CDSCO License for Circulating-air whole- body heating/cooling system pad, reusable
Medical Device Information
Intended Use
An underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device.
Comprehensive CDSCO Licensing Guide for Circulating-Air Whole-Body Heating/Cooling System Pads (Reusable) – Class B Medical Device
Introduction: Understanding Your Device and Regulatory Importance
The circulating-air whole-body heating/cooling system pad (reusable) is a sophisticated medical device designed primarily for pediatric and neonatology use. It functions as an underlay or overlay pad that circulates heated or cooled air to regulate core body temperature in patients, often used in critical care and surgical settings. Given its direct impact on patient temperature control, ensuring compliance with Indian regulatory standards is essential for market access.
At our consultancy, with over 25 years of expertise and having assisted 500+ manufacturers and importers, we understand the nuances and critical steps required to obtain a valid CDSCO license for this Class B device. This guide will walk you through the regulatory framework, risk classification, licensing process, timelines, costs, and practical tips to ensure a smooth application.
CDSCO Regulatory Framework for Circulating-Air Whole-Body Heating/Cooling System Pads
In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. The device in question is notified under File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021, categorizing it within the pediatric and neonatology segment.
As a Class B medical device, this heating/cooling pad falls under the category of low-moderate risk devices, requiring manufacturing license approval by the State Licensing Authority through an MD5 license.
For more information on device classifications, you can consult the Medical Device Classification guide.
Risk Classification and License Requirements for Class B Devices
The circulating-air heating/cooling system pad is classified as Class B due to its reusable nature and its critical physiological function.
License Type: MD5 (Manufacturing License for Class A and B devices)
Governing Authority: State Licensing Authority
Application Form: MD3
Additional Requirements: Test license (MD13) before MD5 application, product testing in CDSCO-approved laboratories, and audit by a notified body.
Manufacturing License Process (MD5) for Class B Devices
Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must secure a test license for the device, allowing initial manufacturing for testing purposes. This process typically takes 1.5 to 2 months.
Product Testing: Conduct product testing at CDSCO-approved testing laboratories. The device’s safety, performance, and compliance with essential principles are tested rigorously. Refer to the list of approved testing laboratories.
Document Preparation: Compile all required documents, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and QMS documentation.
MD5 License Application (Form MD3): Submit your application through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts an on-site audit of your manufacturing facility. You can check the list of notified bodies authorized for this audit.
Query Resolution: Address any queries raised by the State Licensing Authority or notified body promptly.
Grant of MD5 License: Upon successful audit and documentation verification, the MD5 license is granted on Form MD5.
Total processing time for the entire MD5 license process typically spans 3 to 4 months.
For detailed guidance, consult our MD5 License Guide.
Manufacturing License Documents Required for Circulating-Air Heating/Cooling Pads
To ensure a smooth application, prepare the following essential documents:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Technical Staff (qualifications and experience)
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, manufacturing, and specifications. Our comprehensive Device Master File guide can assist you.
- Plant Master File (PMF) describing the manufacturing environment and processes. Check our Plant Master File guide for best practices.
- Essential Principles Checklist confirming compliance with Indian MDR
- Risk Management File documenting identified risks and mitigation strategies. Learn more about Risk Management.
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, often aligned with ISO 13485:2016
Import License Process (MD15) for Circulating-Air Heating/Cooling Pads
If you intend to import this device into India, an MD15 import license is mandatory.
Key Points:
- Granted by the Central Licensing Authority
- Application Form: MD14
- No test license required for import
- Requires submission of manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, DMF, PMF, and wholesale license
- Processing time: Approximately 5 to 6 months
Submit your application through the CDSCO MD Online Portal.
For a detailed process, refer to our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File (DMF)
- Plant Master File (PMF)
- Wholesale License for medical devices
- Company Constitution documents
Timeline and Processing Duration
| License Type | Processing Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5–2 months | Testing permission for initial production |
| Manufacturing License (MD5) | 3–4 months (including test license time) | Product testing, audit, and license grant |
| Import License (MD15) | 5–6 months | Document verification and license grant |
Plan your timelines accordingly to avoid delays, especially considering audit scheduling and laboratory testing lead times.
Government Fees and Costs
For the Class B circulating-air heating/cooling pad, expect the following fees:
MD5 License:
- Application fee: ₹5,000
- Per product fee: ₹500
Test License (MD13): Included in MD5 process, no separate fee mentioned
Import License (MD15):
- Site fee: $2,000
- Per product fee: $1,000
Note that currency conversions and periodic fee revisions may apply. Budget for additional costs such as notified body audit fees, testing laboratory charges, and consultancy support.
Common Challenges and Solutions
1. Delays in Test License Approval:
- Solution: Submit a complete and error-free application; engage with the CDSCO helpdesk early.
2. Difficulty Scheduling Notified Body Audits:
- Solution: Choose notified bodies from the official list of notified bodies early and book audits well in advance.
3. Incomplete Documentation:
- Solution: Use checklists and templates for DMF, PMF, and risk files. Refer to our guides for best practices.
4. Product Testing Failures:
- Solution: Conduct pre-testing at accredited labs before official CDSCO testing.
5. Query Resolution Delays:
- Solution: Prepare comprehensive responses and consult with regulatory experts for clarity.
Expert Consultation and Support
Our extensive experience with over 500 successful CDSCO license approvals enables us to provide tailored support from initial classification through license grant. We assist with:
- Gap analysis of your current documentation
- Preparation of DMF, PMF, and risk management files
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Training your team on compliance requirements
Engaging expert consultants early can reduce timelines and mitigate risks of application rejection.
Getting Started with Your CDSCO License Application for Circulating-Air Whole-Body Heating/Cooling Pads
Step 1: Confirm your device’s classification as Class B and review the MDR 2017 notifications.
Step 2: Assemble your core team for regulatory, quality, and technical documentation preparation.
Step 3: Prepare and submit the Test License application (Form MD13) via the CDSCO MD Online Portal.
Step 4: Coordinate with a CDSCO-approved testing laboratory for product testing.
Step 5: Develop and finalize all required documentation – DMF, PMF, Risk Management File, etc.
Step 6: Apply for the MD5 Manufacturing License (Form MD3) after successful testing.
Step 7: Schedule and prepare for the notified body audit.
Step 8: Respond promptly to any queries and await license grant.
By following these structured steps and leveraging expert guidance, manufacturers can confidently navigate the CDSCO licensing process to bring their reusable circulating-air whole-body heating/cooling system pads to the Indian market.
For personalized assistance and turnkey regulatory solutions, feel free to reach out to our consultancy team with over two decades of proven expertise.
