CDSCO License for Airway protection face mask
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 flexible, form-shaped device that is placed over the nose and mouth to provide respiratory protection.
Comprehensive Guide to CDSCO Licensing for Airway Protection Face Masks (Class A Medical Device)
Manufacturers and importers of airway protection face masks—a critical device in anesthesiology designed to provide respiratory protection—must comply with the Central Drugs Standard Control Organization (CDSCO) regulations to legally market their product in India. Given the device's classification as Class A (low risk) under the CDSCO framework, obtaining the appropriate manufacturing or import license is essential to ensure adherence to quality, safety, and regulatory standards.
With over 25 years of regulatory consulting experience and having assisted more than 500 companies in navigating CDSCO licenses, we provide you with an in-depth, step-by-step guide tailored specifically for airway protection face masks.
CDSCO Regulatory Framework for Airway Protection Face Masks
Airway protection face masks fall under the anesthesiology category and are classified as Class A medical devices according to CDSCO Notification 29/Misc/03/2020-DC(177) dated 12.07.2021. Class A devices are considered low risk and are regulated primarily by the State Licensing Authority.
Compliance with the Essential Principles of Safety and Performance, quality management systems (QMS), and documentation requirements are mandatory. The licensing process ensures that devices meet Indian standards and are safe for healthcare use.
For Class A devices, the key license is the MD5 Manufacturing License, which allows manufacturers to produce these devices in India.
Risk Classification and License Requirements
| Device Name | Risk Class | Licensing Authority | License Form | Processing Time | Fee Structure |
|---|---|---|---|---|---|
| Airway Protection Face Mask | Class A | State Licensing Authority | MD5 (MD3) | 3-4 months | Rs 5,000 + Rs 500 per product |
Since airway protection face masks are Class A devices, they require an MD5 license for manufacturing. Importers will require an MD15 import license granted by the Central Licensing Authority.
Manufacturing License Process for Airway Protection Face Masks (MD5 License)
The MD5 manufacturing license process for Class A devices involves several critical steps:
Test License Application (Form MD13): Initially, the manufacturer must apply for a Test License, which authorizes the production of samples for testing. This process takes approximately 1.5 to 2 months.
Product Testing: Samples produced under the test license must be tested at government-approved laboratories to ensure compliance with Indian standards. Refer to the Testing Laboratories list for authorized labs.
Documentation Preparation: Prepare comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, risk management files, and product labeling.
Application Submission: Submit the application for MD5 manufacturing license on Form MD3 via the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit of manufacturing premises and QMS by a notified body is conducted. Manufacturers can check the list of notified bodies for authorized auditors.
Query Resolution: Address any queries raised by the CDSCO department or notified body promptly.
Grant of License: Upon satisfactory completion of the audit and verification, the State Licensing Authority grants the MD5 license on Form MD5.
Manufacturing License Documents Required for Airway Protection Face Masks
Accurate and complete documentation is crucial for a smooth licensing process. For MD5 license applications, manufacturers must provide:
- Company constitution documents (e.g., Memorandum of Association, Articles of Association)
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of the technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing the device design, specifications, and manufacturing process (Learn more about DMF)
- Plant Master File (PMF) documenting manufacturing infrastructure and quality controls (Plant Master File guide)
- Essential Principles Checklist confirming compliance with safety and performance standards
- Risk Management File outlining hazard analysis and mitigation measures (Risk Management essentials)
- Product testing reports from government-approved labs
- Labels and Instructions for Use (IFU) complying with CDSCO labeling requirements
- Quality Management System documentation (e.g., ISO 13485:2016 certificate, SOPs)
Practical Tip: Early preparation of these documents and conducting internal audits prior to submission can significantly reduce review time and avoid delays.
Import License Process for Airway Protection Face Masks (MD15 License)
If you plan to import airway protection face masks into India, you need to obtain an MD15 import license from the Central Licensing Authority. The process is as follows:
Document Compilation: Gather necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, company constitution, and wholesale license.
Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.
Review and Queries: The CDSCO reviews the application and may raise queries.
License Grant: After satisfactory evaluation and query resolution, the MD15 license is granted.
Note: The import license process typically takes 5-6 months.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license in India
- Company constitution documents
Fees for import license vary based on device class; for Class A devices, fees are approximately 50 per product.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Documentation Preparation | 2 to 4 weeks |
| Application Submission | Immediate upon document readiness |
| Audit by Notified Body | 4 to 6 weeks |
| Query Resolution | 2 to 4 weeks |
| License Grant (MD5) | Total approx. 3 to 4 months |
Planning your timeline with these realistic durations in mind will help avoid surprises.
Government Fees and Costs
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- Test License (MD13): Included in the above process
- Product Testing: Variable, depending on laboratory fees (generally Rs 20,000 to Rs 50,000 per product)
- Audit Fees: Paid to the notified body, typically Rs 50,000 to Rs 1,00,000 depending on scope
Budgeting for these costs upfront can prevent financial bottlenecks during the application process.
Common Challenges and Solutions
Incomplete Documentation: Ensure all documents are current, correctly formatted, and signed by authorized personnel. Use our Device Master File guide to avoid common pitfalls.
Delays in Test Lab Approval: Select government-approved labs early and schedule testing promptly.
Audit Non-Compliance: Conduct internal audits and pre-assessments before notified body visits.
Query Management: Respond comprehensively and promptly to CDSCO queries to prevent processing delays.
Our regulatory consulting experience has repeatedly shown that proactive preparation and professional guidance reduce the risk of setbacks.
Expert Consultation and Support
Navigating CDSCO licensing for airway protection face masks can be complex. With 25+ years of experience and over 500 successful client projects, we offer tailored consulting services including:
- Gap analysis and readiness assessment
- Documentation preparation and review
- Coordination with testing labs and notified bodies
- Application filing and follow-up
- Query resolution support
Engaging expert consultants early in the process ensures compliance and accelerates your time to market.
Getting Started with Your CDSCO License Application
To initiate your journey toward CDSCO approval for airway protection face masks:
- Register your organization on the CDSCO MD Online Portal.
- Compile all required documents, focusing on Device Master File and Plant Master File completeness.
- Apply for the Test License (Form MD13) immediately to commence product testing.
- Coordinate with a notified body early to schedule your audit.
- Maintain open communication with CDSCO officials and respond promptly to any queries.
Taking these actionable steps will position your manufacturing or import business for successful regulatory approval in India’s growing medical device market.
For personalized assistance or to discuss your specific case, contact us today. Our dedicated team will guide you through every stage from documentation to license grant, ensuring you meet all regulatory requirements with confidence.
