CDSCO License for Oxygen terminal unit
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 that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for oxygen (O2). It is designed to be mounted to wall-mounted medical supply units, utility supply systems (ceiling pendants), or directly to a wall, and functions as the outlet assembly of a gas pipeline system to which the operator can connect and disconnect a device, typically anaesthesia systems, ventilators, respiratory devices, infant incubators, and other devices that require O2 to function as intended. On disconnection of the medical device from the outlet, it will self seal the gas pipeline system preventing gas leakage to the environment.
Comprehensive Guide to CDSCO License for Oxygen Terminal Unit (Class A Medical Device)
As a vital component of medical gas pipeline systems, the Oxygen Terminal Unit plays a crucial role in delivering oxygen safely and efficiently to pediatric and neonatology patients. Given its significance in healthcare settings, obtaining the correct regulatory clearance from the Central Drugs Standard Control Organisation (CDSCO) is essential for manufacturers and importers aiming to market this device in India.
With over 25 years of experience assisting 500+ companies through India's medical device regulatory landscape, we provide you with a detailed, step-by-step guide tailored specifically for your Oxygen Terminal Unit—a Class A medical device.
CDSCO Regulatory Framework for Oxygen Terminal Units
The CDSCO governs medical device regulation in India under the Medical Device Rules (MDR) 2017. Oxygen Terminal Units fall under Class A, representing low risk devices. These devices must comply with essential principles ensuring safety, performance, and quality.
The regulatory framework requires manufacturers to obtain an MD5 manufacturing license granted by the State Licensing Authority. Importers, on the other hand, must obtain an MD15 import license from the Central Licensing Authority.
Risk Classification and License Requirements for Oxygen Terminal Unit
Your Oxygen Terminal Unit is classified as a Class A device under the MDR 2017 due to its role as a component in medical gas pipelines and its intended use in pediatrics and neonatology.
- Class A Devices: Low risk
- License Type: MD5 Manufacturing License (Form MD3)
- Regulatory Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months (including test license and audit)
- Fees: Rs 5,000 per application + Rs 500 per product
For comprehensive classification details, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Oxygen Terminal Unit
The manufacturing license process involves several critical steps:
Test License Application (Form MD13): Initial mandatory step to manufacture the device for testing purposes. This takes about 1.5 to 2 months.
Product Testing: Conduct testing at government-approved laboratories to confirm compliance with applicable standards. Access the list of approved testing laboratories.
Document Preparation: Assemble all technical, quality, and compliance documentation.
License Application (Form MD3): Submit your MD5 license application via the CDSCO MD Online Portal.
Notified Body Audit: Engage an approved notified body for audit of your manufacturing site and quality management system. Review the list of notified bodies to select one.
Queries Resolution: Address any observations or queries raised by the licensing authority or notified body.
License Grant: Upon successful compliance, the State Licensing Authority issues the MD5 license.
Manufacturing License Documents Required for Oxygen Terminal Unit
Preparing a complete and accurate dossier accelerates your approval process. The essential documents include:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design and manufacturing processes. Our Device Master File guide offers valuable insights.
- Plant Master File (PMF) describing the manufacturing facility. Learn how to create one in our Plant Master File guide.
- Essential Principles Checklist confirming compliance with MDR 2017
- Risk Management File illustrating hazard analysis and mitigation measures. See our Risk Management guide.
- Test Reports from government-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certified
Ensuring all documents are precise, clear, and compliant helps avoid unnecessary delays.
Import License Process (MD15) for Oxygen Terminal Unit
If you plan to import Oxygen Terminal Units into India rather than manufacture locally, an MD15 import license is mandatory.
Key steps include:
Document Preparation: Assemble all required certificates, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, and relevant technical files.
Application Submission: File application using Form MD14 on the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any additional information requests from CDSCO.
License Grant: The Central Licensing Authority issues the MD15 license.
Note that unlike manufacturing licenses, a test license is not required for import licenses.
Import License Documents Required:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
Fees vary by device class; for Class A devices, expect approximately 50 per product.
For detailed import licensing, consult our Import License guide.
Timeline and Processing Duration for Oxygen Terminal Unit Licensing
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 2 – 4 weeks |
| License Application (MD5) | Immediate after docs |
| Notified Body Audit | 2 – 3 weeks |
| Query Resolution | 2 – 4 weeks |
| Final License Grant | 1 week |
Total Estimated Time: 3 to 4 months for manufacturing license
Import licenses typically take 5 to 6 months due to central authority processing.
Government Fees and Costs for Oxygen Terminal Unit Licensing
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- Test License (MD13): Included in overall process
- Notified Body Audit Fees: Varies between notified bodies; typically ranges from Rs 50,000 to Rs 1,50,000
- Testing Laboratory Charges: Varies depending on tests; budget around Rs 50,000–1,00,000
Budgeting comprehensively for these costs upfront can prevent surprises and ensure smooth project management.
Common Challenges and Solutions in Licensing Oxygen Terminal Units
Incomplete Documentation: Missing or poorly prepared files are the top cause of delays. Solution: Use detailed checklists and expert review before submission.
Delayed Testing: Government labs can be backlogged. Solution: Schedule testing early and consider multiple approved labs.
Non-compliance in Audit: Audit findings often relate to QMS gaps. Solution: Implement ISO 13485:2016 and conduct internal audits before official inspection.
Slow Query Responses: Prolonged back-and-forth with CDSCO can stall approvals. Solution: Prepare thorough, clear responses and engage regulatory consultants if needed.
Expert Consultation and Support
Navigating CDSCO licensing can be daunting, especially for complex devices like Oxygen Terminal Units with pediatric applications. Our team, with 25+ years of regulatory expertise and a record of 500+ successful approvals, offers comprehensive support—from documentation preparation to audit readiness and query management.
Engaging experts early can reduce timelines by up to 30% and significantly improve approval success rates.
Getting Started with Your CDSCO License Application for Oxygen Terminal Unit
Assess Your Device Classification and Requirements: Confirm Class A status and understand MD5 licensing needs.
Prepare Your Technical Documentation: Begin compiling Device Master File, Plant Master File, Risk Management File, and all required certificates.
Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
Plan Product Testing: Schedule and conduct tests at approved laboratories.
Select a Notified Body: Choose an accredited notified body for audit; consult the Notified Bodies list.
Submit MD5 License Application: Once testing and documentation are ready, apply for the manufacturing license.
Prepare for Audit and Queries: Ensure your QMS and manufacturing site are audit-ready, and respond promptly to any CDSCO queries.
Embarking on regulatory approval for your Oxygen Terminal Unit with a structured, informed approach ensures timely market entry and compliance. For personalized assistance, reach out to our consultancy team who will guide you throughout the licensing journey.
By leveraging our deep regulatory insights and practical experience, you can confidently navigate the CDSCO licensing process for your Oxygen Terminal Unit and establish your presence in India’s vibrant medical device market.
