CDSCO License for Airway Pressure / Oxygen Monitor
Medical Device Information
Intended Use
A mains electricity (AC-powered) device designed to continuously measure and display the breathing circuit pressure and oxygen (O2) concentration levels of respiratory gases delivered to a patient through positive pressure ventilation systems such as continuous positive airway pressure (CPAP) systems or ventilator respiratory circuits. It typically includes pressure and O2 level displays, alarms to signal pressure and O2 levels that exceed specified limits, and has connectors to allow attachment to the respiratory equipment; it is used for neonatal, paediatrics and adults. It may contain one or more rechargeable battery for independent/mobile use or when mains power is not available.
Comprehensive Guide to CDSCO Licensing for Airway Pressure / Oxygen Monitor (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully assisted more than 500 companies, we understand the critical importance of securing the right CDSCO license to manufacture or import medical devices in India. This comprehensive guide focuses on the Airway Pressure / Oxygen Monitor—a Class B medical device widely used in pediatric and neonatal care—and details the regulatory pathway, timelines, costs, documentation, and practical tips for smooth approval.
Understanding the Airway Pressure / Oxygen Monitor and Its Regulatory Importance
The Airway Pressure / Oxygen Monitor is an AC-powered device designed to continuously measure and display breathing circuit pressure and oxygen concentration levels in respiratory gases delivered to patients via CPAP systems or ventilators. It is essential in monitoring respiratory status across neonates, pediatric, and adult patients. Given its role in critical care, the device is classified as Class B under CDSCO regulations, reflecting moderate risk.
Regulatory compliance ensures the device meets safety, efficacy, and quality parameters mandated by Indian authorities, facilitating market access while safeguarding patient health. Non-compliance can lead to severe consequences including penalties, product recall, or denial of market entry.
CDSCO Regulatory Framework for Airway Pressure / Oxygen Monitor
In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The Airway Pressure / Oxygen Monitor falls under Class B risk category, requiring a State-level manufacturing license (MD5) or a Central-level import license (MD15) depending on the business activity.
Manufacturers must follow the Medical Device Rules (MDR) 2017 and subsequent amendments, submitting applications through the CDSCO MD Online Portal. The regulatory framework involves pre-market testing, documentation review, and facility audit before license issuance.
Risk Classification and License Requirements for This Device
- Risk Class: B (Moderate risk)
- Applicable License: MD5 Manufacturing License for Class B devices
- Issuing Authority: State Licensing Authority
- Process Overview: Test License (Form MD13) → Product Testing → Application for MD5 License (Form MD3) → Notified Body Audit → Query Resolution → License Grant
For importers, the MD15 license issued by CDSCO Central Licensing Authority applies.
Manufacturing License Process (MD5) for Airway Pressure / Oxygen Monitor
- Obtain Test License (Form MD13): Mandatory for initial product testing; takes approximately 1.5 to 2 months.
- Product Testing: Conduct testing of the device at government-approved laboratories to demonstrate compliance with applicable standards. Refer to the list of testing laboratories.
- Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
- Application Submission: Submit the MD5 license application (Form MD3) via the CDSCO MD Online Portal.
- Notified Body Audit: Engage a notified body for an on-site audit of manufacturing facilities. Check the list of notified bodies to select an authorized auditor.
- Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
- License Grant: Upon successful audit and documentation review, the MD5 manufacturing license is granted.
Complete process duration typically ranges from 3 to 4 months.
Manufacturing License Documents Required for Class B Devices
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Personnel
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) – covering design, specifications, manufacturing process, and validation. Our detailed Device Master File guide can assist in preparation.
- Plant Master File (PMF) – outlining facility layout, equipment, and quality management system. See our Plant Master File Guide for insights.
- Essential Principles Checklist confirming conformity with Indian standards
- Risk Management File documenting identification and mitigation of device risks, per the risk management best practices
- Test Reports from approved laboratories
- Labels, Instructions for Use (IFU), and Packaging Details
- Quality Management System (QMS) documentation, commonly ISO 13485:2016
Import License Process (MD15) for Airway Pressure / Oxygen Monitor
For companies intending to import this Class B device:
- No Test License Required: Unlike manufacturing, test license is not mandatory for import.
- Application Submission: Apply on the CDSCO MD Online Portal, submitting Form MD14.
- Documentation Review: Submit comprehensive documents including:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
- Query Resolution: Respond to any queries from CDSCO promptly.
- License Grant: Typically takes 5 to 6 months.
Import License Documents Required
- Manufacturing License from the manufacturer’s country
- Free Sale Certificate indicating product approval in that country
- ISO 13485:2016 Certification
- CE Certificate or equivalent quality mark
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Timeline | Description |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Mandatory for manufacturing applicants |
| MD5 Manufacturing License (Class B) | 3 – 4 months | Includes test license, testing, audit, and final approval |
| MD15 Import License | 5 – 6 months | For importing Class B devices |
Timelines may vary depending on document completeness, audit scheduling, and query resolution speed.
Government Fees and Costs
- MD5 License (Manufacturing Class B):
- Application fee: INR 5,000
- Per product fee: INR 500
- MD15 License (Import Class B):
- Site fee: USD 2,000
- Per product fee: USD 1,000
Additional costs include notified body audit fees, testing laboratory charges, and consultancy fees if external support is engaged.
Common Challenges and Practical Solutions
- Delayed Test Reports: Opt for government-approved labs with shorter turnaround times. Early booking is key.
- Incomplete Documentation: Utilize our Device Master File and Plant Master File guides to ensure comprehensive submissions.
- Audit Non-Compliance: Conduct internal pre-audit checks and engage experienced notified bodies listed on the CDSCO portal.
- Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for devices like the Airway Pressure / Oxygen Monitor. Our consultancy has a proven track record of streamlining applications, minimizing rejections, and expediting approvals. We provide tailored support including documentation preparation, audit readiness, and liaison with CDSCO officials.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class B status using resources such as the Medical Device Classification guide.
- Prepare Documentation: Begin compiling your Device and Plant Master Files, Risk Management File, and other required documents.
- Apply for Test License (MD13): Submit the test license application via the CDSCO MD Online Portal.
- Schedule Product Testing: Engage approved laboratories early to avoid delays.
- Plan for Audit: Contact notified bodies from the official list to schedule your manufacturing site audit.
- Submit MD5 Application: Once test reports and audit readiness are complete, apply for the MD5 license.
Engaging with an experienced regulatory consultant can significantly reduce processing time and avoid common pitfalls. Contact us today to initiate your CDSCO licensing journey for your Airway Pressure / Oxygen Monitor and ensure seamless market entry in India.
