CDSCO License for Unilateral External Fixation System

Comprehensive CDSCO Licensing Guide for Unilateral External Fixation System (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience assisting 500+ companies in India, we understand the nuances of obtaining CDSCO licenses for medical devices like the Unilateral External Fixation System. This guide offers in-depth, practical insights tailored specifically for Class B devices under the General Hospital or Orthopaedic Instruments category, helping manufacturers and importers smoothly navigate the regulatory landscape.

Understanding Your Device and Its Regulatory Importance

The Unilateral External Fixation System is a vital orthopedic device consisting of rods, clamps, spanners, compressors, and screw guides designed for external fixation of bones. Due to its direct application in orthopedic surgeries, regulatory compliance is crucial to ensure safety, effectiveness, and market authorization in India.

The Central Drugs Standard Control Organization (CDSCO) regulates such devices under the Medical Device Rules (MDR) 2017, updated periodically. Your device falls under Class B (low moderate risk), requiring a thorough but streamlined licensing process via the State Licensing Authority.

CDSCO Regulatory Framework for Unilateral External Fixation System

The device is notified under Notification No. 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. As per the Medical Device Classification, Class B devices like yours need to comply with specific technical and quality standards before marketing.

Your licensing journey will primarily involve the MD5 license for manufacturing within India, governed by the State Licensing Authority. If you intend to import, the MD15 import license from the Central Licensing Authority is necessary.

Risk Classification and License Requirements

• Risk Class: B (Low moderate risk)
• License Type for Manufacturing: MD5 (Application Form MD3)
• Issuing Authority: State Licensing Authority
• Total Processing Time: Approximately 3-4 months
• Test License Requirement: Yes, Test License on Form MD13 (approx. 1.5-2 months)

The classification impacts the documentation, fees, and audit procedures you must follow.

Manufacturing License Process (MD5 License)

1. Obtain Test License (Form MD13): Before applying for the manufacturing license, secure a test license for your device. This allows you to conduct necessary testing in approved laboratories and is mandatory for Class B devices.

2. Product Testing: Conduct tests as per Indian standards in government-approved labs listed on the CDSCO Testing Laboratories page.

3. Document Preparation: Compile essential documents including Device Master File, Plant Master File, QMS documents, and test reports.

4. Application Submission: Submit the manufacturing license application on Form MD3 via the CDSCO MD Online Portal.

5. Audit: A notified body, selected from the list of notified bodies, will conduct an audit of your manufacturing facility.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. License Grant: Upon successful audit and document verification, the State Licensing Authority will issue the manufacturing license (Form MD5).

Manufacturing License Documents Required

For your Unilateral External Fixation System, expect to prepare and submit the following:

• Company Constitution Documents (Incorporation certificates, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing device design, specifications (Device Master File Guide)
• Plant Master File (PMF) describing the manufacturing facility (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation plans (Risk Management)
• Test Reports from government-approved laboratories
• Labels, Packaging, and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (preferably ISO 13485:2016 certified)

Import License Process (MD15 License)

If you plan to import the Unilateral External Fixation System, the MD15 license is mandatory. The process involves:

1. Document Preparation: Assemble all requisite documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.

2. Application Submission: Apply through Form MD14 on the CDSCO MD Online Portal.

3. Review and Query Resolution: Address any clarifications raised by the Central Licensing Authority.

4. License Grant: The import license (Form MD15) is issued post verification.

Note: Unlike manufacturing, no test license is required for import.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License valid in India
• Company Constitution and Incorporation documents

Timeline and Processing Duration

Government Fees and Costs

For your Class B Unilateral External Fixation System:

• MD5 License (Manufacturing):

  • Rs. 5,000 per application
  • Rs. 500 per product

• MD15 License (Import):

  • Rs. 2,000 per site
  • Rs. 1,000 per product

Budgeting for notified body audits, testing fees at approved labs, and internal QMS implementation is crucial. Testing fees vary depending on the lab and scope.

Common Challenges and Solutions

• Delayed Test Reports: Collaborate with CDSCO-approved testing laboratories early to schedule tests and avoid bottlenecks.
• Incomplete Documentation: Use checklists and templates from expert resources such as our Device Master File Guide to ensure completeness.
• Audit Non-Compliance: Prepare meticulously for notified body audits by conducting internal audits and staff training.
• Query Resolution Delays: Assign a dedicated regulatory officer to respond promptly to CDSCO queries.

Expert Consultation and Support

With decades of experience, we provide end-to-end support:

• Device classification confirmation
• Preparation of Plant and Device Master Files
• Assistance with test license and manufacturing/import license applications
• Coordination with notified bodies and testing labs
• Training and readiness for audits

Our proven track record in securing over 500 CDSCO licenses ensures you avoid common pitfalls and expedite market entry.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Verify your Unilateral External Fixation System is Class B per the latest CDSCO rules.

2. Prepare Technical Documentation: Start compiling your Device Master File, Plant Master File, QMS, and Risk Management File.

3. Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to obtain the test license.

4. Schedule Testing: Book slots with government-approved labs early to avoid delays.

5. Plan for Audit: Select a notified body from the CDSCO Notified Bodies List and prepare your facility.

6. Apply for Manufacturing License: Once testing and documentation are complete, file Form MD3 for the MD5 license.

7. Monitor Application Status: Regularly check updates on the CDSCO portal and respond swiftly to queries.

By following these tailored steps and leveraging expert guidance, your Unilateral External Fixation System can achieve regulatory compliance efficiently, opening doors to the Indian healthcare market.

For personalized assistance or detailed consultation, connect with our regulatory experts who have successfully navigated CDSCO licensing for hundreds of clients across India.