CDSCO License for Neonatal hypothermia cot heat- conduction mattress
Medical Device Information
Intended Use
A non-sterile, patient-contact component of a neonatal hypothermia cot assembly intended to be used during induction of mild hypothermia in a neonatal patient by allowing heat transfer away from the recumbent patient. It is typically gel-filled and intended to be placed between the patient and a cooled heat-retention pad. This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Neonatal Hypothermia Cot Heat-Conduction Mattress
The Neonatal Hypothermia Cot Heat-Conduction Mattress is a specialized, non-sterile, patient-contact device designed to assist in the management of mild hypothermia in neonates. As a reusable, gel-filled mattress component placed between a neonate and a cooled heat-retention pad, it plays a critical role in pediatric and neonatology care. Given its intended use and interaction with vulnerable patients, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is mandatory before market entry.
CDSCO Regulatory Framework for Neonatal Hypothermia Cot Heat-Conduction Mattress
This device falls under the Class B medical devices classification according to the CDSCO’s risk-based categorization. Class B devices are considered low to moderate risk, requiring manufacturers to obtain an MD5 manufacturing license issued by the State Licensing Authority. The regulatory framework mandates adherence to quality, safety, and performance standards defined under the Medical Device Rules, 2017.
Risk Classification and License Requirements for Class B Devices
- Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Application Platform: CDSCO MD Online Portal
Class B devices like the neonatal hypothermia mattress require a stringent process involving testing, documentation, and an audit by a CDSCO-notified body before license approval.
Manufacturing License Process (MD5) for Neonatal Hypothermia Cot Heat-Conduction Mattress
- Apply for Test License (Form MD13): The first step involves obtaining a test license which allows sample testing of the device. This phase usually takes about 1.5 to 2 months.
- Product Testing: The device must be tested by CDSCO-approved laboratories to verify compliance with Indian standards. Refer to the list of testing laboratories for authorized facilities.
- Documentation Preparation: Comprehensive technical files including Device Master File, Plant Master File, Risk Management File, and others are prepared.
- Apply for MD5 License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: An audit by an approved notified body is mandatory. You can check the list of notified bodies for suitable auditors.
- Resolution of Queries: Address any queries or clarifications raised by the licensing authority or auditor.
- Grant of License: Upon successful completion of all steps, the MD5 license is issued.
The entire process typically takes 3 to 4 months from the start of application to license grant.
Manufacturing License Documents Required for Class B Device
- Company Constitution and Registration Proof
- Proof of Ownership/Lease of Manufacturing Premises
- Technical Staff Qualification Certificates and Experience Details
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) – detailing design, manufacturing, and performance data. Our detailed Device Master File guide can help streamline preparation.
- Plant Master File (PMF) – describing the manufacturing environment and quality systems. Learn how to create a compliant PMF here.
- Essential Principles Checklist confirming compliance with CDSCO regulations
- Risk Management File demonstrating how risks are identified and mitigated, per best practices.
- Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certificates)
Import License Process (MD15) for Neonatal Hypothermia Cot Heat-Conduction Mattress
If you are an importer, an MD15 import license issued by the Central Licensing Authority is required. The process involves:
- Comprehensive document preparation including manufacturing license from the country of origin, free sale certificate, ISO certification, CE certificate, and local documents like wholesale license.
- Submission of application via the CDSCO MD Online Portal.
- Addressing any departmental queries.
- License grant typically takes 5 to 6 months.
Refer to our Import License Guide for detailed steps.
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
- Plant Master File
- Wholesale License issued in India
- Company Constitution documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 3 – 4 weeks |
| Manufacturing License (MD5) | 1 – 1.5 months |
| Complete Process | 3 – 4 months |
Government Fees and Costs
- Test License (MD13): Included in MD5 process
- MD5 Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
These fees are payable through the CDSCO portal during application submission.
Common Challenges and Solutions
- Delayed Testing Results: Engage with CDSCO-approved labs early and ensure sample quality.
- Incomplete Documentation: Use our expert guides to prepare comprehensive Device and Plant Master Files to avoid rejections.
- Audit Non-Compliance: Conduct internal audits and gap analyses before the notified body visit.
- Query Resolution Delays: Assign dedicated regulatory personnel to promptly address CDSCO queries.
Expert Consultation and Support
With over 25 years of experience and having assisted 500+ clients in securing CDSCO licenses, we offer end-to-end support including:
- Customized document preparation
- Liaison with notified bodies and testing labs
- Gap analysis and compliance audits
- Application submission and follow-up
Our practical insights help clients avoid common pitfalls and achieve timely approvals.
Getting Started with Your CDSCO License Application
- Register on the CDSCO MD Online Portal to create your account.
- Prepare your Test License application (Form MD13) and submit with all required documents.
- Coordinate sample testing at CDSCO-approved labs.
- Develop Device Master File and Plant Master File with attention to risk management and essential principles.
- Schedule audit with a notified body listed on the CDSCO portal.
- Submit the MD5 license application (Form MD3).
- Respond to queries promptly and prepare for the audit visit.
Starting early and maintaining clear documentation are key to success. Reach out to our expert consultants to ensure a smooth, efficient licensing journey for your neonatal hypothermia cot heat-conduction mattress.
For a deep dive into the MD5 license process, refer to our MD5 License Guide.
Embark on your regulatory compliance journey with confidence and expertise—partner with us to bring your pediatric medical device to the Indian market safely and legally.
