CDSCO License for Breathing circuit gas- sampling/monitoring set

Comprehensive Guide to CDSCO Licensing for Breathing Circuit Gas-Sampling/Monitoring Set (Class B)

As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies in navigating the Indian medical device regulatory landscape, we understand the complexities manufacturers and importers face in obtaining the necessary CDSCO licenses. This guide focuses specifically on the Breathing Circuit Gas-Sampling/Monitoring Set, a Class B medical device under the anesthesiology category (Notification: 29/Misc/03/2020-DC(177), dated 12.07.2021).

Introduction: Device Overview and Regulatory Importance

The Breathing Circuit Gas-Sampling/Monitoring Set is a critical component used within anesthesia delivery systems. It enables the interface between the patient’s breathing circuit and respiratory monitoring devices, facilitating the sampling and analysis of expired gases including pressure and flow metrics essential for patient safety. Given its role in monitoring and diagnostic processes, regulatory compliance is paramount to ensure device safety, efficacy, and quality.

CDSCO Regulatory Framework for Breathing Circuit Gas-Sampling/Monitoring Set

In India, the Central Drugs Standard Control Organization (CDSCO) governs medical device regulation. The device in question falls under Class B, indicating a moderate risk level. According to the Medical Device Rules (MDR) 2017 and subsequent notifications, Class B devices require a State Licensing Authority-issued MD5 manufacturing license for local manufacturing and an MD15 import license if imported.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk)
• License Type for Manufacturing: MD5 License (Application Form MD3)
• License Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months

Manufacturers must first obtain a test license (Form MD13) before applying for the MD5 license. This is followed by product testing and audits.

Manufacturing License Process (MD5)

The MD5 license process involves several critical steps:

1. Test License (Form MD13): Initially, apply for a test license which typically takes 1.5 to 2 months.
2. Product Testing: Conduct product testing at government-approved laboratories. Refer to the CDSCO Testing Laboratories list to select an accredited lab.
3. Document Preparation: Prepare the comprehensive dossier including technical files and quality systems.
4. Application Submission: File the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit of the manufacturing facility is conducted by a notified body. Check the list of notified bodies for approved auditors.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon successful review and audit, the MD5 manufacturing license is issued (Form MD5).

For detailed insights, our MD5 License Guide provides step-by-step assistance.

Manufacturing License Documents Required

The following documents are mandatory for MD5 license application for a Class B device:

• Company Constitution Documents (e.g., Incorporation Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Details and experience
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed technical specifications and manufacturing process (DMF Guide)
• Plant Master File (PMF): Manufacturing environment and quality systems (PMF Guide)
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File: Documentation of risk analysis and mitigation as per ISO 14971 (Risk Management Guide)
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation (e.g., ISO 13485:2016 certificates)

Import License Process (MD15)

If you are an importer of the Breathing Circuit Gas-Sampling/Monitoring Set, you must obtain an MD15 import license:

1. Document Preparation: Collate all required documents including manufacturing license, ISO certification, Free Sale Certificate, and others detailed below.
2. Application Submission: Submit the application on the CDSCO MD Online Portal.
3. Query Resolution: Respond to any department queries.
4. License Grant: Receive the MD15 import license (Form MD15).

Notably, unlike the manufacturing license, no test license or product testing is mandated for import licensing.

Import License Documents Required

Key documents required for MD15 application include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale drug license (if applicable)
• Company Constitution Documents

For more details, refer to our Import License Guide.

Timeline and Processing Duration

Manufacturers should plan accordingly to accommodate these timelines and avoid market entry delays.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• Test License (MD13): Usually included within the MD5 licensing process fees

Costs related to audits, testing, and document preparation vary based on notified bodies and laboratories selected.

Common Challenges and Solutions

• Challenge: Delays in audit scheduling or test report generation.

  • Solution: Engage notified bodies early and pre-book audits; choose reputed testing labs with faster turnaround.

• Challenge: Incomplete or inconsistent documentation leading to query cycles.

  • Solution: Utilize detailed checklists and expert consultation to ensure dossier completeness.

• Challenge: Understanding regulatory updates and notifications.

  • Solution: Stay updated with CDSCO circulars and subscribe to regulatory newsletters.

Expert Consultation and Support

Navigating the CDSCO regulatory system for Class B devices like the Breathing Circuit Gas-Sampling/Monitoring Set can be intricate. With our extensive experience, we provide end-to-end support including:

• Gap analysis and readiness assessment
• Complete documentation support
• Audit preparation and liaison with notified bodies
• Query handling and follow-up with CDSCO

Our personalized approach has helped over 500 companies achieve timely license approvals.

Getting Started with Your CDSCO License Application

1. Assess your device classification to confirm Class B status. Use resources like the Medical Device Classification guide.
2. Gather preliminary documents including your company constitution, technical staff details, and proof of premises.
3. Apply for the test license (Form MD13) via the CDSCO MD Online Portal.
4. Coordinate product testing with an approved laboratory early to avoid delays.
5. Prepare the Device Master File and Plant Master File meticulously; refer to our comprehensive guides.
6. Schedule audits with notified bodies promptly after test reports are ready.
7. Submit the MD5 application (Form MD3) once audit readiness is confirmed.

Embarking on this process with expert guidance ensures a smooth regulatory journey. Contact us to leverage our decades of expertise and secure your CDSCO license efficiently.