CDSCO License for Infant warmer
Medical Device Information
Intended Use
A mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.
Comprehensive Guide to CDSCO Licensing for Infant Warmers (Class C Medical Device)
Infant warmers play a crucial role in pediatrics and neonatology, providing life-saving controlled heat to newborns requiring supplemental warmth. As an AC-powered mobile device equipped with infrared heating elements, infant warmers fall under Class C risk classification by CDSCO, necessitating stringent regulatory compliance. With over 25 years of experience assisting 500+ companies in successfully navigating CDSCO licensing, we offer you a detailed, step-by-step guide to secure your manufacturing and import licenses for infant warmers in India.
CDSCO Regulatory Framework for Infant Warmers
Infant warmers are governed by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, India. The CDSCO framework mandates that manufacturers and importers of Class C devices comply with specific licensing processes, testing, and audits to ensure safety and efficacy. The regulatory oversight includes risk classification, product testing at approved labs, documentation audits, and factory inspections.
To initiate your regulatory journey, all applications and correspondence are submitted through the CDSCO MD Online Portal, streamlining the process digitally.
Risk Classification and License Requirements for Infant Warmers
Based on the latest CDSCO notifications, infant warmers are classified as Class C devices due to their moderate to high risk profile involving patient safety in critical care. This classification dictates the license types:
- Manufacturing License: MD9 License (Application Form MD7) - Granted by Central Licensing Authority
- Import License: MD15 License (Application Form MD14) - Granted by Central Licensing Authority
Class C devices require rigorous documentation and compliance with quality management systems.
Manufacturing License Process (MD9) for Infant Warmers
The MD9 manufacturing license process for Class C devices like infant warmers typically spans 4 to 5 months. It involves several critical steps:
Test License (MD13): Initially, apply for a test license on Form MD13 via the CDSCO portal. This allows you to manufacture samples for testing and takes approximately 1.5 to 2 months.
Product Testing: Submit samples to CDSCO-approved testing laboratories for compliance assessment. Refer to the list of testing laboratories for authorized facilities.
Document Preparation: Prepare comprehensive dossiers including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and quality management system (QMS) documents.
License Application (Form MD7): Submit your MD9 license application through the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors conduct a factory audit verifying compliance with Good Manufacturing Practices (GMP) and QMS.
Queries and Clarifications: Address any queries raised by the department or inspectors promptly.
License Grant: Upon satisfactory audit and document compliance, the MD9 manufacturing license is issued on Form MD9.
For an in-depth walkthrough, consult our MD9 License Guide.
Manufacturing License Documents Required for Infant Warmers
Ensure your application includes the following mandatory documents:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Documents of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, components, and specifications (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File aligned with ISO 14971 standards (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions For Use (IFU)
- Quality Management System Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Infant Warmers
Importers of infant warmers must secure an MD15 import license, granted by the Central Licensing Authority. The process generally takes 5 to 6 months and proceeds as follows:
Document Compilation: Prepare all requisite documents, including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate (if applicable), Device and Plant Master Files, and wholesale license.
License Application (Form MD14): Submit your import license application through the CDSCO MD Online Portal.
Department Review: Respond swiftly to any queries or document clarifications requested by CDSCO.
License Issuance: Upon approval, the MD15 license is issued, allowing legal importation of infant warmers into India.
For more detailed guidance, refer to our Import License Guide.
Import License Documents Required for Infant Warmers
The following documents are essential for MD15 application:
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate (FSC) confirming market authorization abroad
- ISO 13485:2016 Certification
- CE Certificate or other relevant certifications
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 1 month |
| License Application Review | 1 - 1.5 months |
| Inspection and Audit | Within 1 month |
| Query Resolution | 2 - 4 weeks |
| Total MD9 License Process | 4 - 5 months |
| Import License (MD15) Process | Duration |
|---|---|
| Document Preparation | 1 month |
| Application Review | 2 - 3 months |
| Query Resolution | 1 - 2 months |
| Total MD15 License Process | 5 - 6 months |
Government Fees and Costs
MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000 per product
MD15 Import License:
- Site Fee: ₹3,000
- Per Product Fee: ₹1,500 per product
Additional costs include testing fees charged by approved laboratories (varies by test complexity) and fees for audits by notified bodies or CDSCO inspectors.
Common Challenges and Solutions
Challenge 1: Delays in test report generation can prolong the license timeline.
- Solution: Pre-select CDSCO-approved labs from the Testing Laboratories list and initiate sample testing promptly after test license approval.
Challenge 2: Incomplete documentation leading to repeated queries.
- Solution: Use comprehensive checklists, including our detailed Device Master File guide and Plant Master File guide, to ensure dossier completeness.
Challenge 3: Audit non-compliance due to gaps in GMP or QMS.
- Solution: Conduct internal audits and gap analyses before CDSCO inspection. Maintain robust QMS aligned with ISO 13485:2016.
Challenge 4: Understanding regulatory updates and notifications.
- Solution: Maintain regular monitoring of CDSCO circulars and notifications to stay compliant.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like infant warmers demands expert guidance. Our regulatory consultants bring 25+ years of experience and have successfully supported over 500 medical device companies. We assist with:
- Tailored gap analysis and compliance roadmaps
- Preparation of Device and Plant Master Files
- Coordinating sample testing with notified labs
- Application preparation and submission via CDSCO MD Online Portal
- Handling audit preparation and post-audit query resolution
Partnering with experts reduces approval timelines and mitigates risks of application rejection.
Getting Started with Your CDSCO License Application for Infant Warmers
Classify Your Device: Confirm infant warmer classification as Class C via CDSCO or use our Medical Device Classification tool.
Register on CDSCO MD Online Portal: Create your account for application submissions at CDSCO MD Online Portal.
Apply for Test License (Form MD13): Submit your initial test license application to start manufacturing samples.
Plan Testing: Coordinate with approved labs early to schedule product testing.
Prepare Documentation: Compile all mandatory documents, leveraging our expert guides for Device Master File, Plant Master File, and Risk Management.
Submit MD9 Application: After testing, apply for the manufacturing license and prepare for the audit.
For Importers: Gather foreign manufacturing licenses, FSCs, and ISO certifications to apply for MD15.
Taking these proactive steps ensures a smooth regulatory pathway for your infant warmer device in India. For personalized assistance, reach out to our seasoned regulatory experts who can guide you at every stage of the CDSCO licensing journey.
