CDSCO License for Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
Medical Device Information
Intended Use
Intended to be implanted to replace part of a knee joint
Comprehensive Guide to CDSCO Licensing for Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis
Knee joint femorotibial metal/polymer non-constrained cemented prostheses are critical orthopaedic implants designed to replace damaged parts of the knee joint. Given their implantable nature and direct impact on patient health, these devices fall under Class C risk classification in India’s regulatory framework, necessitating stringent compliance with the Central Drugs Standard Control Organization (CDSCO) regulations.
With over 25 years of experience assisting more than 500 medical device manufacturers and importers, we understand the complexities involved in securing CDSCO licenses. In this detailed guide, we focus on the regulatory pathway for your device type — a Class C orthopaedic implant — ensuring you have actionable insights to fast-track your entry into the Indian market.
CDSCO Regulatory Framework for Orthopaedic Implants
Orthopaedic implants like the knee joint femorotibial prosthesis are regulated under the Medical Device Rules, 2017, notified under the Drugs and Cosmetics Act. The notification 29/Misc/3/2017-DC (292), dated 06.06.2018, formally classifies this device as Class C due to its implantable, life-sustaining nature.
The CDSCO mandates licensing through a centralized system for Class C devices, ensuring robust evaluation of safety, efficacy, and manufacturing quality.
Risk Classification and License Requirements for Knee Joint Prosthesis
As a Class C device, the knee joint femorotibial prosthesis requires an MD9 manufacturing license. This license is issued by the Central Licensing Authority and involves a thorough process including test licensing, product testing, document scrutiny, and factory audit.
You can review the Medical Device Classification to confirm your device’s risk class and associated requirements.
Manufacturing License Process (MD9) for Class C Devices
The MD9 license process typically spans 4 to 5 months and involves several critical steps:
Test License Application (Form MD13): Apply for a test license to legally manufacture the device for testing purposes. This stage usually takes 1.5 to 2 months.
Product Testing: Conduct mandatory testing at government-approved labs to validate safety and performance. Refer to the list of testing laboratories for recognized facilities.
Document Preparation: Compile comprehensive dossiers including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal with all required documents.
Audit by CDSCO Inspectors: Prepare for a meticulous factory inspection assessing compliance with Good Manufacturing Practices (GMP) and QMS standards.
Query Resolution: Promptly address any queries raised by the CDSCO or inspectors to avoid delays.
Grant of License (Form MD9): Upon successful completion, the license is granted allowing commercial manufacture.
Manufacturing License Documents Required
For your knee joint prosthesis, ensure the following documents are meticulously prepared:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Documents of Technical and Managerial Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File detailing specifications and manufacturing process (Device Master File Guide)
- Plant Master File describing manufacturing facilities and quality systems (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with regulatory standards
- Risk Management File aligned with ISO 14971 principles (Risk Management)
- Test Reports from government-approved labs
- Product Labels and Instructions For Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Class C Devices
If you are an importer of this device, the MD15 import license issued by the Central Licensing Authority is mandatory. The process typically takes 5 to 6 months and involves:
- Preparation of documents including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016 and CE Certificates
- Submission of application through the CDSCO MD Online Portal
- Resolution of any departmental queries
- License grant on Form MD15
Import License Documents Required
- Valid Manufacturing License of the product
- Free Sale Certificate issued by the regulatory authority of the country of origin
- ISO 13485:2016 certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | Concurrent or 1 month |
| MD9 License Application | 4 – 5 months total |
| Overall Manufacturing License | Approximately 4 – 5 months (including test license and audit) |
| Import License (MD15) | 5 – 6 months |
Government Fees and Costs
- MD9 Manufacturing License: Rs. 50,000 per application plus Rs. 1,000 per product.
- Test License (MD13): Included in overall costs; minor fees apply.
- Import License (MD15): For Class C devices, Rs. 3,000 per site and Rs. 1,500 per product.
Budgeting for testing, notified body audits, and documentation preparation costs is crucial. Check the list of notified bodies to engage an accredited auditor.
Common Challenges and Solutions
- Delayed Test Reports: Partner with government-approved labs early to avoid bottlenecks.
- Incomplete Documentation: Use detailed checklists for Device and Plant Master Files to ensure completeness.
- Audit Non-Compliance: Conduct pre-audit internal reviews emphasizing GMP compliance.
- Query Resolution Delays: Maintain a dedicated regulatory liaison to respond swiftly.
Expert Consultation and Support
Navigating the CDSCO licensing landscape requires expertise. Our 25+ years of experience means we can:
- Assist with document preparation and gap analysis
- Coordinate product testing and auditor engagement
- Provide pre-audit readiness assessments
- Manage application submissions and follow-ups on the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class C status using official guidance.
- Initiate Test License Application: Submit Form MD13 via the CDSCO portal.
- Engage Testing Laboratory: Schedule product testing early to avoid delays.
- Compile Critical Documents: Prepare Device and Plant Master Files using expert templates.
- Plan for Audit: Identify a notified body or CDSCO inspection timeline.
- Submit Manufacturing License Application (Form MD7): Complete the electronic application.
- Prepare for Query Responses: Assign a regulatory point of contact.
By following this structured approach and leveraging our expertise, manufacturers and importers of the knee joint femorotibial prosthesis can efficiently secure CDSCO licenses and confidently enter the Indian market.
For detailed assistance, explore our MD9 License Guide and connect with our regulatory consultants today.
