CDSCO License for Anaesthesia workstation gas scavenger
Medical Device Information
Intended Use
A device intended to connect between the expiratory valve/port of a breathing circuit and the extraction system enabling the waste anaesthetic, exhaled, or other trace gases to be removed under controlled conditions from the work environment and channelled to the outside of the building.
Comprehensive Guide to CDSCO Licensing for Anaesthesia Workstation Gas Scavenger
As seasoned regulatory consultants with over 25 years of experience and having successfully supported 500+ companies in medical device licensing, we understand the complexity of navigating the CDSCO regulatory landscape for devices like the Anaesthesia Workstation Gas Scavenger. This device, classified as Class B under Indian regulations, plays a crucial role in anesthesiology by safely removing waste anesthetic gases from operating rooms, ensuring compliance with safety standards and environmental controls.
CDSCO Regulatory Framework for Anaesthesia Workstation Gas Scavenger
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The Anaesthesia Workstation Gas Scavenger falls under the anesthesiology category and is notified under the CDSCO notification number 29/Misc/03/2020-DC(177), dated 12.07.2021. This classification as a Class B device means it is considered low to moderate risk, requiring a manufacturing license (MD5) from the respective State Licensing Authority.
Risk Classification and License Requirements
Class B devices like the Anaesthesia Workstation Gas Scavenger require an MD5 manufacturing license. The MD5 license process is streamlined through the CDSCO MD Online Portal and involves obtaining a test license (MD13), product testing at government-approved laboratories, a notified body audit, and comprehensive documentation submission.
Understanding this classification helps manufacturers and importers prepare the correct application forms and documentation, avoiding costly delays.
Manufacturing License Process (MD5) for Class B Devices
The manufacturing license for Class B devices is granted by the State Licensing Authority and generally takes around 3-4 months to complete. Here’s a step-by-step outline:
- Apply for Test License (Form MD13): Before manufacturing, you must secure a test license, which takes approximately 1.5-2 months. This allows you to manufacture the device for testing purposes.
- Product Testing: Submit your Anaesthesia Workstation Gas Scavenger samples to CDSCO-approved testing laboratories for product evaluation. Refer to the Testing Laboratories list to choose an appropriate facility.
- Document Preparation: After receiving test reports, prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and others.
- Application Submission (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal along with required documents.
- Notified Body Audit: Coordinate with a notified body for an on-site audit. Check the list of notified bodies for available options.
- Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
- License Grant (Form MD5): Upon successful audit and documentation review, the MD5 manufacturing license will be granted.
Manufacturing License Documents Required
For your Anaesthesia Workstation Gas Scavenger, ensure you have the following documents ready:
- Company constitution documents (Certificate of Incorporation, Memorandum & Articles of Association)
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire and pollution clearance certificates (NOCs)
- Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
- Plant Master File (PMF) outlining facility and quality management systems (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File documenting identified risks and mitigation strategies (Risk Management Guide)
- Test reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) compliant with Indian regulations
- Quality Management System (QMS) documentation such as ISO 13485:2016 certificates
Import License Process (MD15) for Anaesthesia Workstation Gas Scavenger
If you intend to import the Anaesthesia Workstation Gas Scavenger into India, you must obtain an MD15 import license from the Central Licensing Authority. The process generally takes 5-6 months and includes:
- Document preparation including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, and Wholesale License
- Application submission via CDSCO MD Online Portal
- Queries resolution
- License grant
For detailed guidance, consult our Import License Guide.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate or Certificate to Foreign Government
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company constitution documents
Timeline and Processing Duration
| License Type | Processing Authority | Estimated Time |
|---|---|---|
| Test License (MD13) | State Licensing Authority | 1.5 – 2 months |
| Manufacturing License (MD5) | State Licensing Authority | 3 – 4 months (including test license, testing, audit) |
| Import License (MD15) | Central Licensing Authority | 5 – 6 months |
Government Fees and Costs
For the Anaesthesia Workstation Gas Scavenger as a Class B device, the fee structure is as follows:
- Test License (MD13): No additional fees beyond standard application fees.
- Manufacturing License (MD5): Rs. 5,000 per application + Rs. 500 per product
These fees are payable via the CDSCO MD Online Portal.
Common Challenges and Solutions
Challenge: Delays due to incomplete or incorrect documentation.
Solution: Early preparation of comprehensive documentation is crucial. Use checklists and expert consultations to ensure completeness.
Challenge: Difficulty securing timely audits by notified bodies.
Solution: Engage with notified bodies early and maintain flexibility in scheduling. Refer to the updated Notified Bodies list for options.
Challenge: Test failures or inadequate test reports.
Solution: Choose CDSCO-approved testing labs carefully and conduct internal pre-testing to mitigate risks.
Expert Consultation and Support
Navigating the CDSCO licensing process for your Anaesthesia Workstation Gas Scavenger can be complex. Our team, with extensive regulatory expertise, offers tailored support including:
- Gap analysis and readiness assessments
- Documentation preparation and review
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Training on regulatory compliance
Our proven track record with over 500 successful client projects ensures your journey is efficient and compliant.
Getting Started with Your CDSCO License Application
- Determine your licensing pathway: Since your device is Class B, focus on the MD5 manufacturing license.
- Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the submission process.
- Prepare and submit your test license (MD13) application: Begin manufacturing for testing after approval.
- Coordinate product testing: Select a CDSCO-recognized lab from the Testing Laboratories list.
- Compile required documents: Leverage our guides on Device Master File and Plant Master File preparation.
- Apply for the manufacturing license (MD5) using Form MD3: Submit via the CDSCO portal.
- Plan for notified body audit: Engage early with a notified body.
- Respond promptly to queries: Expedite processing by addressing any regulatory concerns immediately.
By following these practical steps and leveraging expert support, your Anaesthesia Workstation Gas Scavenger can achieve CDSCO licensing efficiently, enabling you to access the Indian market confidently and compliantly.
