CDSCO License for Oxygen administration hood, paediatric
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 device consisting of a rigid/semi-rigid transparent plastic shell that forms an enclosure over an infant's whole body, or the head only, in order to provide an enriched environment of oxygen (O2) to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It is designed to be used for patients adverse to oxygen delivery devices such as a nasal cannula or face mask. This device may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors. This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Oxygen Administration Hood (Paediatric) – Class A Medical Device
As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing maze, we understand the unique challenges faced by manufacturers of paediatric devices like the Oxygen Administration Hood. This device—a rigid or semi-rigid transparent enclosure designed to provide enriched oxygen to infants—falls under Class A, the lowest risk category, but still requires strict regulatory compliance before it can be marketed in India.
Understanding the Oxygen Administration Hood and Its Regulatory Importance
The Oxygen Administration Hood is an essential pediatrics and neonatology device designed to deliver oxygen in a controlled environment, especially for infants who cannot tolerate nasal cannulas or face masks. Due to its direct impact on vulnerable populations, regulatory oversight ensures safety, quality, and efficacy. The Central Drugs Standard Control Organisation (CDSCO) governs this, with specific licensing pathways for Class A devices.
CDSCO Regulatory Framework for Oxygen Administration Hood (Paediatric)
This device is notified under File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021, under the Medical Device Rules (MDR) 2017. As a Class A device, it falls under the State Licensing Authority jurisdiction for manufacturing licenses (MD5) but under the Central Licensing Authority for import licenses (MD15).
Risk Classification and License Requirements
- Risk Class: A (Low Risk)
- Manufacturing License: MD5 (Form MD3 application)
- Import License: MD15 (Form MD14 application)
Class A devices like the Oxygen Administration Hood benefit from a relatively streamlined process but still demand stringent documentation and testing before approval.
Manufacturing License Process (MD5 License) for Class A Devices
The MD5 manufacturing license is granted by the State Licensing Authority and takes approximately 3-4 months to complete. The process involves several sequential steps:
- Apply for a Test License (Form MD13): This initial step authorizes product testing and takes around 1.5-2 months.
- Product Testing: Mandatory testing must be conducted at CDSCO-approved laboratories to verify compliance with applicable standards. You can find the list of approved testing laboratories here.
- Document Preparation: Prepare complete documentation including Device Master File, Plant Master File, Risk Management File, and others detailed below.
- Submission of MD5 License Application (Form MD3): Upload your application on the CDSCO MD Online Portal.
- Audit by Notified Body: An audit is conducted by a notified body authorized to inspect Class A device manufacturers. Refer to the list of notified bodies to select your auditor.
- Resolution of Queries: Address any observations or queries raised during audit or by the licensing authority.
- Grant of MD5 License: Upon satisfactory compliance, the license is issued on Form MD5.
Manufacturing License Documents Required for Oxygen Administration Hood
To ensure smooth approval, you must submit the following:
- Company Constitution documents (e.g., Memorandum and Articles of Association)
- Proof of ownership or lease agreement for manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File: Detailed design and manufacturing info (see our Device Master File guide)
- Plant Master File: Manufacturing facility details and quality processes (refer to our Plant Master File guide)
- Essential Principles Checklist compliance
- Risk Management File demonstrating hazard analysis and mitigation (see Risk Management practices)
- Test reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) documents, typically ISO 13485:2016 certification
Import License Process (MD15 License) for Class A Devices
If you plan to import Oxygen Administration Hoods, the MD15 license is mandatory and granted by the Central Licensing Authority. The process typically takes 5-6 months and involves:
- Comprehensive document preparation including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate (if applicable), Device and Plant Master Files
- Submission of application on the CDSCO MD Online Portal
- Resolution of department queries
- Grant of MD15 license
Note that unlike manufacturing, import licensing does not require a test license or audit but demands robust documentation and compliance evidence.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5-2 months |
| Product Testing | 1-1.5 months |
| Documentation Preparation | 2-3 weeks |
| Application Submission & Audit | 1-1.5 months |
| Query Resolution and Licensing | 2-3 weeks |
Total time for MD5 manufacturing license: Approximately 3-4 months.
Total time for MD15 import license: Approximately 5-6 months.
Government Fees and Costs
- MD5 License: Rs. 5,000 per application + Rs. 500 per product
- MD15 Import License: For Class A devices, 50 per product (approx. Rs. 75,000 + Rs. 3,750 per product at current exchange rates)
Budgeting for these fees early on helps avoid surprises.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage CDSCO-approved labs early and schedule testing slots in advance. Maintain clear communication to expedite reports.
Challenge 2: Incomplete or Non-compliant Documentation
- Solution: Use checklists aligned with CDSCO guidelines. Our detailed Device Master File and Plant Master File guides can streamline preparation.
Challenge 3: Audit Non-conformities
- Solution: Conduct internal audits and mock inspections before notified body visits.
Challenge 4: Resolving Queries Quickly
- Solution: Designate a regulatory expert for prompt query responses and document resubmissions.
Expert Consultation and Support
Navigating CDSCO’s regulatory landscape requires expertise. With decades of hands-on experience, we offer tailored consulting to accelerate your license acquisition with minimal roadblocks. From gap analysis to document drafting, audit support, and liaison with authorities, our comprehensive services ensure your Oxygen Administration Hood reaches the Indian market without delay.
Getting Started with Your CDSCO License Application
- Register on the CDSCO MD Online Portal: Begin your journey by creating an account at the CDSCO MD Online Portal.
- Obtain a Test License (Form MD13): For manufacturing, secure your test license to initiate product testing.
- Select a CDSCO-Approved Testing Laboratory: Choose from the official list to ensure valid test reports.
- Prepare Complete Documentation: Leverage our guides for Device and Plant Master Files, Risk Management, and QMS compliance.
- Schedule the Notified Body Audit: Coordinate with an approved notified body early to avoid scheduling delays.
- Submit Your Application (Form MD3 for MD5 license): Upload via the online portal and track status regularly.
- Prepare for Query Resolution: Assign a dedicated team to handle any departmental or auditor queries promptly.
By following these actionable steps and leveraging expert guidance, your Oxygen Administration Hood (Paediatric) manufacturing or import license application will proceed smoothly, bringing this vital device to Indian healthcare providers and patients efficiently.
For further personalized assistance, feel free to contact us to discuss your specific project requirements and timelines.
