CDSCO License for Circulating-fluid whole-body heating/cooling system pad, single- use
Medical Device Information
Intended Use
A non-sterile 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, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Circulating-Fluid Whole-Body Heating/Cooling System Pads (Single-Use)
As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 medical device companies, we understand the critical nuances of obtaining CDSCO licenses in India. This guide focuses on the Circulating-fluid whole-body heating/cooling system pad, single-use, a Class B pediatric device designed for clinical use in ORs, ICUs, and recovery units. We provide you with detailed insights on the regulatory framework, timelines, costs, and documentation to help you smoothly navigate the licensing process.
Understanding Your Device and Its Regulatory Importance
The circulating-fluid whole-body heating/cooling system pad is a non-sterile, single-use medical device that functions as an underlay or overlay circulating temperature-regulated fluids to modulate patient core body temperature. Given its critical role in pediatric and neonatology care, regulatory compliance ensures patient safety and market access. The CDSCO notification (File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021) explicitly classifies this device as Class B, indicating a moderate risk level.
CDSCO Regulatory Framework for Class B Medical Devices
In India, medical devices like your heating/cooling pad fall under the Medical Device Rules (MDR) 2017, governed by the Central Drugs Standard Control Organization (CDSCO). Class B devices require a manufacturing license (MD5) issued by the State Licensing Authority, following a prescribed audit and product testing process.
Risk Classification and License Requirements
Your device's Class B classification means it is a moderate-risk device necessitating:
- A Test License (Form MD13) to conduct product testing in CDSCO-approved labs
- Product testing and certification
- Submission of a detailed dossier
- Audit by a notified body
- Application for a manufacturing license on Form MD3 (MD5 License)
For detailed classification criteria, refer to Medical Device Classification.
Manufacturing License Process (MD5) for Your Device
The entire MD5 licensing process generally spans 3 to 4 months and involves these sequential steps:
Apply for Test License (Form MD13): Initiate testing by applying for this license via the CDSCO MD Online Portal. Processing time is typically 1.5 to 2 months.
Product Testing: Conduct mandatory product testing at government-approved testing laboratories, such as those listed on the CDSCO Testing Laboratories page.
Documentation Preparation: Compile a comprehensive dossier including Device Master File, Plant Master File, risk management, and essential principles checklist.
Submit MD5 License Application (Form MD3): File your manufacturing license application through the CDSCO portal.
Audit by Notified Body: Your facility will undergo an audit by a notified body from the official Notified Bodies List.
Query Resolution: Address any queries raised by the department or notified body promptly.
Grant of License: Upon satisfactory compliance, the State Licensing Authority will issue the MD5 manufacturing license.
Manufacturing License Documents Required
For a Class B device like the circulating-fluid heating/cooling pad, you must prepare the following key documents:
- Company Constitution (Incorporation Certificate, PAN, GST)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details of Technical Staff Qualifications and Experience
- Fire NOC and Pollution Control Board NOC
- Device Master File: Detailed design and manufacturing process documents (Device Master File Guide)
- Plant Master File: Facility layout, equipment details, and quality systems (Plant Master File Guide)
- Essential Principles Checklist: Compliance with safety and performance standards
- Risk Management File: Documentation of risk analysis and mitigation (Risk Management)
- Test Reports from Government-Approved Labs
- Labels and Instructions for Use (IFU): Clear and compliant labeling
- Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification
Import License Process (MD15) for Importers
Since your device is a Class B medical device, imports require an MD15 license granted by the Central Licensing Authority. The process is as follows:
- Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
- Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
- Query Resolution: Address any department queries.
- License Grant: Typically completed within 5-6 months.
For detailed guidance, visit our Import License Guide.
Timeline and Processing Duration
| Process Step | Typical Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Documentation Preparation | 3 - 4 weeks |
| MD5 License Application (MD3) | 1 - 2 months (including audit and query resolution) |
| Total Estimated Time | 3 - 4 months |
Government Fees and Costs
The CDSCO fees for MD5 licensing are structured as follows:
- Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
Additional costs include:
- Testing laboratory fees (variable, depending on test complexity)
- Notified body audit fees (typically INR 50,000 - 1,00,000 depending on body)
- QMS certification and consulting fees (if applicable)
Budgeting realistically for the entire process is critical to avoid delays.
Common Challenges and Practical Solutions
Challenge 1: Delays in product testing due to backlog at government labs.
- Solution: Plan and submit your test license application early. Consider labs with shorter lead times from the approved list.
Challenge 2: Incomplete or inconsistent documentation.
- Solution: Use templates and consult experts for the Device and Plant Master Files, risk management, and QMS documentation. Our MD5 License Guide offers detailed checklists.
Challenge 3: Audit non-compliance due to facility or procedural gaps.
- Solution: Conduct internal pre-audit assessments and engage notified bodies early for consultancy.
Challenge 4: Query resolution delays.
- Solution: Respond comprehensively and within stipulated timelines to CDSCO queries to avoid prolonged processing.
Expert Consultation and Support
Navigating the CDSCO licensing landscape for Class B devices like your circulating-fluid heating/cooling pad can be complex. With over two decades of expertise and success stories from 500+ clients, we provide:
- End-to-end regulatory strategy and application preparation
- Pre-audit readiness and gap analysis
- Device Master File and Plant Master File drafting
- Liaison with CDSCO, notified bodies, and testing labs
- Training on compliance and quality management systems
Our consultative approach reduces your time-to-market and mitigates compliance risks.
Getting Started with Your CDSCO License Application
To initiate your licensing journey:
Evaluate Your Device Classification and Regulatory Obligations: Confirm your device class and required licenses via the CDSCO MD Online Portal.
Prepare Technical Documentation: Begin compiling your Device Master File and Plant Master File using our detailed guides.
Apply for a Test License (Form MD13): Submit your application early to avoid testing delays.
Schedule Product Testing: Coordinate with government-approved labs promptly.
Plan for Notified Body Audit: Select an appropriate notified body from the official list and schedule your audit.
Submit Manufacturing License Application (Form MD3): After successful testing and audit, apply for your MD5 license.
Engage Expert Support: Consider partnering with experienced regulatory consultants to streamline the process.
Embarking on your CDSCO licensing process with a clear roadmap and expert backing ensures compliance, builds trust with stakeholders, and accelerates your product’s access to the Indian healthcare market. Reach out to our team today to discuss tailored solutions for your circulating-fluid whole-body heating/cooling system pad.
For more insights and detailed regulatory assistance, explore our resources or contact us directly. Your path to successful CDSCO licensing starts here.
