CDSCO License for Anaesthesia warmer
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 warm the anaesthetic solutions prior to it being administered to a patient for anaesthesia.
Comprehensive Guide to CDSCO Licensing for Anaesthesia Warmer (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we understand the nuances of medical device approvals in India. This guide specifically addresses the regulatory pathway for an Anaesthesia Warmer, a Class A medical device designed to warm anaesthetic solutions before administration, classified under anesthesiology.
Understanding the Anaesthesia Warmer and Its Regulatory Importance
An Anaesthesia Warmer plays a critical role in patient safety by ensuring that anaesthetic solutions are warmed appropriately, preventing hypothermia and improving efficacy. Given its direct interaction with patient care, the device is categorized as Class A under CDSCO's risk classification system, denoting low risk but still requiring compliance with regulatory standards.
Proper licensing through the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing this device in India. This ensures product safety, quality, and adherence to essential principles.
CDSCO Regulatory Framework for Anaesthesia Warmer
The CDSCO regulates medical devices under the Medical Device Rules, 2017, with specific provisions for Class A devices. Since your Anaesthesia Warmer falls under Class A (low risk), the manufacturing license must be obtained from the State Licensing Authority via the MD5 license route.
Manufacturers must also secure a Test License (MD13) initially to conduct necessary testing in government-approved laboratories.
Risk Classification and License Requirements for Anaesthesia Warmer
- Device Name: Anaesthesia Warmer
- Risk Class: A (Low Risk)
- Category: Anesthesiology
- Notification Number: 29/Misc/03/2020-DC(177)
- Notification Date: 12.07.2021
Due to its Class A classification, the following applies:
| License Type | Authority | Application Form | Typical Processing Time | Fees |
|---|---|---|---|---|
| MD5 Manufacturing License | State Licensing Authority | MD3 | 3-4 months (including test license & audit) | Rs 5,000 + Rs 500 per product |
Manufacturing License Process for Anaesthesia Warmer (MD5 License)
- Apply for Test License (Form MD13): Before full manufacturing, manufacturers need a test license. This allows sample testing in CDSCO-approved labs.
- Product Testing: Samples of Anaesthesia Warmers must be tested in government-approved laboratories for compliance with Indian standards. Refer to the list of testing laboratories for authorized facilities.
- Document Preparation: Comprehensive documentation must be compiled, including Device Master File, Plant Master File, risk management files, and quality management system documents.
- Submit Manufacturing License Application (Form MD3): File the MD5 license application via the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body conducts a compliance audit at the manufacturing site. Check the list of notified bodies for approved auditors.
- Query Resolution: Address queries raised by the licensing authority or notified body promptly.
- Grant of License: Upon successful audit and document review, the MD5 license is issued, authorizing the manufacture of Anaesthesia Warmers.
Manufacturing License Documents Required for Anaesthesia Warmer
To ensure a smooth application process, the following documents must be prepared meticulously:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of ownership or legal occupancy of manufacturing premises (rent/lease agreement or property deed)
- Details and qualifications of technical staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF): Detailed product specifications, design, and manufacturing process documentation. Our comprehensive Device Master File guide can help you prepare this.
- Plant Master File (PMF): Information about the manufacturing facility and equipment. Learn more from our Plant Master File guide.
- Essential Principles Checklist confirming conformity with Indian regulatory standards
- Risk Management File demonstrating hazard analysis and mitigation strategies
- Test Reports from approved labs
- Product Labels and Instructions For Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process for Anaesthesia Warmer (MD15 License)
For importers of Anaesthesia Warmers, the MD15 license from the Central Licensing Authority is mandatory. The process involves:
- Preparing all relevant documents including manufacturing license of the exporter, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate if applicable, Device Master File, Plant Master File, wholesale license, and company constitution.
- Applying on the CDSCO MD Online Portal.
- Resolving any queries raised by the CDSCO.
- License grant typically takes 5-6 months.
Import License Documents Required
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License issued by state authority
- Company Constitution documents
Timeline and Processing Duration
| License | Steps Involved | Duration |
|---|---|---|
| Test License (MD13) | Application, lab testing | 1.5-2 months |
| Manufacturing License (MD5) | Application, audit, query resolution | 3-4 months (post test license) |
| Import License (MD15) | Document review, query resolution | 5-6 months |
Manufacturers should anticipate approximately 4-6 months from start to finish for domestic manufacturing approval, including testing and audits.
Government Fees and Costs for Anaesthesia Warmer
- MD5 License Application fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
These fees apply specifically to Class A devices such as the Anaesthesia Warmer.
Common Challenges and Practical Solutions
Challenge 1: Delay in sample testing due to limited slots in government labs.
Solution: Plan ahead and book test slots early. Consider multiple labs from the CDSCO-approved list to avoid bottlenecks.
Challenge 2: Incomplete or inconsistent documentation leading to audit failures.
Solution: Follow standardized templates for Device Master File and Plant Master File. Utilize expert guidance to ensure all regulatory requirements are met.
Challenge 3: Query resolution delays due to unclear responses.
Solution: Provide detailed, evidence-backed answers with supporting documents. Maintain open communication with the licensing authority.
Expert Consultation and Support
Navigating CDSCO licensing for Class A devices like the Anaesthesia Warmer requires deep regulatory knowledge and practical experience. We offer:
- End-to-end application support
- Preparation of technical files and master files
- Coordination with notified bodies and labs
- Post-license compliance advisory
Our proven track record with 500+ successful licenses ensures your application is in expert hands.
Getting Started with Your CDSCO License Application
- Assess your product’s classification: Confirm your Anaesthesia Warmer is Class A using CDSCO guidelines.
- Prepare your Test License Application (MD13): Gather device samples and compile initial documents.
- Choose testing laboratories: Refer to the CDSCO Testing Laboratories list and schedule tests.
- Compile your Device and Plant Master Files: Use our Device Master File and Plant Master File guides.
- Register and submit applications via the CDSCO MD Online Portal: This is your official gateway for all medical device licensing.
- Prepare for audit: Select a notified body from the approved list and schedule audits.
Embarking on your CDSCO licensing journey with thorough preparation and expert guidance will significantly reduce processing time and increase approval success rates. Contact us to leverage our extensive experience and ensure your Anaesthesia Warmer reaches the Indian market compliantly and efficiently.
