CDSCO License for Warming infant bed, adjustable
Medical Device Information
Intended Use
A mains electricity (AC-powered) bed specifically designed for a newborn, sick, or premature baby that requires additional heating provided by a heating pad system. It is typically ergonomically designed for the attending/nursing staff or parents and the motorized mechanism is used to electrically adjust the height and possibly tilt the bed to provide better access to the baby. 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 (Adjustable) – Class C Medical Device
Manufacturers and importers of the Warming Infant Bed, adjustable, a Class C medical device used in pediatrics and neonatology, face rigorous regulatory requirements before entering the Indian market. This mains electricity-powered bed is specially designed to provide thermal support and ergonomic accessibility for newborns, including premature or sick infants, in maternity and neonatal care units.
With over 25 years of consultancy expertise and 500+ successful CDSCO license applications, we provide a detailed, practical roadmap to navigate the regulatory framework for this device. Our insights cover everything from risk classification to government fees, timelines, and common challenges.
CDSCO Regulatory Framework for Warming Infant Bed (Class C)
The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. As per the Medical Device Rules 2017, the warming infant bed falls under Class C due to its critical role in patient support and electrical components.
Class C devices require a centralized license (MD9) issued by CDSCO, involving stringent product testing, documentation, and factory audits to ensure safety and efficacy.
Risk Classification and License Requirements
- Device: Warming Infant Bed (adjustable), mains-powered
- Risk Class: Class C
- Regulatory License: MD9 Manufacturing License (Form MD7)
- Issuing Authority: CDSCO Central Licensing Authority
- Applicable Rules: Medical Device Rules, 2017
Class C devices, such as this infant warming bed, typically have moderate to high risk due to electrical operation and direct patient contact, mandating robust quality controls.
Manufacturing License Process (MD9)
The MD9 license process involves several key steps:
Test License Application (Form MD13): Before manufacturing license, obtain a test license allowing product testing. This takes approximately 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-approved labs to verify compliance with Indian standards. Refer to the list of testing laboratories authorized by CDSCO.
Documentation Preparation: Compile comprehensive technical files, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Submit MD9 Application (Form MD7): Apply via the CDSCO MD Online Portal with supporting documents.
Audit by CDSCO Inspectors: Factory audit to assess compliance with GMP and QMS requirements.
Resolve Queries: Address any observations or queries from CDSCO or inspectors promptly.
Grant of MD9 License (Form MD9): Upon successful completion, the license is issued.
Total estimated timeline for the MD9 license is 4 to 5 months.
Manufacturing License Documents Required
For the warming infant bed Class C device, the documentation checklist includes:
- Company Constitution Documents (incorporation certificate, memorandum & articles of association)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Details (qualification and experience of key personnel)
- Fire NOC & Pollution Control Board NOC
- Device Master File (DMF): Detailed design, specifications, and manufacturing processes. Our Device Master File guide offers valuable insights.
- Plant Master File (PMF): Details of manufacturing facilities and controls. See our Plant Master File Guide for preparation tips.
- Essential Principles Checklist: Demonstrates conformity with Indian medical device essential principles.
- Risk Management File: Documentation of risk analysis and mitigation strategies. Learn more about Risk Management.
- Test Reports: From CDSCO-approved labs verifying electrical safety, thermal performance, and biocompatibility.
- Labels and Instructions for Use (IFU): Compliant with Indian regulations.
- Quality Management System (QMS) Documents: Proof of implementation of ISO 13485:2016 or equivalent.
Import License Process (MD15)
If you are an importer of the warming infant bed, the import license (MD15) is mandatory.
Document Preparation: Gather manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission: File Form MD14 on the CDSCO MD Online Portal.
Review & Queries: CDSCO reviews the application; respond to any queries.
Grant of MD15 License: License issued within 5 to 6 months.
Import License Documents Required
- Valid Manufacturing License (MD9 for Class C device)
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File & Plant Master File
- Valid Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| MD9 Application Processing | 1.5 – 2 months |
| Factory Audit & Queries | 1 month |
| Total Approximate Time | 4 – 5 months |
For the import license (MD15), anticipate 5 to 6 months.
Government Fees and Costs
| License Type | Application Fee (Rs) | Per Product Fee (Rs) |
|---|---|---|
| MD9 (Class C Device) | 50,000 | 1,000 |
| MD15 Import License | 3,000 USD/site | 1,500 USD/product |
Fees are payable online through the CDSCO portal.
Common Challenges and Solutions
Delayed Testing Reports: Engage early with CDSCO-approved labs to schedule testing and avoid bottlenecks.
Incomplete Documentation: Use comprehensive checklists and expert review to ensure all technical files and QMS documents are in place.
Audit Non-Compliance: Conduct pre-audit assessments and training for manufacturing staff.
Query Resolution Delays: Assign a dedicated regulatory expert to handle CDSCO communications swiftly.
Expert Consultation and Support
Navigating the CDSCO licensing process for Class C devices like the warming infant bed can be complex. Our team offers tailored support including:
- Preparation of Device Master File and Plant Master File
- Regulatory strategy and risk management
- Coordinating product testing and audits
- Submission and follow-up on online applications
Collaborate with consultants experienced in MD9 licenses to accelerate market entry and ensure compliance.
Getting Started with Your CDSCO License Application
Classify Your Device: Confirm Class C risk categorization using the Medical Device Classification resource.
Prepare Test License Application: Apply for Form MD13 on the CDSCO MD Online Portal to initiate testing.
Compile Documentation: Begin assembling your Device Master File, Plant Master File, risk management documents, and QMS evidence.
Schedule Product Testing: Engage with CDSCO-approved testing laboratories early to avoid delays.
Plan for Audit: Identify notified bodies or CDSCO inspectors for your factory audit and ensure readiness.
Submit MD9 Application: Once test reports are ready, submit your manufacturing license application with all supporting documents.
Monitor Application Status: Use the CDSCO portal to track progress and respond promptly to queries.
For detailed assistance, refer to our MD9 License Guide or contact our expert consultants to streamline your licensing journey.
By adhering to this structured approach and leveraging expert support, manufacturers and importers of the warming infant bed can confidently achieve CDSCO compliance, ensuring safe and timely access to the Indian healthcare market.
