CDSCO License for Breathing circuit bag

Introduction to Breathing Circuit Bag and Regulatory Importance

Breathing circuit bags play a crucial role in anesthesiology by storing breathing gas during the respiratory cycle. Classified under Class A medical devices by CDSCO, these devices are considered low risk but still demand adherence to stringent regulatory requirements to ensure patient safety and market compliance in India. With over 25 years of experience and having helped more than 500 companies secure their CDSCO licenses, we provide clear, step-by-step guidance to manufacturers and importers aiming to launch breathing circuit bags in the Indian market.

CDSCO Regulatory Framework for Breathing Circuit Bags

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, categorizing devices into Classes A, B, C, and D based on risk. Breathing circuit bags fall under Class A, the lowest risk category, governed by the Medical Device Rules (MDR) 2017 and latest notifications such as Notification 29/Misc/03/2020-DC(177) dated 12.07.2021. Compliance with CDSCO’s framework ensures safety, efficacy, and quality for devices used in anesthesiology.

Risk Classification and License Requirements

As a Class A device, the breathing circuit bag requires a Manufacturing License under Form MD5, which is granted by the State Licensing Authority. The license process is designed to be straightforward but involves multiple steps including test licensing, product testing, documentation, and audits.

Risk Class: A (Low risk)
License Type: MD5 (Application Form MD3)
Authority: State Licensing Authority
Total Timeline: Approximately 3-4 months
Fees: ₹5000 per application + ₹500 per product

For detailed classification information, you can visit our Medical Device Classification guide.

Manufacturing License Process for Breathing Circuit Bags (MD5)

Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license on Form MD13. This allows product testing and lasts for 1.5 to 2 months.
Product Testing: Conduct testing of the breathing circuit bags in CDSCO-approved government or notified laboratories. Refer to the Testing Laboratories list to select an appropriate lab.
Documentation Preparation: Compile all required documents such as Device Master File, Plant Master File, risk management files, and QMS documentation.
License Application Submission: Submit the manufacturing license application on the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: A notified body conducts an audit at your manufacturing premises. Check the list of notified bodies for qualified agencies.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant: Upon successful audit and document verification, the MD5 license is granted.

For a detailed stepwise guide, consult our MD5 License Guide.

Manufacturing License Documents Required for Breathing Circuit Bags

To streamline your application, ensure the following documents are meticulously prepared:

Company Constitution (Incorporation Certificate, MOA, AOA)
Proof of Ownership or Lease Agreement of the manufacturing premises
Qualification and experience certificates of technical staff
Fire NOC and Pollution Control Board NOC
Device Master File (DMF): Detailed product specifications, design, manufacturing process (Guide to Device Master File)
Plant Master File (PMF): Information on manufacturing facility, quality control labs (Plant Master File Guide)
Essential Principles Checklist demonstrating compliance with safety standards
Risk Management File outlining hazard analysis and mitigation (Risk Management Guide)
Product Test Reports from CDSCO-approved labs
Product Labels and Instructions for Use (IFU)
Quality Management System Documents (ISO 13485 certification recommended)

Attention to detail in document preparation minimizes delays and query cycles.

Import License Process for Breathing Circuit Bags (MD15)

For importers wishing to bring breathing circuit bags into India, an Import License (MD15) is required, granted by the Central Licensing Authority. Though your device is Class A, the import license process is centralized and generally takes 5-6 months.

Key steps include:

Document preparation (including manufacturing license from country of origin, Free Sale Certificate, ISO 13485, CE Certificate, Device Master File, and Plant Master File)
Application submission through the CDSCO MD Online Portal
Queries resolution
License grant on Form MD15

Detailed guidance is available in our Import License Guide.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate or equivalent
Device Master File
Plant Master File
Wholesale license as applicable
Company Constitution documents

Government fees for Class A devices stand at approximately $1000 per site plus$ 50 per product.

Timeline and Processing Duration

Process Step	Duration
Test License (MD13)	1.5 – 2 months
Product Testing	2 – 3 weeks
Documentation Preparation	2 – 4 weeks
Application Submission	Immediate
Audit by Notified Body	3 – 4 weeks
Query Resolution	2 – 3 weeks
License Grant (MD5)	Total ~3-4 months

Planning your timeline with buffer periods for testing and audit scheduling is crucial to avoid surprises.

Government Fees and Costs

Application fee for MD5 license: ₹5000
Per product fee: ₹500 per product
Audit and testing costs vary depending on notified body and testing laboratory fees, typically ranging from ₹50,000 to ₹1,00,000

Budgeting for these fees upfront can prevent financial delays.

Common Challenges and Solutions

Delays in Testing: Choose a reliable CDSCO-approved lab from the start and schedule tests early.
Incomplete Documentation: Use checklists and expert consultation to ensure all documents meet CDSCO standards.
Audit Non-Compliance: Prepare your facility and QMS rigorously; conduct mock audits.
Query Management: Respond promptly with clear, documented evidence.

Our experience shows proactive preparation cuts processing times significantly.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time applicants. With our extensive experience assisting 500+ companies, we provide tailored support including:

Comprehensive document review and gap analysis
Mock audits and readiness assessments
Application submission and follow-up
Liaison with CDSCO and notified bodies

Partnering with seasoned consultants can improve your chances of timely approval and market entry.

Getting Started with Your CDSCO License Application for Breathing Circuit Bags

Assess your device classification and applicable license type (MD5 for manufacturing).
Register your company on the CDSCO MD Online Portal.
Initiate the test license (Form MD13) application to begin product testing.
Select a CDSCO-approved testing laboratory early to avoid delays.
Prepare all required documentation with attention to detail, leveraging our guides on Device and Plant Master Files.
Plan and schedule the manufacturing site audit with a notified body from the official notified bodies list.
Submit your manufacturing license application (Form MD3) through the portal and respond promptly to queries.

Taking these practical steps with expert guidance will streamline your CDSCO licensing journey for breathing circuit bags, enabling you to successfully enter the Indian anesthesiology device market.

For personalized assistance, reach out to our regulatory experts who specialize in CDSCO licensing and medical device compliance.

CDSCO License for Breathing circuit bag

Medical Device Information

Important Notice for Class A Devices

Intended Use