CDSCO License for Exhaled-gas oesophageal intubation detector, 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 designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. It is used during paediatric intubation and is attached between the ET tube and the breathing device. It typically functions through colorimetric CO2 detection using an indicator paper that changes colour. A colour chart (e.g., attached to the device) permits interpretation into approximate CO2 concentration. It is used in healthcare facilities or in the field to evaluate oesophageal intubation, which if performed incorrectly, prevents patient ventilation. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Paediatric Exhaled-Gas Oesophageal Intubation Detectors (Class A)
Medical devices designed for critical pediatric applications such as the exhaled-gas oesophageal intubation detector play a vital role in ensuring patient safety during airway management. This device, intended to verify correct endotracheal (ET) tube placement by detecting exhaled CO2 levels, is classified as a Class A medical device under the Indian regulatory framework. Complying with the Central Drugs Standard Control Organisation (CDSCO) regulations is essential for manufacturers and importers aiming to market this life-saving device in India.
CDSCO Regulatory Framework for Paediatric Exhaled-Gas Oesophageal Intubation Detectors
In India, medical devices are regulated under the Medical Device Rules, 2017, enforced by CDSCO. Devices like the exhaled-gas oesophageal intubation detector, used in pediatrics and neonatal care, fall under Class A due to their low risk profile. This classification determines the licensing pathway, compliance requirements, and approval authorities.
Risk Classification and License Requirements for Class A Devices
Class A devices are considered low risk and require a manufacturing license known as the MD5 license, issued by the State Licensing Authority. The exhaled-gas oesophageal intubation detector, being single-use and essential for confirming ET tube placement, fits this category.
- License Type: MD5 (Application Form MD3)
- Issuing Authority: State Licensing Authority
- Typical Processing Time: 3-4 months
- Fees: Rs 5,000 per application + Rs 500 per product
Understanding this framework helps manufacturers and importers plan their regulatory submissions effectively.
Step-by-Step Manufacturing License Process (MD5) for Your Device
- Test License Application (Form MD13): Initially, a test license must be secured; this permits product testing necessary for license approval. The test license process typically takes 1.5 to 2 months.
- Product Testing: Testing must be conducted at CDSCO-approved laboratories. These tests verify safety and efficacy based on device specifications. You can find the list of approved testing laboratories on the CDSCO portal.
- Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
- License Application Submission: Submit the manufacturing license application (Form MD3) via the CDSCO MD Online Portal.
- Audit by Notified Bodies: An audit by a notified body is mandatory. Refer to the notified bodies list to select an authorized auditor.
- Resolution of Queries: Address any queries raised by CDSCO or the notified body promptly to avoid delays.
- Grant of License: Upon satisfactory review and audit, the MD5 license is granted (Form MD5).
Essential Documents Required for MD5 License Application
For the exhaled-gas oesophageal intubation detector, manufacturers must submit the following:
- Company Constitution Documents: Proof of legal entity (e.g., incorporation certificate)
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Credentials: Qualifications and experience details
- Fire NOC and Pollution Control NOC: Compliance with safety and environmental norms
- Device Master File: Detailed device specifications, design, and manufacturing process (Device Master File Guide)
- Plant Master File: Details of manufacturing facility and processes (Plant Master File Guide)
- Essential Principles Checklist: Compliance with Indian Medical Device Rules
- Risk Management File: Risk assessment and mitigation strategies (Risk Management)
- Test Reports: From CDSCO-approved labs
- Labeling and Instructions for Use (IFU): Clear instructions and safety information
- Quality Management System Documents: Typically ISO 13485 certification or equivalent
Import License Process (MD15) for Paediatric Intubation Detectors
If you plan to import this device, an MD15 import license issued by the Central Licensing Authority is required. The process involves:
- Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE Certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution documents.
- License Application Submission: Apply through Form MD14 on the CDSCO MD Online Portal.
- Review and Queries: CDSCO reviews the application and may raise queries.
- License Grant: Upon satisfactory compliance, the MD15 license is issued.
Typical timeline: 5-6 months.
Government fees: Varies by device class but for Class A devices, approximately 50 per product.
For more detailed guidance, consult our Import License Guide.
Timeline and Processing Duration
| Process Step | Timeline |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| License Application (MD5) | Immediate after documents ready |
| Audit and Inspection | 4 – 6 weeks |
| Query Resolution and Approval | 2 – 4 weeks |
| Total Estimated Time | 3 – 4 months |
Planning your regulatory submission with these timelines in mind ensures smoother market entry.
Government Fees and Costs Breakdown
- Test License Fee (MD13): Rs 5,000
- Manufacturing License Fee (MD5): Rs 5,000 per application
- Per Product Fee: Rs 500 per product
- Audit Fees: Varies by notified body; typically Rs 50,000 to Rs 1,00,000 depending on scope
Budgeting for these costs early in the development cycle avoids unexpected financial hurdles.
Common Challenges and Practical Solutions
- Delayed Testing Results: Engage early with accredited testing labs and understand their capacity.
- Incomplete Documentation: Use checklists and expert consultation to ensure all required files like Device Master File and Risk Management File are comprehensive.
- Audit Non-Conformities: Conduct internal pre-audit reviews and training for your technical staff to meet notified body expectations.
- Query Resolution Delays: Assign a dedicated regulatory liaison to manage communications with CDSCO.
Expert Consultation and Support
With over 25 years of experience and 500+ clients successfully licensed, we offer tailored advisory services for your paediatric exhaled-gas oesophageal intubation detector. Our expertise covers:
- Regulatory pathway mapping
- Documentation preparation and review
- Coordination with notified bodies and testing labs
- Post-approval compliance audits
Contact us early to streamline your application and mitigate regulatory risks.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm Class A risk status to determine MD5 licensing requirements.
- Prepare Your Test License Application: Initiate Form MD13 submission through the CDSCO MD Online Portal.
- Identify Testing Laboratories: Select from CDSCO-approved labs for product testing.
- Compile Required Documentation: Utilize our Device Master File Guide and Plant Master File Guide for accurate documentation.
- Schedule Notified Body Audit: Initiate contacts early with notified bodies per the notified bodies list.
- Submit Manufacturing License Application (Form MD3): Once testing and documentation are ready, submit your application via the online portal.
Starting with these concrete steps will position your paediatric exhaled-gas oesophageal intubation detector for timely CDSCO approval and successful entry into the Indian healthcare market.
