CDSCO License for Bronchography Catheter
Medical Device Information
Intended Use
Intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or
Comprehensive Guide to CDSCO Licensing for Bronchography Catheters (Class B)
Bronchography Catheters play a vital role in delivering therapeutic and diagnostic agents to the airway and tracheal regions. Given their critical clinical applications, regulatory compliance is paramount to ensure safety, efficacy, and market access in India. With over 25 years of experience and having assisted 500+ companies in navigating the CDSCO licensing framework, we provide you with a detailed roadmap to secure your CDSCO license for Bronchography Catheters.
Understanding the CDSCO Regulatory Framework for Bronchography Catheters
In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Devices Rules, 2017. Bronchography Catheters fall under the 'Catheters' category with a Risk Class B classification as per the notification 29/Misc/3/2017-DC (292), dated 06.06.2018. This classification defines your licensing requirements, audit protocols, and compliance obligations.
Risk Classification and License Requirements for Class B Devices
Class B devices represent low to moderate risk, necessitating a manufacturing license known as the MD5 license, issued by the State Licensing Authority. This license mandates adherence to quality management systems, testing, and audit procedures tailored for such devices.
The Manufacturing License Process (MD5) for Bronchography Catheters
The process to obtain an MD5 license involves several key steps:
Test License Application (Form MD13): Initiate with a test license application, permitting limited manufacture for product testing. The processing time is approximately 1.5 to 2 months.
Product Testing: Submit your Bronchography Catheter samples to government-approved laboratories (Testing Laboratories) for safety and performance evaluation.
Documentation Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and more.
Manufacturing License Application (Form MD3): Apply for the MD5 license via the CDSCO MD Online Portal, attaching all required documents.
Audit by Notified Body: Engage with a notified body from the official Notified Bodies List for the mandatory factory audit.
Query Resolution: Address any queries from the licensing authority or notified body promptly.
Grant of License: Upon satisfactory compliance, the MD5 license is issued.
The entire process typically spans 3 to 4 months.
Manufacturing License Documents Required
For a Class B Bronchography Catheter, the documentation must be robust and complete:
- Company Constitution (e.g., Memorandum of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design and specifications (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing infrastructure (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with regulatory standards
- Risk Management File demonstrating risk identification and mitigation (Risk Management)
- Test Reports from government-approved labs
- Device Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, ideally ISO 13485 certified
Import License Process for Bronchography Catheters (MD15)
For importers, the MD15 license issued by the Central Licensing Authority is mandatory. Unlike manufacturing, the test license is not required here. The steps include:
Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Application submission on the CDSCO MD Online Portal.
Query resolution post-review.
License grant within approximately 5 to 6 months.
Import License Documents Required
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Process Stage | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Documentation Preparation | 3 - 4 weeks |
| Manufacturing License (MD5) | 1.5 - 2 months |
| Total Time for MD5 License | Approximately 3 - 4 months |
| Import License (MD15) | Approximately 5 - 6 months |
Government Fees and Costs
For Class B Bronchography Catheters, the fee structure is as follows:
- MD5 License: Rs 5,000 per application plus Rs 500 per product
- Test License (MD13): Included within the MD5 process
- Import License (MD15): Rs 2,000 per site plus Rs 1,000 per product
These fees are payable online through the CDSCO portal.
Common Challenges and Practical Solutions
Challenge 1: Delays in Testing – Testing at government-approved labs can be time-consuming due to backlog.
- Solution: Pre-book testing slots and consider multiple accredited labs to expedite.
Challenge 2: Incomplete Documentation – Missing or inconsistent documents lead to application rejections.
- Solution: Utilize comprehensive checklists and expert consultation to ensure completeness.
Challenge 3: Audit Non-compliance – Failure to meet notified body audit criteria can delay licensing.
- Solution: Conduct internal mock audits and staff training before the official audit.
Challenge 4: Query Management – Slow response to CDSCO queries prolongs processing.
- Solution: Assign dedicated regulatory personnel for prompt and thorough query resolution.
Expert Consultation and Support
Navigating CDSCO licensing for Bronchography Catheters requires precise knowledge and experience. With our proven track record assisting over 500 companies, we offer tailored support:
- Pre-audit consultancy
- Documentation preparation and review
- Regulatory strategy formulation
- Liaison with CDSCO and notified bodies
Our expertise ensures your application is robust, compliant, and expedites market entry.
Getting Started with Your CDSCO License Application for Bronchography Catheters
Assess Your Device Classification: Confirm your device’s Risk Class B status using the Medical Device Classification tool.
Prepare Essential Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
Plan Product Testing: Coordinate with government-approved testing laboratories for timely sample evaluation.
Schedule Factory Audit: Identify a notified body for the audit and prepare your manufacturing site accordingly.
Submit Manufacturing License Application (MD5): Once testing is completed, apply for the MD5 license online.
Engage with Regulatory Experts: Consider professional guidance to navigate complexities and avoid common pitfalls.
By following these actionable steps and leveraging expert support, manufacturers and importers of Bronchography Catheters can successfully obtain their CDSCO licenses, ensuring compliance and smooth access to the Indian healthcare market.
For further assistance and detailed consultation, feel free to contact our regulatory experts who specialize in medical device licensing in India.
