CDSCO License for Anaesthesia Facemask, reusable (paediatric)

Comprehensive Guide to CDSCO Licensing for Reusable Paediatric Anaesthesia Facemask (Class B)

As a trusted regulatory consultancy with over 25 years' experience and having supported more than 500 companies in securing CDSCO licenses, we understand the nuances and complexities faced by manufacturers and importers of medical devices like the reusable paediatric anaesthesia facemask. This device, classified as Class B under CDSCO regulations, mandates a thorough compliance process to ensure safety and efficacy for its intended use in paediatrics and neonatology.

Understanding the Device and Its Regulatory Importance

The reusable paediatric anaesthesia facemask is a critical medical device designed to administer anaesthetic gases via a flexible, form-fitting cover placed over a child’s nose and mouth. Constructed from sterilizable materials such as PVC or rubber, it ensures an airtight seal, reducing the risk of microbial contamination and particulate intrusion. Given its direct interface with the respiratory tract and paediatric application, regulatory oversight by CDSCO is stringent to ensure patient safety.

CDSCO Regulatory Framework for Reusable Paediatric Anaesthesia Facemasks

This device falls under the Class B risk category according to the CDSCO classification system. Class B devices require a specific manufacturing license called the MD5 license, which is granted by the State Licensing Authority. The regulatory journey involves multiple steps including testing, documentation, audits, and timely communication with authorities.

For clarity on medical device classification and to confirm your device class, refer to our detailed Medical Device Classification guide.

Risk Classification and License Requirements

Manufacturing License Process (MD5)

The MD5 license application process is methodical and requires adherence to CDSCO guidelines:

1. Obtain Test License (Form MD13): Before applying for MD5, manufacturers must secure a test license on Form MD13. This allows product testing at government-approved laboratories and typically takes 1.5 to 2 months.

2. Product Testing: Submit the anaesthesia facemask for testing to ensure compliance with safety and performance standards. You can find a list of CDSCO-approved testing laboratories to facilitate this step.

3. Document Preparation: Compile all required documentation, including Device Master File and Plant Master File.

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

5. Audit by Notified Body: An audit by a CDSCO-recognized notified body is mandatory. Refer to the list of notified bodies authorized to conduct MD5 audits.

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

7. Grant of MD5 License: Upon satisfactory completion of audits and document verification, the State Licensing Authority issues the MD5 manufacturing license.

For an in-depth walkthrough, our MD5 License Guide provides expert insights.

Manufacturing License Documents Required

To streamline your application, ensure you have the following documents ready:

• Company Constitution Documents (Incorporation certificate, partnership deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff involved in manufacturing
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed technical specifications, design, and manufacturing process documentation. Our Device Master File guide can assist in creating a comprehensive DMF.
• Plant Master File (PMF): Documentation of manufacturing facility layout, equipment, and quality systems. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist: Compliance checklist aligned with Indian Medical Device Rules
• Risk Management File: Documentation demonstrating risk assessment and mitigation strategies. Learn more about implementing risk management effectively.
• Test Reports: From CDSCO-approved laboratories validating safety and performance
• Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs

Import License Process (MD15) for Paediatric Anaesthesia Facemask

If you are an importer rather than a manufacturer, the process involves obtaining the MD15 import license issued by the Central Licensing Authority. The process typically spans 5-6 months.

Key steps include:

• Document preparation including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
• Submission of application on the CDSCO MD Online Portal using Form MD14.
• Resolution of queries raised by CDSCO officials.
• Grant of MD15 license.

For detailed import license procedures, check our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 Certification
• CE Certificate or other regulatory approvals
• Detailed Device Master File and Plant Master File
• Wholesale License
• Company constitution and ownership documents

Timeline and Processing Duration

Overall, expect 3 to 4 months from test license application to MD5 license grant.

Government Fees and Costs

• Test License (MD13): Approximately Rs 2000 - Rs 5000 depending on state
• MD5 Manufacturing License Application Fee: Rs 5000 per application
• Product Fee: Rs 500 per product (applicable per product variant)
• Audit and Testing Charges: Variable based on notified body and testing laboratory

Proper budgeting and resource allocation from the outset prevent delays and reapplications.

Common Challenges and Solutions

• Incomplete Documentation: Thoroughly cross-check all required documents against the CDSCO checklist to avoid rejection.
• Delays in Product Testing: Engage with CDSCO-approved testing labs early to schedule tests; avoid last-minute submissions.
• Audit Non-Compliance: Prepare your manufacturing site and QMS in line with notified body expectations; consider pre-audit internal assessments.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO license process for a reusable paediatric anaesthesia facemask can be complex. With over two decades of expertise, we offer tailored consultation services that cover document preparation, audit readiness, and strategic regulatory planning to expedite approvals.

Our hands-on support ensures your application complies fully with CDSCO requirements, minimizing back-and-forth and accelerating market entry.

Getting Started with Your CDSCO License Application

1. Assess your device classification to confirm Class B status.
2. Prepare your technical documentation including Device Master File and Plant Master File.
3. Apply for the test license (MD13) on the CDSCO MD Online Portal.
4. Schedule product testing with an approved laboratory.
5. Compile your application for the MD5 manufacturing license (Form MD3).
6. Engage a notified body early for audit scheduling.
7. Submit your application and track progress via the online portal.

Starting early and partnering with experienced regulatory consultants can significantly reduce your time to market and ensure compliance.

For personalized assistance on your reusable paediatric anaesthesia facemask licensing, contact us today and leverage our proven expertise in CDSCO regulatory affairs.