CDSCO License for Circulating-fluid whole-body heating/cooling system pad, reusable
Medical Device Information
Intended Use
An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Circulating-Fluid Whole-Body Heating/Cooling System Pads (Reusable) – Class B Medical Device
As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully guided more than 500 manufacturers and importers through the complex CDSCO licensing process in India. This guide focuses on the regulatory requirements for a Circulating-fluid whole-body heating/cooling system pad, reusable, classified as a Class B device under the Pediatrics and Neonatology category.
Introduction to the Device and Regulatory Importance
The circulating-fluid whole-body heating/cooling system pad is a critical clinical device used in operating rooms, ICUs, and recovery units to regulate patient body temperature through temperature-controlled fluid circulation. Given its direct patient contact and role in critical care, the device falls under Class B risk classification, requiring stringent regulatory oversight. Compliance with CDSCO ensures patient safety, market access, and alignment with Indian medical device regulations.
CDSCO Regulatory Framework for Circulating-Fluid Heating/Cooling Pads
India’s Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. For Class B devices, the manufacturing license is issued by the State Licensing Authority under the MD5 license framework (Application Form MD3). This process includes obtaining a test license, product testing, audit by a notified body, and submission of detailed technical documentation.
Risk Classification and License Requirements
Our device is classified as Class B, which implies:
- Moderate risk requiring both technical and quality management controls.
- License application to the State Licensing Authority.
- Obtaining an MD5 Manufacturing License (Form MD3) is mandatory before commencing manufacturing.
For detailed classification criteria, refer to the Medical Device Classification guide.
Manufacturing License Process (MD5) for Class B Devices
The MD5 license process for Class B reusable medical devices involves several critical steps:
- Test License Application (Form MD13): Before applying for MD5, manufacturers must apply for a test license, which allows product testing in government-approved labs.
- Product Testing: Conduct testing of the heating/cooling pad in CDSCO-recognized laboratories to validate compliance with Indian standards. Use the Testing Laboratories list for approved labs.
- Document Preparation: Compile the required documents, including Device Master File, Plant Master File, and Risk Management File.
- Apply for MD5 License (Form MD3): Submit the complete application through the CDSCO MD Online Portal.
- Audit by Notified Body: The State Licensing Authority mandates an audit by a notified body to verify compliance. Check the list of notified bodies for audit assignments.
- Query Resolution: Address any queries raised by the CDSCO or notified body promptly.
- License Grant: Upon successful review and inspection, the MD5 license is granted, allowing commercial manufacturing.
For a detailed walkthrough, our MD5 License Guide is an excellent resource.
Manufacturing License Documents Required
To streamline your MD5 license application, ensure you prepare the following documents meticulously:
- Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association.
- Proof of Premises Ownership or Lease Agreement.
- Technical Staff Details: CVs, qualifications, and experience certificates of technical personnel.
- Fire NOC and Pollution Control Board NOC: Compliance certificates ensuring safety and environmental standards.
- Device Master File (DMF): Detailed specifications, design, manufacturing process, and biocompatibility data. Refer to our Device Master File guide for preparation tips.
- Plant Master File (PMF): Information on manufacturing premises, equipment, and quality control procedures. See our Plant Master File guide.
- Essential Principles Checklist: Compliance matrix with applicable standards and regulations.
- Risk Management File: Documentation of hazard analysis and risk mitigation compliant with ISO 14971. Learn more from our Risk Management guide.
- Test Reports: From CDSCO-approved labs validating device safety and performance.
- Labels and Instructions for Use (IFU): As per CDSCO labeling requirements.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal SOPs.
Import License Process (MD15) for Circulating-Fluid Heating/Cooling Pads
If you are an importer of this device into India, an MD15 Import License issued by the Central Licensing Authority is mandatory. The process includes:
- Preparing comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE Certificate, and master files.
- Application submission via the CDSCO MD Online Portal.
- Addressing any departmental queries.
- Awaiting license grant within 5-6 months.
Our Import License Guide offers practical insights.
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 (if applicable)
- Device Master File
- Plant Master File
- Wholesale License of the importer
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | Varies (2-4 weeks) |
| Application Processing (MD5) | 1.5 to 2 months |
| Audit and Inspection | 3 to 4 weeks |
| Query Resolution | 2 to 3 weeks |
| Total Time (MD5 License) | 3 to 4 months approx |
Note: Timelines may vary based on completeness of documentation and responsiveness.
Government Fees and Costs
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product variant
Additional costs include testing fees at government-approved laboratories and notified body audit charges, which vary by agency.
Common Challenges and Solutions
- Incomplete Documentation: We advise thorough preparation using checklists and expert review to avoid rejection.
- Delays in Product Testing: Engage with recognized labs early and schedule tests in advance.
- Audit Non-Compliance: Conduct pre-audit internal assessments and staff training.
- Query Management: Maintain clear and prompt communication with CDSCO and notified bodies.
Expert Consultation and Support
Navigating CDSCO licensing for reusable circulating-fluid whole-body heating/cooling system pads demands precise technical and regulatory knowledge. Our expert consultancy, with proven success in over 500 projects, offers:
- End-to-end application preparation and submission
- Documentation review and gap analysis
- Coordination with notified bodies and testing labs
- Timely response to regulatory queries
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm Class B classification and applicable rules.
- Engage Early with Testing Labs: Book slots and understand their specific requirements.
- Prepare Technical Files: Use our guides to develop device and plant master files and risk management documentation.
- Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
- Schedule Notified Body Audit: Coordinate audit timing during document preparation.
- Submit MD5 License Application (Form MD3): Once testing and audit are complete.
- Monitor Application Progress: Respond promptly to any queries.
We recommend leveraging professional regulatory consultants to streamline this process and avoid costly delays. Reach out to us for personalized support tailored to your circulating-fluid heating/cooling pad device.
By following these detailed steps and utilizing available resources, manufacturers and importers can confidently secure CDSCO licenses and successfully enter the Indian medical device market with their reusable heating/cooling system pads.
