CDSCO License for Breathing mouthpiece

Comprehensive Guide to CDSCO Licensing for Breathing Mouthpiece (Class A Medical Device)

Introduction: Understanding the Breathing Mouthpiece and Regulatory Importance

The breathing mouthpiece is a Class A medical device designed to be inserted into a patient mouth to facilitate access to the respiratory system, primarily used in anesthesiology procedures. Given its direct application in critical respiratory interventions, regulatory compliance is vital to ensure safety, efficacy, and quality. In India, the Central Drugs Standard Control Organization (CDSCO) governs medical device licensing, and obtaining the correct license is mandatory before manufacturing or importing such devices.

With over 25 years of experience assisting 500+ companies through the CDSCO licensing process, we bring you detailed insights specific to the breathing mouthpiece, helping you navigate regulatory complexities with confidence.

CDSCO Regulatory Framework for Breathing Mouthpiece

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017. Since the breathing mouthpiece falls under anesthesiology devices and has been notified under Notification No. 29/Misc/03/2020-DC(177) dated 12.07.2021, it requires adherence to the prescribed regulatory framework.

For Class A devices like the breathing mouthpiece, licensing is handled primarily by the State Licensing Authority through the MD5 license application process. The framework emphasizes quality systems, product testing, and facility audits to ensure compliance.

Risk Classification and License Requirements

The breathing mouthpiece has been classified as a Class A (low risk) medical device by CDSCO. This classification influences the licensing pathway:

• Class A devices require an MD5 Manufacturing License (Application Form MD3).
• Licensing is granted by the State Licensing Authority.
• The process involves obtaining a Test License (MD13) first, followed by product testing, documentation, and audits.

For manufacturers, this means a relatively streamlined process compared to higher-risk devices but still necessitates thorough preparation.

Manufacturing License Process (MD5) for Breathing Mouthpiece

1. Obtain Test License (Form MD13):

   • Apply for a test license to manufacture the breathing mouthpiece for testing purposes.
   • Duration: Approximately 1.5 to 2 months.

2. Product Testing:

   • Conduct product testing at CDSCO-approved government laboratories.
   • Testing ensures compliance with safety and performance standards.
   • See the list of testing laboratories for approved labs.

3. Prepare Documentation:

   • Compile all required documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. Submit Manufacturing License Application (Form MD3):

   • File the application via the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • An audit of manufacturing premises and QMS is conducted by a notified body.
   • Refer to the list of notified bodies accredited for MD5 audits.

6. Resolve Queries:

   • Address any queries or observations raised by CDSCO or the notified body promptly.

7. License Grant:

   • Upon satisfactory compliance, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required

For the breathing mouthpiece, you must prepare and submit the following:

• Company Constitution Documents (e.g., incorporation certificate, partnership deed)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Comprehensive technical documentation of the breathing mouthpiece. Our Device Master File guide offers detailed insights.
• Plant Master File (PMF): Details of manufacturing facility and processes. Refer to our Plant Master File guide.
• Essential Principles Checklist
• Risk Management File detailing hazard analysis and mitigation strategies. See practical tips in our Risk Management article.
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (preferably ISO 13485 compliant)

Import License Process (MD15) for Breathing Mouthpiece

If you intend to import the breathing mouthpiece into India, you will need an MD15 import license granted by the Central Licensing Authority. The process involves:

1. Document Preparation:

   • Manufacturing license from the country of origin
   • Free Sale Certificate
   • ISO 13485:2016 Certification
   • CE Certificate or equivalent
   • Device and Plant Master Files
   • Wholesale License
   • Company Constitution

2. Application Submission:

   • Apply using Form MD14 on the CDSCO MD Online Portal.

3. Queries Resolution:

   • Address any queries raised by CDSCO promptly.

4. License Grant:

   • The import license (Form MD15) is granted typically within 5-6 months.

Note: For Class A devices, government fees are approximately $1000 per site plus$50 per product.

Timeline and Processing Duration

Timelines may vary depending on completeness of documentation and responsiveness to queries.

Government Fees and Costs

• Test License (MD13): Nominal fees as prescribed by CDSCO.
• MD5 Manufacturing License: Rs. 5000 per application + Rs. 500 per product.
• Additional costs include fees for product testing, notified body audit charges, and any consultant fees if you engage regulatory experts.

Common Challenges and Solutions

• Delayed Test Reports: Testing at government labs can be time-consuming. To mitigate delays, schedule testing early and consider labs with shorter turnaround times.
• Incomplete Documentation: Ensure all files, especially Device Master File and Risk Management File, are comprehensive and compliant.
• Audit Non-Compliance: Prepare your facility and QMS rigorously. Conduct internal audits prior to notified body visits.
• Query Resolution Delays: Respond to CDSCO queries promptly with clear, supported evidence.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially with evolving regulations. With our 25+ years of expertise and over 500 successful client approvals, we offer:

• Tailored consultancy for your breathing mouthpiece licensing.
• Assistance in document preparation and gap analysis.
• Coordination with notified bodies and testing laboratories.
• Training and mock audits to ensure readiness.

Our proven track record helps manufacturers and importers avoid common pitfalls, saving time and costs.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your breathing mouthpiece is Class A as per Medical Device Classification.
2. Gather preliminary documents: Company constitution, premises proof, staff details.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
4. Plan your testing: Engage with government-approved labs early.
5. Prepare technical files: Utilize our Device Master File and Plant Master File guides.
6. Engage with a notified body: Schedule your facility audit.
7. Submit MD5 license application: Once testing and audit are complete, file Form MD3.

Ready to streamline your CDSCO licensing journey for the breathing mouthpiece? Contact us today for expert assistance tailored to your needs.