CDSCO License for Exhaled-gas oesophageal intubation detector

Introduction to Exhaled-gas Oesophageal Intubation Detector and Regulatory Importance

The Exhaled-gas oesophageal intubation detector is a critical medical device designed for respiratory management, specifically to verify correct placement of endotracheal (ET) tubes by assessing exhaled CO2 levels. This device plays a pivotal role in airway management by preventing incorrect intubation, which can lead to serious patient complications. Given its importance in clinical settings, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is essential for any manufacturer or importer aiming to market this device in India.

With the notification File No. 29/Misc/03/2020-DC(197) dated 6.8.2021, this device is classified under Risk Class A, requiring adherence to the specific regulatory framework set by CDSCO for low-risk medical devices.

CDSCO Regulatory Framework for Exhaled-gas Oesophageal Intubation Detector

Under the Medical Device Rules, 2017, the Exhaled-gas oesophageal intubation detector falls into Class A, which is considered low risk. CDSCO mandates that manufacturers obtain a manufacturing license (MD5) issued by the State Licensing Authority. Importers, on the other hand, must secure an import license (MD15) from the Central Licensing Authority.

This regulatory framework ensures device safety, efficacy, and quality through a structured process involving documentation, testing, and audits.

Risk Classification and License Requirements for Class A Devices

Class A devices like the Exhaled-gas oesophageal intubation detector are subject to the MD5 license process:

• License Type: MD5 Manufacturing License
• Application Form: MD3
• Issuing Authority: State Licensing Authority
• Total Processing Time: Approximately 3-4 months
• Test License: Required (Form MD13)
• Government Fees: ₹5,000 per application + ₹500 per product

For detailed classification guidance, you can visit our Medical Device Classification resource.

Manufacturing License Process (MD5) for Class A Devices

Step 1: Obtain Test License (MD13)

Before applying for the MD5 license, manufacturers must obtain a Test License (Form MD13). This license permits product testing from CDSCO-approved laboratories. The test license process generally takes 1.5 to 2 months.

Step 2: Product Testing

The device must undergo testing at government-approved laboratories to confirm compliance with Indian standards. You can check the list of Testing Laboratories authorized by CDSCO.

Step 3: Document Preparation

Prepare the complete set of documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.

Step 4: Application Submission

Submit the application for the MD5 license using Form MD3 through the CDSCO MD Online Portal.

Step 5: Audit by Notified Body

An audit by an accredited notified body is mandatory. Check the list of notified bodies to select your auditor.

Step 6: Query Resolution

Respond promptly to any queries raised by the department or the notified body to avoid delays.

Step 7: License Grant

Upon satisfactory review and audit, the State Licensing Authority will issue the MD5 license on Form MD5.

For a comprehensive walkthrough, refer to our MD5 License Guide.

Manufacturing License Documents Required for Exhaled-gas Oesophageal Intubation Detector

• Company Constitution (Certificate of Incorporation/Registration)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC (No Objection Certificate)
• Pollution Control Board NOC
• Device Master File (DMF) – detailing device design, specifications, and compliance
• Plant Master File (PMF) – manufacturing site details and processes
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File with hazard analysis and mitigation strategies
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation including SOPs and CAPA procedures

Our Device Master File Guide and Plant Master File Guide offer detailed insights into preparing these documents.

Import License Process (MD15) for the Device

For importers wishing to bring the Exhaled-gas oesophageal intubation detector into India, obtaining an MD15 import license from the Central Licensing Authority is mandatory.

Key Steps:

• Prepare required documents including Manufacturing License, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and Wholesale License.
• Submit application via Form MD14 on the CDSCO MD Online Portal.
• Address any queries from CDSCO promptly.
• Await license issuance (Form MD15).

Typical processing time is 5-6 months. For detailed procedures, see our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate demonstrating marketing approval
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution documents

Timeline and Processing Duration

Planning ahead is crucial to meet market launch deadlines, especially considering testing and audit schedules.

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product
• Test License Fee (MD13): Included in above or separate nominal fees depending on state
• Audit Fees: Payable to the notified body as per their schedule (typically ₹25,000–₹50,000)

Budgeting realistically for these fees plus costs related to lab testing and documentation preparation is essential.

Common Challenges and Solutions

Challenge 1: Delays in Test License and Product Testing

• Solution: Engage with CDSCO early and select accredited testing labs with shorter backlogs.

Challenge 2: Incomplete Documentation Leading to Query Backlogs

• Solution: Utilize expert regulatory consultants to review documents before submission.

Challenge 3: Audit Non-compliance Issues

• Solution: Conduct mock audits and implement robust QMS to ensure readiness.

Challenge 4: Misclassification of Device Risk Class

• Solution: Verify classification using official resources to avoid incorrect application forms and authority.

Expert Consultation and Support

With over 25 years of experience and a track record of successfully assisting 500+ companies, we provide end-to-end regulatory support including:

• Device classification and regulatory pathway analysis
• Preparation of Device and Plant Master Files
• Assistance with test license and product testing coordination
• Application filing and audit support
• Query management and compliance assurance

Reach out to our team to streamline your CDSCO licensing process and reduce time-to-market.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class A under CDSCO guidelines.
2. Prepare Your Documents: Start compiling key documents such as the Device Master File, Plant Master File, and QMS records.
3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal to initiate testing.
4. Schedule Testing: Coordinate with CDSCO-approved labs for timely product testing.
5. Engage a Notified Body: Select and schedule an audit with an accredited body from the Notified Bodies List.
6. Submit Manufacturing License Application (MD5): Once testing and audit are complete, apply for the MD5 license.
7. Prepare for Queries: Monitor application status and respond promptly to any queries.

By following these steps with expert guidance, you can efficiently navigate the regulatory landscape for your Exhaled-gas oesophageal intubation detector and successfully launch in the Indian market.