CDSCO License for Warming infant bed, non-adjustable
Medical Device Information
Intended Use
A non-adjustable bed (has a fixed height and mattress platform) specifically designed for a newborn, sick, or premature baby that requires additional heating provided by a heating pad system. It is typically ergonomically designed to provide good access to the baby by the attending/nursing staff or parents. It may be equipped with features such as shelves, drawers, a canopy, and is typically used in the maternity department.
Comprehensive Guide to CDSCO Licensing for Warming Infant Bed, Non-Adjustable (Class C Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully assisted more than 500 companies, we understand the critical importance of obtaining the correct CDSCO license for your medical device. The warming infant bed, non-adjustable, designed specifically for newborns and premature babies requiring additional heating, falls under the Class C risk category and is regulated by the Central Licensing Authority in India.
In this guide, we break down the entire licensing process, timelines, costs, and documentation tailored for this pediatric and neonatology device. We aim to make your journey smooth and compliant with CDSCO requirements.
CDSCO Regulatory Framework for Warming Infant Bed (Non-Adjustable)
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Since the warming infant bed is a Class C device (moderate to high risk), it is regulated under the Medical Device Rules, 2017, requiring a Manufacturing License MD9 or an Import License MD15 before commercialization.
The device is notified under File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021, which confirms its inclusion in CDSCO’s regulatory framework.
For a detailed understanding of medical device classification, manufacturers can refer to our Medical Device Classification guide.
Risk Classification and License Requirements
- Device: Warming Infant Bed, Non-Adjustable
- Risk Class: C (moderate to high risk)
- License Type: MD9 Manufacturing License (Form MD7)
- Authority: Central Licensing Authority (CDSCO HQ)
- Process Complexity: Moderate to High
Class C devices like this require thorough testing, documentation, and inspection due to their impact on vulnerable populations such as newborns.
Manufacturing License Process (MD9 License)
The MD9 license is mandatory for manufacturing Class C and D medical devices within India. The process involves several key steps:
Test License (Form MD13): Before applying for MD9, manufacturers must obtain a test license valid for 12 months. This allows your device to undergo mandatory testing.
Product Testing: Testing must be conducted at CDSCO-approved government laboratories. You can find the list of approved Testing Laboratories here.
Documentation Preparation: Prepare comprehensive technical documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and more.
Application Submission: Submit the MD9 application (Form MD7) via the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors will conduct an on-site audit to verify compliance with QMS, manufacturing premises, and documentation.
Query Resolution: Address any observations or queries raised by inspectors or the CDSCO office.
License Grant: Upon successful compliance, CDSCO will grant the MD9 license (Form MD9).
For detailed guidance on the MD9 license process, please visit our MD9 License Guide.
Manufacturing License Documents Required
The documentation package for the warming infant bed manufacturing license includes:
- Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
- Proof of Ownership or Lease of Manufacturing Premises: Rental agreements or ownership papers
- Technical Staff Details: Qualification and experience certificates of key personnel
- No Objection Certificates: Fire NOC, Pollution Control Board NOC
- Device Master File (DMF): Detailed design, specifications, manufacturing process, and quality control measures. Our Device Master File guide provides an in-depth walkthrough.
- Plant Master File (PMF): Description of the manufacturing facility, equipment, and quality systems. Learn how to create an effective PMF here.
- Essential Principles Checklist: Confirming compliance with Indian Medical Device Rules.
- Risk Management File: Hazard analysis, risk evaluation, and mitigation strategies specific to infant warming beds. Refer to our Risk Management guide.
- Test Reports: From CDSCO-approved labs confirming device safety and performance
- Labels and Instructions for Use (IFU): Compliance with labeling regulations
- Quality Management System (QMS) Documents: ISO 13485 certification and internal procedures
Import License Process (MD15 License)
If you plan to import the warming infant bed into India, an MD15 import license is required. The process is administered by the Central Licensing Authority and includes:
Document Compilation: Unlike manufacturing licenses, no test license is needed, but you must provide certificates such as Free Sale Certificate, ISO 13485:2016, and CE marking.
Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.
Evaluation and Queries: CDSCO reviews your application and may raise queries.
License Grant: After satisfactory review, the MD15 license is granted allowing import.
Refer to our detailed Import License Guide for comprehensive instructions.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Certificate or equivalent conformity assessment
- Device Master File and Plant Master File
- Wholesale License in India (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Process Steps | Approximate Duration |
|---|---|---|
| MD9 Manufacturing License | Test License (MD13) + Testing + Audit + License Grant | 4-5 months total |
| Import License MD15 | Document Submission + Query Resolution + License Grant | 5-6 months total |
The test license stage alone takes about 1.5 to 2 months. Testing and audit processes can take an additional 2-3 months depending on compliance and query resolution speed.
Government Fees and Costs
| License Type | Fee Structure | Approximate Cost |
|---|---|---|
| MD9 License | Rs 50,000 per application + Rs 1,000 per product | Rs 51,000+ (for 1 product) |
| Test License MD13 | Included in MD9 process | Included |
| Import License MD15 | Class C/D: 1500 per product | Approximately Rs 2,25,000 + per product |
Note: Fees are exclusive of consultant charges, testing fees, and other administrative costs.
Common Challenges and Solutions
- Incomplete Documentation: Many applicants underestimate the complexity of DMF and PMF preparation. Utilize our guides and expert drafting services to avoid rejections.
- Test Lab Delays: Government-approved labs have limited capacity; schedule testing early to avoid bottlenecks.
- Audit Observations: Ensure your manufacturing facility strictly follows QMS and Good Manufacturing Practices (GMP) to pass inspections smoothly.
- Query Management: Maintain clear communication with CDSCO and provide prompt, detailed responses to queries.
Expert Consultation and Support
Navigating the CDSCO licensing process for a Class C device like the warming infant bed requires technical knowledge and regulatory expertise. Our team offers:
- End-to-end application preparation and submission
- Device and plant master file development
- Risk management and compliance documentation
- Coordination with notified bodies and testing laboratories
- Post-approval support and license renewal guidance
Our proven track record includes assisting 500+ clients to successfully obtain and maintain their CDSCO licenses.
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm your device’s Class C status using official CDSCO notifications.
- Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our expert guides.
- Obtain Test License (for manufacturing): Apply for Form MD13 on the CDSCO MD Online Portal.
- Schedule Testing: Coordinate with CDSCO-approved laboratories early to ensure timely testing.
- Engage a Notified Body: For your audit, check the list of notified bodies to select an approved auditor.
- Submit Application: File your MD9 or MD15 application through the CDSCO portal.
- Monitor and Respond: Stay proactive in responding to CDSCO queries to avoid delays.
Contact us today to leverage our extensive experience and start your regulatory journey confidently. We simplify the complex CDSCO licensing landscape so your warming infant bed reaches the Indian market efficiently and compliantly.
