CDSCO License for Medical gas flowmeter, Thorpe tube
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A device intended to measure and regulate the flow of a medical gas during various procedures.
Comprehensive Guide to CDSCO Licensing for Medical Gas Flowmeter (Thorpe Tube) – Class A Device
Medical gas flowmeters, specifically the Thorpe tube type, are critical devices used in anesthesiology to measure and regulate the flow of medical gases during various procedures. Given their direct impact on patient safety and clinical outcomes, regulatory compliance in India is mandatory before manufacturing or importing these devices. With over 25 years of experience supporting 500+ companies, we provide an expert roadmap to navigate the CDSCO licensing process for this Class A medical device.
CDSCO Regulatory Framework for Medical Gas Flowmeter (Thorpe Tube)
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. Medical gas flowmeters fall under the anesthesiology category and are classified as Class A devices – the lowest risk category. As per CDSCO notification [29/Misc/03/2020-DC(177)] dated 12.07.2021, these devices require a manufacturing license (MD5) from the State Licensing Authority before commercial operations.
Understanding the regulatory framework is key to ensuring compliance and market access. The MD5 license is designed to streamline processes for low-risk devices while maintaining quality and safety standards.
Risk Classification and License Requirements for Medical Gas Flowmeter
The Medical Gas Flowmeter (Thorpe tube) is categorized as a Class A device based on its intended use and risk profile. Class A devices are considered low risk and must obtain an MD5 manufacturing license under Form MD3, issued by the State Licensing Authority.
Key regulatory requirements include:
- Obtaining a Test License (MD13) before starting manufacturing
- Product testing at CDSCO-approved laboratories
- Document submission including Device Master File and Plant Master File
- Audit by a notified body
For detailed classification guidance, you can refer to the Medical Device Classification resource.
Manufacturing License Process – MD5 License for Class A Devices
The MD5 license process for your medical gas flowmeter involves these sequential steps:
Apply for Test License (Form MD13): This initial license permits product testing and validation. Processing takes approximately 1.5 to 2 months.
Product Testing: Get the device tested at CDSCO-approved laboratories to verify compliance with essential principles. A list of Testing Laboratories can help you select authorized centers.
Documentation Preparation: Prepare and collate all required documents including Device Master File, Plant Master File, risk management files, QMS documents, etc.
Submit Manufacturing License Application (Form MD3) via the CDSCO MD Online Portal: The application is submitted to the State Licensing Authority.
Audit by Notified Body: A notified body conducts an on-site audit of your manufacturing site and quality systems. Refer to the list of notified bodies for audit arrangements.
Query Resolution: Address any queries raised by the regulatory authority or notified body promptly.
Grant of MD5 License: After successful audit and document approval, the license is granted on Form MD5.
This end-to-end process typically takes 3 to 4 months.
Manufacturing License Documents Required for Medical Gas Flowmeter
Preparing a complete and accurate submission package is crucial. The following documents are mandatory for an MD5 license application:
- Company Constitution and Memorandum of Association
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed description, design, specifications, and manufacturing process of the medical gas flowmeter. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Details about facility, infrastructure, equipment, and quality systems. Learn more from our Plant Master File Guide.
- Essential Principles Compliance Checklist
- Risk Management File specific to the device’s hazards and mitigation strategies. For deeper insights, visit our Risk Management resource.
- Test Reports from CDSCO-approved labs
- Product Labels, Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485 certification or equivalent)
Import License Process – MD15 License for Medical Gas Flowmeter
If you plan to import the medical gas flowmeter into India, an import license (MD15) from the Central Licensing Authority is required. The process involves:
- Document preparation including valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files, and Wholesale License.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any department queries.
The MD15 license process generally takes 5 to 6 months. Government fees vary based on risk class and number of products imported.
For detailed guidance, refer to our Import License Guide.
Import License Documents Required
Key documents for MD15 application include:
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution
Timeline and Processing Duration
| License Type | Duration | Key Steps |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Application, testing approval |
| Manufacturing License (MD5) | 3 – 4 months | Document submission, audit, query resolution |
| Import License (MD15) | 5 – 6 months | Document review, query resolution |
Planning your project timelines around these durations ensures smooth regulatory compliance without costly delays.
Government Fees and Costs
For the Medical Gas Flowmeter (Class A), the fees for MD5 license are as follows:
- Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500 per product
Additional costs may include audits by notified bodies, laboratory testing fees, and professional consulting charges. Budgeting for these expenses upfront is essential.
Common Challenges and Solutions
Challenge: Delays in obtaining test reports from approved laboratories.
Solution: Engage early with CDSCO-approved labs and pre-book testing schedules to avoid bottlenecks.
Challenge: Incomplete or inconsistent documentation leading to queries.
Solution: Use comprehensive checklists and expert reviews to ensure all documents, including Device and Plant Master Files, are accurate and compliant.
Challenge: Audit non-conformities during notified body inspection.
Solution: Prepare your quality systems thoroughly, conduct internal audits based on ISO 13485, and address potential gaps before the official audit.
Our extensive experience guides clients to anticipate and overcome these hurdles efficiently.
Expert Consultation and Support
Navigating regulatory requirements can be complex. Our seasoned consultants offer tailored support for:
- Device classification and regulatory strategy
- Documentation preparation including DMF and PMF
- Audit readiness and quality system implementation
- Liaison with CDSCO and notified bodies
Partnering with experts accelerates approval timelines and reduces compliance risks.
Getting Started with Your CDSCO License Application
To initiate your journey towards obtaining the MD5 license for your Medical Gas Flowmeter (Thorpe tube), follow these practical steps:
Register on the CDSCO MD Online Portal: Create a user account to access application forms and track submissions.
Prepare and Submit Test License (MD13) Application: Start product testing at an approved lab.
Develop and Compile Required Documents: Leverage our guides on Device Master File and Plant Master File for thorough preparation.
Schedule and Coordinate Notified Body Audit: Choose a notified body from the official list and prepare your manufacturing site.
Submit Manufacturing License Application (MD3) Online: Ensure all documents and test reports are uploaded correctly.
Respond Promptly to Queries: Maintain active communication with CDSCO and notified bodies to resolve issues swiftly.
Receive Your MD5 License: Begin manufacturing and marketing your medical gas flowmeter in India legally.
For personalized assistance, connect with our regulatory experts who have successfully guided over 500 companies through the CDSCO licensing process. Our proven methodologies and hands-on support can make your compliance journey smoother and faster.
Embarking on CDSCO registration for your Medical Gas Flowmeter requires meticulous planning and expert knowledge. By following this comprehensive guide and leveraging professional support, you can confidently enter the Indian market with full regulatory compliance and operational readiness.
