CDSCO License for Aerosol tent, paediatric
Medical Device Information
Intended Use
A flexible enclosure designed to cover the bed of a infant or small child to provide an aerosolized environment of breathing gases/vapours, e.g., a suspension of medicated liquid or solid particles, for medication therapy. Typically used for the treatment of breathing disorders (e.g., asthma). It typically consists of a metal frame covered with transparent plastic, and wide bore tubing connected to the aerosol source and is used for the treatment of paediatric patients permitting them movement without restriction. This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Paediatric Aerosol Tent (Class B Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the paediatric aerosol tent. With over 25 years of experience and having supported 500+ companies in successfully obtaining CDSCO licenses, we bring you an expert, step-by-step guide tailored specifically for manufacturers and importers of this Class B medical device.
Introduction: Paediatric Aerosol Tent and Its Regulatory Importance
The paediatric aerosol tent is a vital device in pediatrics and neonatology, designed as a flexible enclosure that covers an infant’s or small child’s bed to provide an aerosolized environment for therapeutic breathing gases or medicated vapours. Its reusable nature and direct impact on respiratory therapy make it a regulated medical device under the Indian regulatory framework.
Ensuring compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing this device into the Indian market. Proper licensing guarantees the device meets safety, quality, and efficacy standards, thus protecting vulnerable patients.
CDSCO Regulatory Framework for Paediatric Aerosol Tent
The CDSCO governs medical devices through structured regulatory pathways based on risk classification. The paediatric aerosol tent falls under Class B (low-moderate risk), which requires a manufacturing license under the MD5 category for domestic production and an MD15 import license for imported devices.
For comprehensive classification details, visit our Medical Device Classification guide.
Risk Classification and License Requirements for Class B Devices
- Risk Class: B (Low-moderate risk)
- License Type: MD5 Manufacturing License (Form MD3 application)
- Issuing Authority: State Licensing Authority
- Typical Timeline: 3 to 4 months (including test license, testing, audit)
- Fees: Rs 5,000 per application + Rs 500 per product
Manufacturing License Process for Paediatric Aerosol Tent (MD5 License)
- Apply for Test License (Form MD13): This preliminary license permits product testing and usually takes 1.5 to 2 months.
- Product Testing: Conduct mandatory testing through government-approved labs listed on the CDSCO Testing Laboratories portal.
- Document Preparation: Compile all required documents, including technical and quality system files.
- Submit MD5 License Application (Form MD3): File your detailed application through the CDSCO MD Online Portal.
- Notified Body Audit: An external audit is conducted by a notified body (refer to the Notified Bodies List).
- Respond to Queries: Address any clarifications or observations raised by CDSCO or the notified body.
- License Grant: Upon successful completion, the MD5 license is issued on Form MD5.
For a stepwise explanation, our MD5 License Guide is an excellent resource.
Manufacturing License Documents Required for Paediatric Aerosol Tent
Ensure the following documents are ready and compliant:
- Company Constitution (e.g., Partnership Deed, Memorandum of Association)
- Proof of Ownership/Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File detailing design, specifications, and intended use (Guide on Device Master File)
- Plant Master File outlining manufacturing infrastructure and processes (Plant Master File Guide)
- Essential Principles Checklist verifying compliance with regulatory standards
- Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
- Product Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified
Import License Process for Paediatric Aerosol Tent (MD15 License)
If you intend to import the paediatric aerosol tent into India, the following process applies:
- Document Preparation: Gather all required licenses and certifications.
- Submit MD15 License Application (Form MD14): File via the CDSCO online portal.
- Query Resolution: Respond promptly to any CDSCO queries.
- License Grant: MD15 license issued upon approval.
This process typically takes 5 to 6 months. Detailed steps and document requirements are covered in our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Certificate
- CE Certificate or equivalent international quality certification
- Device Master File and Plant Master File
- Wholesale License for distribution in India
- Company Constitution documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Application Preparation | 2 to 3 weeks |
| Audit by Notified Body | 3 to 4 weeks |
| Query Resolution & License Grant | 2 to 4 weeks |
Total Estimated Time: 3 to 4 months for MD5 manufacturing license.
Government Fees and Costs
- MD5 Manufacturing License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
- Test License (MD13): Included in above
- Product Testing: Varies by laboratory; typically Rs 50,000 to Rs 1,00,000 depending on test scope
- Notified Body Audit: Fees vary by notified body; typically Rs 50,000 to Rs 1,50,000
Budget planning should account for all these elements to avoid delays.
Common Challenges and Practical Solutions
- Delays in Product Testing: Engage certified labs early and confirm their capacity to test paediatric aerosol tents.
- Incomplete Documentation: Use checklists and consult expert regulatory consultants to ensure all files are thorough.
- Audit Non-Compliance: Prepare your manufacturing site per notified body guidelines; conduct internal audits beforehand.
- Query Resolution Delays: Assign dedicated personnel for prompt and accurate responses to CDSCO queries.
Expert Consultation and Support
With our extensive experience assisting over 500 companies, we offer tailored support:
- Document preparation and review
- Coordination with notified bodies and testing labs
- Mock audits and compliance training
- Strategic regulatory planning to expedite approvals
Our proactive approach minimizes risks and accelerates your time-to-market.
Getting Started with Your CDSCO License Application for Paediatric Aerosol Tent
- Assess Your Device Classification: Confirm Class B status using CDSCO guidelines.
- Prepare Your Device and Plant Master Files: Crucial for audit and licensing.
- Apply for Test License (MD13) via the CDSCO MD Online Portal: Initiate product testing.
- Engage a Notified Body Early: Schedule your audit well in advance.
- Compile Complete Application Package: Ensure all documents are accurate and current.
- Submit MD5 License Application: File formally after successful testing.
Taking these actionable steps with expert guidance ensures smoother navigation through India’s regulatory requirements for your paediatric aerosol tent. We invite you to contact us for personalized consultation and support to secure your CDSCO license efficiently and compliantly.
