CDSCO License for Knee immobilizer
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Intended to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy.
Comprehensive Guide to CDSCO Licensing for Knee Immobilizer (Class A Medical Device)
As a medical device manufacturer or importer aiming to enter the Indian market with a Knee Immobilizer, understanding the regulatory framework of CDSCO (Central Drugs Standard Control Organization) is crucial. With over 25 years of expertise and having supported 500+ companies, we provide you with detailed insights on obtaining the essential CDSCO license for your device.
Introduction: Knee Immobilizer and Its Regulatory Importance
A Knee Immobilizer is a Class A medical device designed to temporarily render the knee immovable, typically used preoperatively or post-injury/arthroscopy as physical support. Given its critical role in patient care, regulatory compliance ensures safety, efficacy, and market access in India.
The device falls under the notified category with File No. 29/Misc./03/2020-DC (202) dated 26.7.2021. This Class A classification means it is considered low risk but still requires proper licensing to manufacture or import.
CDSCO Regulatory Framework for Knee Immobilizer
The CDSCO regulates medical devices based on risk class. For Knee Immobilizers (Class A), the manufacturing license is issued by the State Licensing Authority through the MD5 license process. The framework ensures:
- Quality Management System compliance
- Product testing and validation
- Inspection and audit by notified bodies
- Adherence to Essential Principles and Risk Management
Understanding this framework helps streamline your licensing process.
Risk Classification and License Requirements for Class A Devices
Knee Immobilizers are classified as Class A (low risk) devices. The associated license is the MD5 license (Form MD3 application), granted by the State Licensing Authority. This requires:
- Obtaining a Test License (MD13) initially
- Product testing by CDSCO-approved labs
- Document preparation including Device Master File and Plant Master File
- Audit by a notified body before final license grant
For detailed risk classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Knee Immobilizer
Apply for Test License (Form MD13): This is mandatory before manufacturing. The test license allows sample products to be tested for compliance. It typically takes 1.5 to 2 months.
Product Testing: Samples must be tested at government-recognized labs. You can find approved facilities in the Testing Laboratories list.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documents.
Submit Manufacturing License Application (Form MD3): Once testing is complete, submit the MD5 application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit of your manufacturing facility is conducted by a notified body from the Notified Bodies List. This ensures compliance with regulatory standards.
Resolve Queries: Address any queries raised by the department or notified body promptly.
License Grant: Upon successful audit and document verification, the State Licensing Authority grants the MD5 license.
Explore our detailed MD5 License Guide for step-by-step assistance.
Manufacturing License Documents Required for Knee Immobilizer
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership/Lease of Manufacturing Premises
- Qualification and Experience Documents of Technical Staff
- Fire and Pollution NOC
- Device Master File (DMF) with device specifications and design
- Plant Master File (PMF) detailing manufacturing processes
- Essential Principles Checklist confirming compliance
- Risk Management File specific to Knee Immobilizer
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation
For comprehensive documentation preparation tips, review our guides on the Device Master File and Plant Master File.
Import License Process (MD15) for Knee Immobilizer
If you are an importer, the MD15 license is mandatory, issued by the Central Licensing Authority. The process includes:
- Preparing required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Submitting application on CDSCO MD Online Portal
- Responding to departmental queries
- Final license grant
The import license timeline is approximately 5-6 months. For detailed guidance, see our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| Application Submission & Audit | 1 to 1.5 months |
| Query Resolution & License Grant | 2 to 4 weeks |
Total time for MD5 license: Approximately 3 to 4 months.
Government Fees and Costs
- Test License (MD13): Included in application
- MD5 Manufacturing License Fees:
- Application fee: Rs. 5000 per application
- Product fee: Rs. 500 per product
These fees are payable via the online portal during application submission.
Common Challenges and Solutions
- Delayed Document Preparation: Start early with device and plant master files. Use templates to avoid delays.
- Audit Non-compliance: Conduct internal audits aligned with notified body checklists to ensure readiness.
- Test Lab Backlogs: Engage approved labs early and schedule testing promptly.
- Query Resolution Delays: Maintain clear communication with CDSCO and prepare comprehensive responses.
Leveraging our experience, we recommend a proactive approach to each stage to prevent bottlenecks.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our expert regulatory consultants have helped over 500 companies successfully obtain licenses for Class A devices like Knee Immobilizers. We offer:
- Gap analysis of your documentation and QMS
- Assistance in preparing master files and essential principles checklists
- Coordination with notified bodies and testing labs
- End-to-end application management on the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
To initiate your licensing process for the Knee Immobilizer:
- Register your company on the CDSCO MD Online Portal.
- Prepare and submit the Test License application (Form MD13).
- Arrange for product sample testing through CDSCO-approved labs.
- Begin compiling your Device Master File and Plant Master File concurrently.
- Schedule audits with a notified body from the Notified Bodies List.
- Upon successful test license and product testing, submit your MD5 application (Form MD3).
By following this roadmap with expert guidance, you can achieve timely market authorization for your Knee Immobilizer, ensuring compliance and accelerating your product's entry into India.
For personalized support and detailed consultancy, contact us today and leverage our 25+ years of regulatory expertise.
