CDSCO License for Venturi oxygen face mask
Medical Device Information
Intended Use
A device designed to be placed over the nose and mouth of a patient to deliver a near-precise mixture of air and oxygen (O2) to a patient airway without the use of a gas mixer.
Comprehensive Guide to CDSCO Licensing for Venturi Oxygen Face Mask (Class B Medical Device)
Venturi oxygen face masks are critical anesthesiology devices designed to deliver a precise oxygen-air mixture to patients without requiring a gas mixer. Given their vital role in respiratory therapy, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) framework is mandatory to manufacture or import these devices in India. With over 25 years of experience assisting 500+ manufacturers and importers, we provide you an expert roadmap for obtaining the necessary CDSCO licenses specific to your Venturi oxygen face mask, classified as a Class B medical device.
CDSCO Regulatory Framework for Venturi Oxygen Face Mask
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, which align with global standards to ensure safety, efficacy, and quality. The Venturi oxygen face mask falls under Class B (Low-Moderate risk) devices per Notification 29/Misc/03/2020-DC(177), dated 12.07.2021.
Manufacturers of Class B devices must obtain an MD5 manufacturing license granted by the State Licensing Authority. Importers require an MD15 import license from the Central Licensing Authority. Compliance includes quality management system adherence (ISO 13485), device testing, and audit by a notified body.
For detailed classification criteria, refer to our Medical Device Classification guide.
Risk Classification and License Requirements for Venturi Oxygen Face Mask
- Risk Class: B (Low-Moderate risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Testing: Required via government-approved laboratories
- Audit: Conducted by CDSCO notified bodies
This classification mandates a structured process including test license acquisition (MD13), product testing, documentation, audit, and final license issuance.
Manufacturing License Process (MD5) for Class B Devices
Apply for Test License (Form MD13): Before manufacturing, apply for a test license to produce samples for testing. This step typically takes about 1.5 to 2 months.
Product Testing: Submit the Venturi oxygen face mask samples to government-approved testing laboratories for performance and safety evaluation. Refer to the List of Testing Laboratories.
Documentation Preparation: Compile all mandatory documentation, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and QMS documents.
Apply for Manufacturing License (Form MD3): Submit the complete application on the CDSCO MD Online Portal along with fees.
Audit by Notified Body: A notified body will conduct a thorough audit of your manufacturing facility and documentation. Check the List of Notified Bodies for authorized auditors.
Resolution of Queries: Address any queries raised by CDSCO or the notified body promptly to avoid delays.
Grant of License (Form MD5): Upon successful audit and verification, the State Licensing Authority issues the manufacturing license.
For an in-depth walkthrough, consult our detailed MD5 License Guide.
Manufacturing License Documents Required for Venturi Oxygen Face Mask
To ensure your MD5 application is flawless, prepare the following documents meticulously:
- Company constitution and registration proof
- Proof of ownership or lease of manufacturing premises
- Technical staff qualifications and experience
- Fire safety NOC from local fire department
- Pollution control board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Guide here)
- Plant Master File (PMF) including facility layout and equipment (Guide here)
- Essential Principles Checklist confirming compliance with MDR 2017
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Product test reports from government-approved labs
- Labeling and Instructions for Use (IFU) complying with CDSCO guidelines
- Quality Management System (QMS) documentation, preferably ISO 13485 certification
Attention to detail in these documents reduces the likelihood of audit observations and accelerates license grant.
Import License Process (MD15) for Venturi Oxygen Face Mask
For importers intending to bring Venturi oxygen face masks into India, an MD15 license from the Central Licensing Authority is mandatory. The procedure is as follows:
Document Preparation: Collect all relevant documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF and PMF, wholesale license, and company constitution.
Application Submission: File the application through the CDSCO MD Online Portal using Form MD14.
Queries and Clarifications: Respond promptly to any departmental queries.
License Issuance: Upon successful review, the MD15 import license is granted.
Our comprehensive Import License Guide offers valuable insights to streamline this process.
Import License Documents Required for Venturi Oxygen Face Mask
- Valid manufacturing license from the country of origin
- Free Sale Certificate (FSC) or equivalent
- ISO 13485:2016 Quality Management System certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale license for distribution
- Company constitution and registration proof
Ensuring completeness and accuracy of these documents helps avoid application rejections and procedural delays.
Timeline and Processing Duration
| License Type | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Manufacturing License (MD5) | 3 to 4 months including audit |
| Import License (MD15) | 5 to 6 months |
For Venturi oxygen face masks, expect a total of 4 to 6 months from initial application to license grant when manufacturing and importing.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B) | Rs. 5,000 | Rs. 500 |
| MD15 (Import) | Rs. 2,000 (Class B site) | Rs. 1,000 |
Additional costs include:
- Testing fees charged by authorized laboratories
- Audit fees payable to notified bodies
- Consultancy and documentation preparation fees (if outsourced)
Budgeting accurately for these helps in financial planning and avoiding unexpected expenses.
Common Challenges and Solutions in Licensing Venturi Oxygen Face Mask
- Delayed Testing Results: Government labs may have backlogs; plan submissions early and consider multiple approved labs.
- Incomplete Documentation: Use checklists and expert review to ensure all documents meet CDSCO standards.
- Audit Non-Compliance: Conduct pre-audit internal assessments to identify gaps.
- Query Resolution Delays: Assign dedicated personnel to promptly address regulatory queries.
Our hands-on experience enables us to anticipate such issues and provide proactive solutions.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Leveraging expert consultants with extensive regulatory knowledge, like our team with 25+ years of experience, can:
- Ensure compliant and complete documentation
- Coordinate with notified bodies and testing labs
- Expedite application preparation and submission
- Provide training on post-license compliance
Our proven track record with over 500 successful client approvals positions us as your trusted partner.
Getting Started with Your CDSCO License Application for Venturi Oxygen Face Mask
Assess Your Device Classification: Confirm your device is Class B as per CDSCO.
Prepare Initial Documents: Focus on obtaining company registration, premises proof, and technical staff qualifications.
Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal.
Identify Testing Laboratories: Select a government-approved lab from the Testing Laboratories list.
Develop Device and Plant Master Files: Use our detailed guides for DMF and PMF.
Plan Audit Preparation: Engage a notified body early by consulting the Notified Bodies List.
Budget Accordingly: Allocate funds for fees, testing, audits, and consultancy.
Seek Expert Assistance: Contact experienced consultants to streamline your licensing journey.
Taking these practical steps will set a solid foundation for timely CDSCO approval of your Venturi oxygen face mask, enabling market entry and compliance assurance.
For personalized support and end-to-end assistance, reach out to our regulatory experts today and leverage our quarter-century expertise to accelerate your regulatory success.
