CDSCO License for Flexible video bronchoscope, reusable
Medical Device Information
Intended Use
An endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.
Comprehensive CDSCO Licensing Guide for Flexible Video Bronchoscope (Reusable) – Risk Class B
At our consultancy, with over 25 years of deep expertise in the Indian medical device regulatory landscape, we have successfully supported 500+ manufacturers and importers in navigating the CDSCO licensing process. This detailed guide focuses on the regulatory requirements for a Flexible Video Bronchoscope (Reusable), classified as Risk Class B under CDSCO regulations.
Introduction: Device Overview and Regulatory Importance
A flexible video bronchoscope is a critical reusable endoscopic medical device used primarily in oncology and respiratory diagnostics. Its flexible inserted portion enables visualization of the airway and tracheobronchial tree during bronchoscopy. The device incorporates advanced video technology, including a CCD chip, to provide real-time anatomical imaging on a monitor, assisting physicians in diagnosing lung infections, pneumonia, and cancers, as well as performing biopsies.
Given its invasive nature and reuse potential, regulatory scrutiny ensures patient safety and device efficacy. In India, the Central Drugs Standard Control Organisation (CDSCO) governs its manufacturing and import through stringent licensing frameworks.
CDSCO Regulatory Framework for Flexible Video Bronchoscope
Our experience confirms that flexible video bronchoscopes fall under Class B as per the Indian Medical Device Rules (MDR). This classification demands compliance with specific quality, safety, and performance standards.
To legally manufacture this device in India, manufacturers must obtain the MD5 manufacturing license from the State Licensing Authority. Importers require the MD15 import license from the Central Licensing Authority.
For comprehensive classification details, refer to our Medical Device Classification guide.
Risk Classification and License Requirements
- Risk Class: B (Low Moderate Risk)
- License Type for Manufacturing: MD5 (Form MD3 application)
- License Type for Import: MD15 (Form MD14 application)
- Regulatory Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import
Manufacturing License Process (MD5)
The MD5 license process for this reusable flexible video bronchoscope involves several key steps:
Test License Application (Form MD13): Initially, manufacturers must apply for a test license to produce limited samples for testing. This step usually takes 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved government laboratories. You can find authorized labs on the CDSCO Testing Laboratories List.
Document Preparation: After testing, prepare the full dossier including technical, quality, and risk management documentation.
MD5 Application Submission (Form MD3): Submit via the CDSCO MD Online Portal.
Audit by Notified Body: Class B devices require an audit by a notified body. Check the list of notified bodies for selection.
Resolution of Queries: Respond promptly to any deficiencies or queries from CDSCO or the notified body.
Grant of License: Upon successful audit and document verification, the MD5 license is granted.
The entire process typically spans 3 to 4 months post-test license issuance.
For detailed procedural insight, visit our MD5 License Guide.
Manufacturing License Documents Required
Successful MD5 license applications for reusable flexible video bronchoscopes must include:
- Company Constitution Documents: Incorporation certificate, partnership deed, or LLP agreement.
- Proof of Premises Ownership or Lease: Registered sale deed or lease agreement.
- Technical Staff Details: CVs and qualification certificates of key personnel such as qualified technical representatives.
- Fire Safety NOC: Issued by the local fire department.
- Pollution Control NOC: Environmental clearance or consent to operate.
- Device Master File (DMF): Comprehensive technical dossier. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Details of manufacturing facilities and quality systems. Refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian MDR essential principles.
- Risk Management File: Documented risk analysis and mitigation strategies aligned with ISO 14971. Learn more in our Risk Management guide.
- Test Reports: From CDSCO-approved labs confirming device safety and performance.
- Labels and Instructions for Use (IFU): Drafted in compliance with Indian regulations.
- Quality Management System Documents: ISO 13485:2016 certification and SOPs.
Import License Process (MD15)
If you plan to import the flexible video bronchoscope, the process differs:
- No Test License Required: The product must already have valid certifications.
- Document Preparation: Gather all requisite documents (detailed below).
- Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.
- Queries and Clarifications: Respond to any CDSCO queries.
- License Issuance: The MD15 license is granted by the Central Licensing Authority.
The import licensing timeline is generally 5 to 6 months due to central-level processing.
For detailed import license application support, explore our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate (FSC)
- ISO 13485:2016 Certification
- CE Certificate or Equivalent International Approval
- Device Master File
- Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 4 weeks |
| MD5 Application Processing | 6 - 8 weeks |
| Audit and Query Resolution | 4 - 6 weeks |
| Total Manufacturing License Process | 3 - 4 months |
| Import License (MD15) | 5 - 6 months |
Government Fees and Costs
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- MD13 Test License: Included in the above process
- MD15 Import License: Based on device class; for Class B devices approximately Rs 2,000 per site + Rs 1,000 per product
Note: Additional costs include notified body audit fees, testing lab charges, and consultancy fees if applicable.
Common Challenges and Practical Solutions
- Delayed Test Reports: Proactively coordinate with approved testing labs early. Use the CDSCO Testing Laboratories List to select labs with least backlog.
- Incomplete Documentation: Utilize checklists and templates for DMF, PMF, and Risk Management files to ensure completeness.
- Audit Non-compliance: Conduct internal mock audits before notified body inspections to identify gaps.
- Query Resolution Delays: Assign dedicated regulatory personnel for timely responses and document resubmissions.
Expert Consultation and Support
With our extensive track record of over 500 successful CDSCO licensing projects, we offer tailored regulatory consulting:
- End-to-end application preparation and submission
- Technical document creation and review
- Coordination with notified bodies and testing labs
- Audit readiness and post-audit compliance
Our proactive approach ensures your flexible video bronchoscope reaches the Indian market with minimal delays and full regulatory compliance.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class B; consult the official Medical Device Classification resource.
- Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our dedicated guides.
- Apply for Test License (MD13): Submit your initial application on the CDSCO MD Online Portal.
- Coordinate Product Testing: Schedule sample testing with CDSCO-approved laboratories.
- Plan for Audit: Select a notified body early and prepare for the compliance audit.
- Submit MD5 Application: After test license and product testing, file the manufacturing license application.
Embarking on this process with expert guidance maximizes your chances of timely approval and market entry. Contact us today to leverage our 25+ years of regulatory expertise in CDSCO licensing for your reusable flexible video bronchoscope.
For more detailed insights and personalized assistance, visit our comprehensive guides on MD5 License and Device Master File.
