CDSCO License for Craniofacial bone screw, bioabsorbable
Medical Device Information
Intended Use
A small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.
Comprehensive Guide to CDSCO Licensing for Craniofacial Bone Screw, Bioabsorbable (Class D Medical Device)
Introduction: Understanding the Craniofacial Bone Screw and Its Regulatory Significance
The bioabsorbable craniofacial bone screw is a critical Class D medical device used extensively in pediatric and neonatal craniofacial surgeries. Designed as a sterile, threaded rod capable of self-drilling or self-tapping, its primary function is to stabilize fractures in the maxillofacial region by securing plates or providing direct interfragmentary fixation. The screw's bioabsorbable nature allows it to gradually degrade within the body, eliminating the need for removal surgeries—a significant clinical advantage in pediatric reconstructive procedures.
Given its invasive use and the vulnerable patient population, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is rigorous. Manufacturers and importers must navigate a detailed approval process to ensure patient safety and compliance with Indian medical device regulations.
CDSCO Regulatory Framework for Bioabsorbable Craniofacial Bone Screws
As a Class D device, the bioabsorbable craniofacial bone screw falls under the highest risk category according to the CDSCO's medical device classification system. This classification mandates a stringent regulatory pathway primarily governed by the Central Licensing Authority.
Under the Medical Device Rules (MDR) 2017, Class D devices require an MD9 manufacturing license for domestic manufacture and an MD15 import license for foreign manufacturers or importers. Compliance with quality management systems like ISO 13485:2016, thorough documentation, product testing, and on-site audits are compulsory.
Risk Classification and License Requirements for Class D Devices
- Risk Class: D (Highest risk)
- License Type for Manufacturing: MD9 License (Form MD7)
- License Type for Import: MD15 License (Form MD14)
- Regulatory Authority: Central Licensing Authority under CDSCO
The MD9 license process involves multiple stages including test licensing, product testing at government-approved laboratories, comprehensive documentation submission, and regulatory audits.
Manufacturing License Process for MD9 License (Form MD7)
At our firm, with over 25 years of experience assisting 500+ companies, we have refined the MD9 license acquisition process into clear, actionable steps:
Test License Application (Form MD13): Before applying for the MD9 license, manufacturers must secure a test license, which typically takes 1.5 to 2 months to process. This license permits manufacturing for product testing purposes.
Product Testing: The craniofacial bone screw must undergo rigorous testing in CDSCO-approved laboratories. Testing includes biocompatibility, mechanical integrity, sterilization validation, and degradation profile assessment relevant to bioabsorbable materials. Refer to the list of testing laboratories for accredited facilities.
Document Preparation: Concurrently, detailed documentation must be prepared, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documents.
License Application Submission: Submit the MD9 license application on the CDSCO MD Online Portal using Form MD7.
Regulatory Audit: CDSCO inspectors conduct an on-site audit of manufacturing premises and quality systems.
Query Resolution: Any queries raised by CDSCO or auditors must be addressed promptly.
License Grant: Upon satisfactory review and audit, the MD9 license is granted on Form MD9.
For a detailed walkthrough, our clients benefit from the MD9 License Guide.
Manufacturing License Documents Required for Craniofacial Bone Screw (Class D)
The following documents are essential:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire Safety No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
- Plant Master File outlining manufacturing infrastructure and quality controls (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with Indian medical device regulations
- Risk Management File per ISO 14971 standards (Risk Management Guidance)
- Product Test Reports from government-approved labs
- Labeling and Instructions for Use (IFU) compliant with CDSCO requirements
- Quality Management System Documents, including ISO 13485:2016 certification
Import License Process (MD15) for Craniofacial Bone Screw
For importers of bioabsorbable craniofacial bone screws, the MD15 license application involves these steps:
Document Compilation: Gather all necessary documents including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, and Plant Master File.
Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.
Query Resolution: Address any queries raised by CDSCO promptly.
License Issuance: Upon approval, the MD15 import license is granted.
Unlike the manufacturing MD9 license, a test license is not required for import applications. The process typically spans 5-6 months.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Marking Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale Drug License
- Company Constitution Documents
Our detailed Import License Guide offers step-by-step assistance.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation Preparation | Concurrent with above |
| Application Review & Audit | 1.5 - 2 months |
| Query Resolution | Variable (usually 2 - 4 weeks) |
| Total for MD9 License | Approximately 4 - 5 months |
| Total for MD15 License | Approximately 5 - 6 months |
Government Fees and Costs
MD9 Manufacturing License:
- Application Fee: INR 50,000
- Per Product Fee: INR 1,000
MD15 Import License:
- Site Fee: USD 3,000
- Per Product Fee: USD 1,500
Additional costs include testing fees payable to approved laboratories and audit fees charged by notified bodies.
Common Challenges and Solutions
Challenge 1: Delays in product testing due to complex bioabsorbable material evaluation.
Solution: Engage early with CDSCO-approved laboratories and provide detailed product specifications to expedite testing.
Challenge 2: Comprehensive documentation preparation, especially for Device Master File and Risk Management.
Solution: Utilize expert consultancy services to develop these files in compliance with CDSCO and ISO standards.
Challenge 3: Audit non-compliance related to QMS and premises.
Solution: Conduct pre-audit internal assessments and training to ensure readiness.
Challenge 4: Query resolution delays due to incomplete or unclear responses.
Solution: Maintain clear communication with CDSCO and provide thorough, well-documented replies.
Expert Consultation and Support
With decades of experience and over 500 successful CDSCO license approvals for high-risk devices, we offer end-to-end support:
- Regulatory strategy planning tailored to Class D devices
- Documentation preparation including DMF and Risk Management Files
- Coordination with notified bodies and testing labs
- Training and audit preparedness
- Timely response management for CDSCO queries
Our expertise minimizes approval timelines and mitigates risks of non-compliance.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device as Class D via the Medical Device Classification tool.
Prepare for Test License: Initiate the test license (Form MD13) application on the CDSCO MD Online Portal.
Engage Testing Labs: Select and coordinate with government-approved testing laboratories early.
Compile Documentation: Begin assembling your Device and Plant Master Files, Risk Management, and QMS documentation.
Plan for Audit: Schedule internal audits and readiness checks ahead of the CDSCO inspection.
Submit Application: Apply for the MD9 manufacturing license (Form MD7) through the online portal upon successful testing and document readiness.
Prepare for Queries: Establish a dedicated team to manage and promptly respond to CDSCO queries during the review.
Starting early and working with seasoned regulatory consultants will streamline your path to market entry in India for this specialized, high-risk pediatric device.
For more detailed guidance or personalized consulting, please contact our team—your trusted partner in navigating CDSCO medical device regulatory compliance.
