CDSCO License for Cortical Fixation Implant / rigidloop Adjustable Cortical Fixation System
Medical Device Information
Intended Use
Cortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments.
Comprehensive Guide to CDSCO Licensing for Cortical Fixation Implant (Rigidloop Adjustable Cortical Fixation System)
The Cortical Fixation Implant, specifically the Rigidloop Adjustable Cortical Fixation System, is a precision-engineered titanium device used for tendon and ligament repair in orthopaedics. As a Class C medical device under the CDSCO regulatory framework, it demands stringent regulatory compliance to ensure safety, efficacy, and quality before entering the Indian market.
Having supported over 500 manufacturers and importers in navigating CDSCO licensing, we understand the nuances of bringing complex orthopaedic implants like the Cortical Fixation System to India. This detailed guide covers everything from risk classification to the practical steps of securing your CDSCO license.
CDSCO Regulatory Framework for Cortical Fixation Implants
The Central Drugs Standard Control Organization (CDSCO) regulates the import and manufacture of medical devices in India. Since the 2018 notification (29/Misc/3/2018-DC(85)), orthopaedic implants such as the Cortical Fixation Implant fall under the purview of CDSCO as Class C devices due to their moderate to high risk in terms of patient safety.
Class C devices require licenses issued by the Central Licensing Authority with rigorous evaluation involving product testing, quality system auditing, and technical documentation review.
Manufacturers must apply for the MD9 license (manufacturing license for Class C/D devices), while importers need to secure an MD15 import license.
Risk Classification and License Requirements for Cortical Fixation System
- Risk Class: C (Moderate to high risk)
- License Type:
- Manufacturing: MD9 License (Application Form MD7)
- Import: MD15 License (Application Form MD14)
- Regulatory Authority: Central Licensing Authority (CDSCO HQ)
To understand device classification better, manufacturers can refer to the Medical Device Classification Guide.
Manufacturing License Process for MD9 (Class C Device)
The MD9 license process is comprehensive, ensuring the highest quality and safety standards for your Cortical Fixation Implant.
Stepwise Process:
Test License Application (Form MD13): Initiate with applying for a test license, which permits limited manufacture for testing purposes. This phase typically takes 1.5 to 2 months.
Product Testing: Samples of your implant must be tested at CDSCO-approved laboratories. Refer to the List of Testing Laboratories to select an appropriate facility.
Documentation Preparation: Prepare exhaustive technical documents including Device Master File, Plant Master File, Risk Management File, QMS documents, and Essential Principles Checklist.
Manufacturing License Application (Form MD7): Submit your application for the MD9 license on the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors conduct audits of your manufacturing site, reviewing compliance with GMP, QMS, and regulatory standards.
Query Resolution: Address any queries or observations raised by the CDSCO during the audit or documentation review.
Grant of License: Upon satisfactory compliance, the MD9 license is granted.
Total Timeline:
Approximately 4 to 5 months from test license application to final MD9 license grant.
Manufacturing License Documents Required for MD9
- Company Constitution (e.g., MOA, AOA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, manufacturing, and quality control processes (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing infrastructure (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with Indian standards
- Risk Management File highlighting hazard analysis and mitigation strategies (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process for MD15
For companies intending to import the Cortical Fixation Implant into India, an MD15 import license is mandatory.
Stepwise Process:
Document Preparation: Compile all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, and Plant Master File.
Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
Query Resolution: Respond promptly to any queries raised by CDSCO officers.
Grant of Import License (MD15): License is issued upon successful review.
Total Timeline:
Approximately 5 to 6 months from application to license grant.
Import License Documents Required for MD15
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or Equivalent Regulatory Approvals
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration Summary
| License Type | Timeline | Key Milestones |
|---|---|---|
| MD9 Manufacturing | 4-5 months | Test license (1.5-2 months), testing, audit |
| MD15 Import | 5-6 months | Document review, query resolution |
Our real-world experience shows that proactive preparation and timely responses to CDSCO queries can significantly smoothen these timelines.
Government Fees and Costs
MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
MD15 Import License:
- Class C Devices: ₹3,000 per site + ₹1,500 per product
Additional costs to consider include product testing fees at approved laboratories and audit charges if applicable.
Common Challenges and Solutions
Challenge 1: Delays due to incomplete documentation
- Solution: Meticulously prepare your Device Master File and Plant Master File. Use expert templates and checklists to avoid omissions.
Challenge 2: Non-compliance during audit
- Solution: Conduct internal audits prior to CDSCO inspection to ensure compliance with GMP and QMS requirements.
Challenge 3: Product testing failures or delays
- Solution: Select reliable CDSCO-approved labs early and perform pre-testing to identify potential issues.
Challenge 4: Slow query resolution
- Solution: Assign dedicated regulatory personnel to monitor and respond promptly to CDSCO communications.
Expert Consultation and Support
Navigating the CDSCO licensing landscape for Class C devices like the Cortical Fixation Implant is complex. With over 25 years of regulatory consulting expertise and 500+ successful client licenses, we offer tailored support to accelerate your approval process.
Our services include:
- End-to-end application preparation and submission
- Comprehensive document drafting for DMF and PMF
- Coordination with CDSCO and notified bodies
- Pre-audit readiness assessments
- Handling product testing and technical queries
Contact us to leverage our deep domain expertise and ensure your product reaches Indian patients on time.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your product’s Class C status using the CDSCO classification guidelines.
Initiate Test License Application: Apply for Form MD13 via the CDSCO MD Online Portal to begin manufacturing for testing.
Engage Testing Labs: Schedule product testing with CDSCO-approved laboratories listed here.
Prepare Regulatory Documents: Develop your Device Master File and Plant Master File with attention to the specifics of your implant.
Plan for Audit: Identify notified bodies and prepare for CDSCO inspection. You may review the notified bodies list for reference.
Submit MD9 License Application: Once testing and documentation are in place, submit Form MD7.
Monitor Progress: Maintain close communication with CDSCO and respond swiftly to any queries.
Embarking on this regulatory journey with proper planning and expert guidance can make the difference between delays and success. Reach out to our team to get personalized assistance tailored to your Cortical Fixation Implant licensing needs.
By following this structured approach, your Cortical Fixation Implant will be well-positioned to meet Indian regulatory standards, ensuring patient safety and market access.
For detailed support, consult our MD9 License Guide and Import License Guide to deepen your understanding and prepare effectively.
