CDSCO License for Bone Wire
Medical Device Information
Intended Use
Intended to be used for bone stabilization in the hand and wrist.
Comprehensive Guide to CDSCO Licensing for Bone Wire (Class C Orthopaedic Implant)
Welcome to our expert overview for manufacturers and importers seeking CDSCO licensing for Bone Wire, a Class C orthopaedic implant used specifically for bone stabilization in the hand and wrist. With over 25 years of regulatory consulting experience and 500+ successful client licenses, we provide you with detailed, actionable insights for navigating India's stringent medical device regulatory framework.
Understanding Bone Wire and Regulatory Importance
Bone Wire plays a critical role in orthopaedic surgery by stabilizing small bones in the hand and wrist — a device that demands rigorous quality and safety validation due to its invasive nature. The Central Drugs Standard Control Organization (CDSCO) classifies Bone Wire as a Class C device, necessitating a higher level of regulatory scrutiny to ensure patient safety and device efficacy. Compliance with CDSCO is mandatory before marketing or manufacturing Bone Wire in India.
CDSCO Regulatory Framework for Bone Wire (Class C Device)
Bone Wire falls under the Orthopaedic Implants category notified under Notification 29/Misc/3/2018-DC(85) dated 06.06.2018. It is classified as a Class C device due to its moderate to high risk, involving direct implantation and critical physiological function support. This classification mandates obtaining an MD9 Manufacturing License granted by the Central Licensing Authority.
Risk Classification and Licensing Requirements
- Device: Bone Wire
- Risk Class: C (Moderate risk)
- Regulatory License: MD9 (Form MD7)
- Authority: Central Licensing Authority, CDSCO
- Notification Reference: 29/Misc/3/2018-DC(85)
MD9 Manufacturing License Process for Bone Wire
The MD9 license process is comprehensive and involves several key steps:
Test License (MD13 Application): Initiate the process by applying for a test license (Form MD13) which allows you to manufacture Bone Wire samples for testing. This step typically takes 1.5 to 2 months.
Product Testing: Conduct mandatory testing at CDSCO-approved government laboratories to confirm compliance with Indian standards and essential principles. Refer to the Testing Laboratories list for authorized facilities.
Document Preparation: Prepare detailed documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents. Our Device Master File guide offers practical steps for compiling these files.
License Application (Form MD7): Submit your MD9 application through the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors will audit your manufacturing facility and review documents to ensure compliance.
Query Resolution: Address any queries or observations raised during the audit or document review.
License Grant: Upon successful compliance, the MD9 license (Form MD9) is granted.
Documents Required for MD9 Manufacturing License
For Bone Wire, ensure the following documents are complete and accurate:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF)
- Plant Master File (PMF) – see our Plant Master File guide
- Essential Principles Compliance Checklist
- Risk Management File detailing hazard analysis and mitigation strategies (see Risk Management guidance)
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) compliant with Indian regulations
- Quality Management System Documents (e.g., ISO 13485:2016 certification)
Import License Process for Bone Wire (MD15 License)
If you plan to import Bone Wire, you will need to obtain an MD15 import license from CDSCO’s Central Licensing Authority. The process includes:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale License.
- Application submission using Form MD14 via the CDSCO MD Online Portal.
- Resolution of queries raised by CDSCO.
- License grant typically within 5 to 6 months.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| License Application (MD7) | 1 month |
| Audit and Query Resolution | 1 – 1.5 months |
| Total Approximate Time | 4 – 5 months |
Government Fees and Costs
- MD9 License Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product (Bone Wire counted as one product)
- Additional costs include testing fees at government labs and audit charges by notified bodies.
Common Challenges and Practical Solutions
- Delays in Testing: Ensure early booking with approved labs to avoid bottlenecks. Engage labs from the start.
- Incomplete Documentation: Use a checklist to verify all documents before submission. Our guides help streamline this.
- Audit Non-Compliance: Prepare your facility rigorously with pre-audit internal checks and staff training.
- Query Management: Respond promptly and comprehensively to CDSCO queries to avoid processing delays.
- Understanding Regulatory Updates: Stay current with notifications like 29/Misc/3/2018-DC(85) affecting Bone Wire.
Expert Consultation and Support
With our 25+ years of regulatory expertise and a track record of assisting 500+ companies, we offer tailored consulting services to simplify your CDSCO licensing journey. From document preparation to audit readiness and query resolution, our expert team ensures your Bone Wire license application is robust and compliant.
Getting Started with Your CDSCO License Application for Bone Wire
- Assess Your Readiness: Verify your manufacturing setup meets CDSCO requirements.
- Gather Documents: Use our detailed document guides to prepare your DMF, PMF, and QMS files.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with CDSCO-approved labs early.
- Prepare for Audit: Conduct internal audits and staff training.
- Submit MD9 Application: Once test license and testing are complete, apply using Form MD7.
- Engage with CDSCO: Respond promptly to audits and queries.
Starting this process with informed planning and expert support will vastly improve your chance of timely license approval for Bone Wire in India. Reach out to us to leverage our proven expertise and expedite your market entry.
For further detailed insights, refer to our comprehensive MD9 License Guide.
