOC)
• Device Master File (DMF) detailing design, specifications, and manufacturing
• Plant Master File (PMF) describing manufacturing processes and quality systems
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File describing hazard analysis and mitigation strategies (see Risk Management resource)
• Test Reports from government-approved laboratories
• Product labels, Instructions for Use (IFU), and packaging details
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certification

Ensuring completeness and accuracy of these documents significantly reduces processing time and audit queries.

Import License Process (MD15) for Intra Osseous Fixation Wire

If you plan to import the Intra Osseous Fixation Wire rather than manufacture it locally, the MD15 import license is mandatory.

1. Document Preparation:

   • Assemble required documents including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), DMF, PMF, Wholesale License, and company constitution.

2. Application Submission:

   • File application on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution:

   • Promptly respond to any regulatory queries.

4. License Grant:

   • Upon review, CDSCO grants the MD15 import license.

No test license is required for import; however, the process generally takes longer—approximately 5-6 months.

Our Import License Guide provides further details.

Timeline and Processing Duration

For import licenses (MD15), the entire process may extend to 5-6 months.

Government Fees and Costs

Additional costs include product testing fees at notified laboratories and audit-related expenses.

Common Challenges and Solutions

• Delayed Test License Approvals: Prepare and submit complete documents upfront; engage with notified bodies early.
• Non-Compliance in Technical Documentation: Use expert consultants to ensure DMF, PMF, and Risk Management Files meet CDSCO standards.
• Audit Findings: Conduct internal mock audits; maintain robust QMS and traceability.
• Query Back-and-Forth: Assign dedicated regulatory personnel to promptly address CDSCO queries.

Check the list of notified bodies authorized for audits to select the most suitable partner.

Expert Consultation and Support

Given the complexity of Class C device licensing, partnering with experienced regulatory consultants can dramatically reduce approval timelines and avoid costly rejections. Our expertise spans document preparation, audit readiness, and direct liaison with CDSCO officials.

We recommend leveraging specialized guides such as our MD9 License Guide for best practices.

Getting Started with Your CDSCO License Application for Intra Osseous Fixation Wire

1. Assess your product classification and confirm Class C status.
2. Initiate the test license application (Form MD13) immediately to start production for testing.
3. Identify and coordinate with CDSCO-approved testing laboratories early.
4. Compile comprehensive documentation including DMF, PMF, Risk Management File, and QMS certificates.
5. Register and submit your application via the CDSCO MD Online Portal.
6. Prepare your manufacturing site for the CDSCO audit by conducting internal reviews.
7. Engage a regulatory expert to monitor progress and ensure prompt resolution of queries.

By following these practical steps, manufacturers and importers can confidently navigate the regulatory pathway for Intra Osseous Fixation Wires, accelerating access to the lucrative Indian orthopaedic implant market.

For personalized support tailored to your product and business needs, contact our regulatory team today—your trusted partner for CDSCO licensing success.