CDSCO License for Smooth or threaded metallic bone fixation fastener
Medical Device Information
Intended Use
It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Comprehensive Guide to CDSCO Licensing for Smooth or Threaded Metallic Bone Fixation Fasteners (Class C Orthopaedic Implants)
As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ companies, we understand the nuanced requirements for medical devices like Smooth or threaded metallic bone fixation fasteners. These devices, classified as Class C under the CDSCO framework, are critical orthopaedic implants used for bone fracture fixation, reconstruction, and skeletal traction. Navigating the regulatory landscape efficiently ensures timely market entry and compliance with India’s stringent quality standards.
CDSCO Regulatory Framework for Smooth or Threaded Metallic Bone Fixation Fasteners
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Orthopaedic implants such as metallic bone fixation fasteners fall under Class C due to their invasive nature and significant potential risk to the patient if misused or defective. This classification mandates a rigorous approval process through the central licensing authority.
The regulatory framework includes:
- Risk-based classification
- Mandatory testing in government-approved laboratories
- Submission of detailed technical documentation
- On-site audits by CDSCO inspectors
- Compliance with Essential Principles of Safety and Performance
Risk Classification and License Requirements for Class C Devices
According to the CDSCO classification, Class C devices like your metallic bone fixation fastener require an MD9 manufacturing license. This license is granted by the Central Licensing Authority, reflecting the higher risk associated with these implants. The MD9 license process involves more stringent scrutiny compared to lower-class devices, including:
- Pre-approval of Test License (MD13)
- Mandatory testing in notified laboratories
- Compliance with ISO 13485:2016 QMS standards
- On-site audit and technical evaluation
For importers, an MD15 import license is necessary, but manufacturers must focus on MD9 for local production.
Manufacturing License Process for MD9 (Class C Medical Devices)
The entire MD9 licensing process typically spans 4 to 5 months and involves several critical steps:
Test License Application (Form MD13): Before manufacturing, companies must apply for a test license to produce samples for testing. This takes approximately 1.5 to 2 months.
Product Testing: Samples are sent to government-approved testing laboratories to verify conformity with regulatory standards. Refer to the list of testing laboratories for authorized facilities.
Technical Documentation Preparation: This includes Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documentation.
Application for Manufacturing License (Form MD7): Post successful testing, the manufacturer submits an application for the MD9 license.
On-site Audit: CDSCO inspectors conduct a comprehensive audit of the manufacturing facility and quality systems.
Query Resolution: Any queries raised by the department or auditors must be promptly addressed.
Grant of License (Form MD9): Upon satisfactory compliance, the manufacturing license is issued.
For detailed procedural guidance, our MD9 License Guide offers practical insights.
Manufacturing License Documents Required for Smooth or Threaded Metallic Bone Fixation Fasteners
To ensure a smooth application process, gather the following key documents:
- Company Constitution: Incorporation certificate, memorandum, and articles of association.
- Proof of Premises Ownership/Lease: Valid property documents.
- Technical Staff Credentials: CVs and qualifications of key technical personnel.
- Fire and Pollution NOCs: Safety clearances from local authorities.
- Device Master File: Detailed design, manufacturing process, and specifications. Our comprehensive Device Master File guide can assist.
- Plant Master File: Details about the manufacturing facility and quality control processes, with tips in our Plant Master File Guide.
- Essential Principles Checklist: Demonstration of compliance with safety and performance standards.
- Risk Management File: Risk analysis and mitigation strategies per ISO 14971. Learn more about Risk Management.
- Test Reports: From CDSCO-approved laboratories.
- Labels and Instructions for Use (IFU): Clear labeling and user instructions.
- Quality Management System Documents: ISO 13485:2016 certification and related quality processes.
Import License Process (MD15) for Orthopaedic Implants
If you plan to import Smooth or threaded metallic bone fixation fasteners, an MD15 import license is mandatory. The process involves:
- Compiling robust technical and quality documents, including manufacturing license from the country of origin, free sale certificate, CE certificate, and ISO 13485:2016.
- Submitting the application on Form MD14 via the CDSCO MD Online Portal.
- Responding to departmental queries within stipulated timelines.
- Awaiting grant of import license (Form MD15), typically within 5 to 6 months.
Import License Documents Required
- Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license of the Indian importer
- Company constitution documents
Timeline and Processing Duration
| Process Step | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Application for MD9 License | Submission to grant: 2 - 3 months (including audit and queries) |
| Total for MD9 License | 4 - 5 months |
| Import License (MD15) Process | 5 - 6 months |
Government Fees and Costs
- MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product.
- Test License (MD13): Separate fees apply, generally included in consultancy.
- Import License (MD15): Fees vary by class; for Class C & D devices, Rs 3,000 per site + Rs 1,500 per product.
Note that these fees are payable through the online portal during application submission.
Common Challenges and Solutions
Challenge: Delays in test license approval and product testing.
Solution: Initiate test license application early and coordinate closely with notified testing labs. Our experience shows pre-submission audits and readiness checks cut down delays significantly.
Challenge: Non-compliance in documentation leading to queries.
Solution: Follow a checklist-based approach for documents. Use templates from our Device Master File guide and Plant Master File Guide to ensure completeness.
Challenge: Audit non-conformities related to quality systems.
Solution: Implement robust QMS per ISO 13485:2016 and conduct internal audits beforehand. We recommend risk management integration per ISO 14971.
Expert Consultation and Support
With decades of hands-on experience, we provide end-to-end support:
- Regulatory strategy tailored to your device
- Preparation and review of all technical dossiers
- Coordination with notified bodies and CDSCO inspectors
- Post-approval compliance and vigilance support
Our proactive approach has helped over 500 manufacturers and importers successfully navigate the complex CDSCO processes with minimal delays.
Getting Started with Your CDSCO License Application
Assess your device classification: Confirm your device is Class C via the Medical Device Classification guide.
Prepare essential documents: Use our Device and Plant Master File guides to compile comprehensive dossiers.
Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal to begin the testing phase.
Engage a notified body: Check the list of notified bodies for audit and certification requirements.
Schedule product testing: Coordinate with government-approved labs early to expedite the testing process.
Plan for audit and inspection: Ensure your manufacturing site complies with all regulatory and quality standards.
Submit MD9 License Application: Once testing and documentation are finalized, apply via the CDSCO portal.
Embarking on the CDSCO licensing journey for your Smooth or threaded metallic bone fixation fastener requires meticulous planning and expert guidance. We are here to ensure your regulatory pathway is smooth, compliant, and timely, enabling successful entry into the Indian orthopaedic implant market.
