CDSCO License for Manual jet ventilation device

Comprehensive Guide to CDSCO MD9 License for Manual Jet Ventilation Device (Class C Anesthesiology Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully supported 500+ companies in securing CDSCO licenses, we understand the critical nuances involved in obtaining the necessary approvals for complex medical devices like the Manual Jet Ventilation Device. This Class C anesthesiology device plays a vital role in emergency airway management, and compliance with the Central Drugs Standard Control Organization (CDSCO) regulations is mandatory to legally manufacture or import such devices within India.

Understanding the Manual Jet Ventilation Device and Its Regulatory Importance

The Manual Jet Ventilation Device is a portable, manually-operated, noninvasive device used with compressed oxygen and airway access tools for transtracheal ventilation during emergencies involving partial or complete airway obstruction. Given its critical use in life-saving procedures, it is classified as a Class C device under the CDSCO risk classification system — indicating a moderate to high risk.

Ensuring timely and compliant regulatory approval not only guarantees patient safety but also opens up access to the Indian medical device market, which continues to grow rapidly.

CDSCO Regulatory Framework for Manual Jet Ventilation Devices

The CDSCO governs medical device approvals through a risk-based classification system. For Class C devices such as the Manual Jet Ventilation Device, the Central Licensing Authority handles licensing and compliance oversight. The key regulatory pathway involves obtaining an MD9 Manufacturing License (if manufacturing locally) or an MD15 Import License (if importing).

You must comply with guidelines under the Medical Device Rules, 2017, and submit your applications through the CDSCO MD Online Portal.

Risk Classification and License Requirements

• Device Name: Manual Jet Ventilation Device
• Risk Class: C (Moderate-High Risk)
• Category: Anesthesiology
• License Type: MD9 Manufacturing License (for local manufacturers)
• Relevant Notification: 29/Misc/03/2020-DC(177), dated 12.07.2021

Manufacturing License Process for Class C Devices (MD9 License)

The MD9 license process is comprehensive and involves multiple key stages:

1. Test License Application (Form MD13): The first step is obtaining a test license, which allows initial production of devices for testing.
2. Product Testing: Conduct product testing at CDSCO-approved government laboratories. You can find the list of Testing Laboratories here.
3. Document Preparation: Prepare a complete dossier including Device Master File (DMF), Plant Master File (PMF), risk management files, essential principles checklist, and quality management system (QMS) documentation.
4. Main License Application (Form MD7): Submit the manufacturing license application with all required documents.
5. Regulatory Audit: CDSCO inspectors will conduct a thorough audit of the manufacturing facility and QMS.
6. Query Resolution: Respond promptly to any queries raised during the audit.
7. License Grant: On successful compliance, the MD9 license is granted.

For detailed guidance, refer to our MD9 License Guide.

Manufacturing License Documents Required for Manual Jet Ventilation Device

• Company Constitution Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience Documents
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing process documentation — see our Device Master File guide
• Plant Master File (PMF): Details on the manufacturing environment and processes — refer to our Plant Master File guide
• Essential Principles Checklist
• Risk Management File: Per ISO 14971 standards — learn more about Risk Management
• Product Testing Reports from Approved Labs
• Labels, Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process for Manual Jet Ventilation Device (MD15 License)

If you are importing the Manual Jet Ventilation Device into India, you must apply for an MD15 import license through the Central Licensing Authority. The process is as follows:

1. Document Preparation: Collate manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate or equivalent, DMF, PMF, wholesale license, and company constitution.
2. Application Submission (Form MD14): Submit the import license application through the CDSCO MD Online Portal.
3. Query Resolution: Respond to any queries raised by the department swiftly.
4. License Grant: Upon successful review, the MD15 license is issued.

For a detailed step-wise guide, check our Import License Guide.

Import License Documents Required

• Valid Manufacturer’s License (equivalent to MD9) from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent international certification
• Device Master File
• Plant Master File
• Wholesale License for importers
• Company Constitution Documents

Timeline and Processing Duration

• MD9 Manufacturing License: 4-5 months total

  • Test License (MD13): 1.5-2 months
  • Product Testing: 1 month
  • Document preparation and submission: 1 month
  • Regulatory audit & query resolution: 1-1.5 months

• MD15 Import License: Approximately 5-6 months

  • Document preparation & application submission: 1-2 months
  • Review and query resolution: 3-4 months

Government Fees and Costs

• MD9 License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• MD15 Import License Fees (varies by class):

  • Class C Devices: ₹3,000 per site + ₹1,500 per product

Note: Additional costs include product testing fees charged by government-approved labs, notified body audit fees, and consultancy fees if using expert services.

Common Challenges and Practical Solutions

• Delays in Product Testing: Plan testing well in advance and select labs from the CDSCO approved list to avoid delays.
• Incomplete Documentation: Use our comprehensive checklists to ensure the Device Master File, Plant Master File, and risk management files are complete and compliant.
• Audit Non-Compliance: Conduct pre-audit internal assessments and gap analyses to prepare for CDSCO inspections.
• Regulatory Query Backlogs: Maintain responsive communication channels and document clarifications promptly.
• Understanding Device Classification: Double-check device classification to avoid applying for incorrect licenses by reviewing the Medical Device Classification.

Expert Consultation and Support

Navigating CDSCO’s regulatory landscape for Class C devices like the Manual Jet Ventilation Device can be complex. Our team offers tailored consultancy services including dossier preparation, audit readiness, testing coordination, and application handling. Leveraging our 25+ years of expertise ensures your submission is accurate and compliant, significantly reducing approval timelines.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device’s Class C status.
2. Prepare Preliminary Documentation: Gather company credentials, manufacturing details, technical staff information.
3. Apply for Test License (MD13): Initiate test license application on the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs promptly.
5. Assemble Complete Dossier: Compile DMF, PMF, risk management, essential principles, and QMS documentation.
6. Submit Main License Application (MD7) for Manufacturing or (MD14) for Import: Ensure all documents are accurate and complete.
7. Prepare for Audit: Conduct internal audits and remedy gaps.
8. Respond to Queries: Maintain timely and clear communication with CDSCO.

With proactive planning and expert support, obtaining the MD9 manufacturing license or MD15 import license for your Manual Jet Ventilation Device can be a streamlined and successful process.

For personalized assistance and to discuss your specific project requirements, please reach out to our regulatory experts.

Empower your medical device business with compliant, timely CDSCO licensing to serve India's critical healthcare needs.