CDSCO License for Aerosol delivery tubing
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
A flexible tube used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer, intended for the delivery of aerosolized humidification, typically oxygen enriched.
Comprehensive Guide to CDSCO Licensing for Aerosol Delivery Tubing (Class A Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and having assisted 500+ medical device companies, we understand the nuances of navigating the Central Drugs Standard Control Organization (CDSCO) licensing process in India. This guide focuses on the Aerosol Delivery Tubing, a Class A device under the Anesthesiology category, detailing the step-by-step process to secure your MD5 manufacturing license.
Introduction to Aerosol Delivery Tubing and Regulatory Importance
Aerosol delivery tubing is a critical flexible tubing used alongside oxygen masks, endotracheal tubes, humidifiers, or nebulizers. It facilitates the delivery of aerosolized humidified gases, often oxygen-enriched, essential in anesthesiology and respiratory care. Given its direct patient interface, even as a low-risk Class A device, regulatory compliance is mandatory to ensure patient safety and quality standards.
The CDSCO license validates your product's conformity with Indian regulations, enabling legal manufacturing and marketing within the country. Without this license, entry into the Indian healthcare market is prohibited.
CDSCO Regulatory Framework for Aerosol Delivery Tubing
This device falls under Class A (low risk) as per the Medical Device Rules 2017, notified under the Ministry of Health and Family Welfare notification (29/Misc/03/2020-DC(177), dated 12.07.2021). The licensing authority for Class A devices is the respective State Licensing Authority, and the applicable license is the MD5 license granted under Form MD3.
For comprehensive understanding of device classification, visit our Medical Device Classification guide.
Risk Classification and License Requirements for Aerosol Delivery Tubing
- Risk Class: A (Low risk)
- License Type: MD5 (Manufacturing license for Class A and B devices)
- Licensing Authority: State Licensing Authority
- Application Form: MD3 for license
- Pre-requisite: Test license on Form MD13
Manufacturing License Process (MD5) for Aerosol Delivery Tubing
The MD5 licensing process involves several sequential steps:
Test License Application (Form MD13): Apply for a test license to manufacture and test your device. This stage typically takes 1.5 to 2 months.
Testing of Device: Samples must be tested at CDSCO-approved government labs. Refer to the Testing Laboratories list to select the appropriate facility.
Preparation of Required Documentation: Compile all technical and quality documents, including Device Master File and Plant Master File.
Submission of MD5 License Application (Form MD3): Apply via the official CDSCO MD Online Portal.
Audit by Notified Body: An audit by a notified body is mandatory. Select your auditor from the List of Notified Bodies.
Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
Grant of License: Upon successful completion, the license is issued in Form MD5.
Manufacturing License Documents Required for MD5
For aerosol delivery tubing, ensure you have the following documents ready:
- Company Constitution (e.g., MoA, AoA)
- Proof of ownership or lease agreement of manufacturing premises
- Qualification and experience documents of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design and manufacturing info. Our Device Master File guide can help you prepare this critical document.
- Plant Master File (PMF): Information about manufacturing infrastructure and processes. Refer to our Plant Master File guide.
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File addressing potential device risks (Risk Management Guide)
- Test Reports from approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 compliant
Import License Process (MD15) for Aerosol Delivery Tubing
While this device is Class A and primarily requires an MD5 manufacturing license, importers need to obtain an MD15 import license from the Central Licensing Authority.
Key steps include:
- Submission of Form MD14 for import license
- Provision of supporting documents such as manufacturing license, Free Sale Certificate, ISO 13485 certificate, CE Certificate, Device Master File, Plant Master File, and wholesale license
- Resolution of any queries raised by CDSCO
- License grant on Form MD15
For detailed guidance, consult our Import License Guide.
Import License Documents Required
- Valid Manufacturing License (MD5 or MD9) from the country of origin
- Free Sale Certificate (FSC) or Certificate to Foreign Government (CFG)
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale Drug License
- Company Constitution documents
Timeline and Processing Duration
| Stage | Estimated Duration |
|---|---|
| Test License (Form MD13) | 1.5 – 2 months |
| Device Testing | 3 – 4 weeks |
| MD5 License Application Review | 1 – 1.5 months |
| Audit and Query Resolution | 2 – 3 weeks |
| Total Time | Approximately 3 – 4 months |
The total process from test license application to final MD5 license grant typically spans 3 to 4 months. Delays often arise due to incomplete documentation or audit scheduling.
Government Fees and Costs
- Test License (MD13): Included in MD5 application process
- MD5 License Fee:
- Application Fee: ₹5,000
- Per Product Fee: ₹500
For aerosol delivery tubing, expect the total government fee to range between ₹5,500 to ₹6,000 depending on the number of product variants.
Additional costs include notified body audit fees (variable) and testing laboratory charges.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all documents, especially Device Master File and Risk Management File, are comprehensive and up to date.
- Delayed Testing: Pre-book testing slots at government-approved labs early to avoid bottlenecks.
- Audit Scheduling Conflicts: Engage notified bodies early and maintain open communication to schedule audits timely.
- Query Response Delays: Assign a dedicated regulatory contact to address CDSCO queries swiftly.
Expert Consultation and Support
Navigating the CDSCO licensing maze for aerosol delivery tubing can be complex. With our extensive experience assisting over 500 companies, we provide tailored support for:
- Document preparation and gap analysis
- Device and Plant Master File creation
- Application submission and follow-up
- Audit readiness and liaison with notified bodies
- Post-license compliance and renewals
Our expert guidance significantly reduces timelines and minimizes rejections.
Getting Started with Your CDSCO License Application
- Verify Device Classification: Confirm your aerosol delivery tubing is Class A.
- Prepare Documentation: Use our linked guides to draft Device and Plant Master Files.
- Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
- Coordinate Testing: Arrange sample testing at a CDSCO-approved lab.
- Engage Notified Body: Select a notified body from the official list and schedule the audit.
- Submit MD5 Application (Form MD3): After test license and testing, apply online.
- Respond to Queries Promptly: Maintain transparent communication with CDSCO.
Embarking on your licensing journey with a clear plan and expert support ensures smooth market entry for your aerosol delivery tubing. Contact us today to leverage our proven strategies and expedite your CDSCO MD5 license approval.
