CDSCO License for Tracheobronchial Suction Catheter
Medical Device Information
Intended Use
Clearing the airways of mucus, pus, or aspirated materials to improve oxygena tion and ventilation.
Comprehensive Guide to CDSCO Licensing for Tracheobronchial Suction Catheter (Class B)
As a specialized medical device regulatory consultancy with over 25 years of experience and having supported 500+ manufacturers and importers, we understand the complexities involved in navigating India's CDSCO (Central Drugs Standard Control Organization) licensing system. This guide focuses specifically on the Tracheobronchial Suction Catheter, classified as a Class B device under CDSCO regulations, and aims to provide you with detailed, actionable steps to obtain your manufacturing or import license efficiently.
Understanding the Device and Regulatory Importance
The Tracheobronchial Suction Catheter is a critical medical device used to clear patients’ airways of mucus, pus, or aspirated material to help maintain optimal oxygenation and ventilation. Given its invasive use and direct impact on patient safety, CDSCO classifies this device as Class B—indicating a low to moderate risk profile that requires a stringent but not overly burdensome regulatory oversight.
CDSCO Regulatory Framework for Tracheobronchial Suction Catheter
This device falls under the Catheters category and is regulated under the CDSCO medical device notifications, specifically Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. Manufacturers intending to produce this device in India must obtain an MD5 manufacturing license, while importers require an MD15 import license.
Risk Classification and License Requirements
- Risk Class: B (Low to Moderate Risk)
- Manufacturing License: MD5 (Form MD3 application)
- Import License: MD15 (Form MD14 application)
Manufacturing License Process (MD5) for Class B Devices
The manufacturing license for your Tracheobronchial Suction Catheter is granted by the State Licensing Authority and involves several key steps:
- Apply for Test License (Form MD13): Before full license application, obtain a test license, which typically takes 1.5 to 2 months.
- Product Testing: Submit your catheter samples to government-approved testing laboratories. You can find a list of authorized labs on the CDSCO Testing Laboratories page.
- Document Preparation: Prepare the complete dossier including your Device Master File, Plant Master File, Risk Management File, and more.
- Submit MD5 Application (Form MD3): File your manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: A mandatory audit by a notified body is conducted to inspect your manufacturing site and QMS. Refer to the Notified Bodies List for authorized agencies.
- Query Resolution: Address any queries raised by the CDSCO department or notified body.
- Grant of License: Upon successful completion, the MD5 license is issued.
Manufacturing License Documents Required
Ensure your application includes the following comprehensive documentation:
- Company Constitution and Registration Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design, raw materials, manufacturing process (refer to our Device Master File guide)
- Plant Master File (PMF) describing your facility and equipment (see Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File outlining hazard analysis and mitigation (Risk Management insights)
- Product Test Reports from approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation (ISO 13485:2016 preferred)
Import License Process (MD15) for Tracheobronchial Suction Catheter
Importers looking to bring this device into India must apply for an MD15 license, granted by the Central Licensing Authority. The steps include:
- Document Preparation: Collate necessary certificates such as Free Sale Certificate, ISO 13485:2016, CE certificate, and manufacturing license from the country of origin.
- Submit MD15 Application (Form MD14): Apply via the CDSCO MD Online Portal.
- Departmental Review and Queries: Respond promptly to any clarifications.
- Grant of Import License: Usually completed within 5-6 months.
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 (if applicable)
- Company Constitution
Timeline and Processing Duration
| License Type | Step | Duration |
|---|---|---|
| MD5 Manufacturing | Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 month | |
| Application Submission & Audit | 1.5 - 2 months | |
| Query Resolution | 2 weeks - 1 month | |
| Total | 3-4 months | |
| MD15 Import | Application & Review | 5-6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B) | INR 5,000 | INR 500 |
| MD15 Import (Class B) | USD 2,000 (~INR 1.6 Lakhs) | USD 1,000 (~INR 80,000) |
Note: These fees are payable online through the CDSCO portal during application.
Common Challenges and Solutions
- Delayed Testing Reports: Opt for government-approved labs with faster turnaround times and pre-book testing slots early.
- Incomplete Documentation: Use detailed checklists and consult regulatory experts to avoid common pitfalls like missing Device Master File elements or inadequate risk analysis.
- Audit Non-Compliance: Conduct internal mock audits before notified body visits to identify gaps.
- Query Management Delays: Assign dedicated personnel to respond quickly to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our regulatory consultants bring hands-on expertise in preparing robust dossiers, coordinating with notified bodies, and expediting approvals for Class B devices like your Tracheobronchial Suction Catheter. We provide end-to-end support from initial product classification to post-license compliance.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device risk class and regulatory requirements.
- Gather Required Documentation: Begin compiling your Device Master File, Plant Master File, and Quality Management System documents.
- Schedule Product Testing: Contact government-approved labs early to plan testing timelines.
- Register on CDSCO MD Online Portal: Create your user account to submit applications electronically.
- Plan for Audit: Prepare your manufacturing site and documentation for the notified body inspection.
- Engage Expert Assistance: Consider consulting regulatory professionals to streamline the process.
By following this structured approach and leveraging our 25+ years of regulatory experience, you can successfully secure your CDSCO manufacturing or import license for the Tracheobronchial Suction Catheter, ensuring timely market entry and compliance with Indian regulatory standards.
For detailed guidance on the MD5 licensing process, visit our MD5 License Guide. To learn more about import licensing, see our Import License Guide.
If you are ready to begin your application or require personalized support, contact our expert team today to ensure a seamless CDSCO licensing journey.
