CDSCO License for Aerosol face mask

Introduction to Aerosol Face Mask and Its Regulatory Importance

Aerosol face masks serve a critical role in anesthesiology by delivering oxygen or air mixed with aerosolized particles directly to a patient’s airway. As a flexible, form-shaped device placed over the nose and mouth, these masks require stringent quality and safety controls. Given their direct interaction with patient respiratory systems, regulatory oversight by CDSCO (Central Drugs Standard Control Organization) is essential to ensure efficacy and safety. With over 25 years of experience and having supported 500+ companies, we understand the nuances and challenges manufacturers face when securing CDSCO licenses for such devices.

CDSCO Regulatory Framework for Aerosol Face Masks

Aerosol face masks fall under the medical device category regulated by the CDSCO. The regulatory framework mandates compliance with the Medical Device Rules (MDR) 2017 and subsequent amendments. As a Class B device (low to moderate risk), aerosol face masks require a manufacturing license under the MD5 category, which is granted by the State Licensing Authority. Importers must secure an MD15 import license from the Central Licensing Authority.

Risk Classification and License Requirements

• Risk Class: B (Low to Moderate Risk)
• License Type for Manufacturing: MD5 License (Application Form MD3)
• License Authority: State Licensing Authority
• Timeline: Approximately 3-4 months for the entire process
• Fees: ₹5,000 per application + ₹500 per product

The classification as Class B means that the device must undergo product testing, documentation audits, and site inspections before license approval.

Manufacturing License Process (MD5)

The MD5 licensing process for aerosol face masks involves multiple steps:

1. Test License Application (Form MD13): Initially, manufacturers must apply for a test license, which typically takes 1.5 to 2 months to obtain. This permits product testing in CDSCO-approved laboratories.

2. Product Testing: Samples of the aerosol face mask must be tested at government-approved labs to verify compliance with applicable standards. Refer to the list of testing laboratories recognized by CDSCO.

3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.

4. License Application (Form MD3): Submit the manufacturing license application on the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will perform a site audit to verify compliance. You can consult the list of notified bodies authorized for Class B device audits.

6. Queries Resolution: Address any queries or deficiencies raised by the licensing authority or notified body.

7. Grant of License: Upon satisfactory compliance, the MD5 license will be issued.

Manufacturing License Documents Required

For the aerosol face mask manufacturing license, prepare the following documents:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of ownership/lease of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board Clearance (NOC)
• Device Master File (DMF) detailing design, materials, and specifications (Device Master File Guide)
• Plant Master File outlining manufacturing processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File demonstrating risk assessment and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certified

Import License Process (MD15)

For importers of aerosol face masks, the MD15 license is mandatory. This license is granted by the Central Licensing Authority and involves the following steps:

1. Document Preparation: Assemble necessary documents such as manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certificate, CE certificate if applicable, Device and Plant Master Files.

2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.

3. Queries Resolution: Respond to any requests or clarifications issued by CDSCO.

4. License Grant: After successful verification, the import license (MD15) is issued.

Typical Timeline: About 5-6 months.

Fees: Varies by risk class; for Class B devices, fees are approximately $2000 per site and$1000 per product.

For detailed guidance, see our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD5 License: ₹5,000 per application + ₹500 per product
• Test License (MD13): Included in the MD5 process; nominal fees apply

Additional costs may include testing fees at government-approved labs and audit fees charged by notified bodies.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or incorrect documents. We recommend a thorough pre-application audit to ensure all files, especially Device and Plant Master Files, comply with CDSCO norms.

• Delays in Product Testing: Testing laboratories can have backlogs. Early submission of samples and selecting labs strategically can mitigate this risk.

• Audit Non-Compliance: Site audits often uncover gaps in QMS or infrastructure. Conduct mock audits prior to the official visit to address potential issues.

• Query Resolution Delays: Prompt and precise responses to CDSCO queries are vital. Maintain a dedicated regulatory point of contact to accelerate this process.

Expert Consultation and Support

With over 25 years in regulatory consulting, we have guided over 500 manufacturers and importers through the CDSCO licensing maze. Our services include:

• Comprehensive gap analysis and documentation review
• Assistance with Device and Plant Master File preparation
• Coordination with notified bodies and testing laboratories
• End-to-end application filing and follow-up

Our deep understanding of CDSCO’s expectations helps avoid common pitfalls and expedites approvals.

Getting Started with Your CDSCO License Application

To begin your journey toward obtaining the MD5 manufacturing license for aerosol face masks:

1. Assess Your Product Class: Confirm your device’s Class B status using the Medical Device Classification resource.

2. Prepare Test Samples: Arrange for product testing at CDSCO-recognized labs.

3. Compile Documentation: Utilize our Device Master File and Plant Master File guides to assemble compliant files.

4. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.

5. Engage a Notified Body: Schedule your audit by selecting from the CDSCO notified bodies authorized for Class B devices.

6. Submit MD5 Application: Once testing and audit are complete, file Form MD3 for manufacturing license approval.

By following these actionable steps and leveraging expert support, you can navigate the regulatory pathway efficiently and bring your aerosol face mask to the Indian market with confidence.