CDSCO License for Infant incubator warming hood
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A heating element positioned above an incubator's chamber designed to provide warmth for the chamber's environment. It may be used instead of or as a supplement to the incubator's internal heating system, and may be built onto or be an integral part of the incubator hood.
Comprehensive Guide to CDSCO Licensing for Infant Incubator Warming Hood (Class A)
Introduction: Understanding the Infant Incubator Warming Hood and Its Regulatory Importance
The Infant Incubator Warming Hood is a critical pediatric medical device designed to maintain optimal warmth within an incubator chamber. Positioned above the incubator, it ensures a controlled thermal environment essential for neonatal care, either supplementing or replacing the incubator’s internal heating system. Given its direct impact on vulnerable neonates, regulatory compliance is paramount to ensure safety and efficacy.
In India, the Central Drugs Standard Control Organization (CDSCO) regulates this device under Risk Class A, signifying a low-risk device but one that still requires stringent quality and safety checks. Compliance with CDSCO regulations not only ensures market access but also builds trust with healthcare providers and end-users.
CDSCO Regulatory Framework for Infant Incubator Warming Hood
As per the CDSCO notification (File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021), Infant Incubator Warming Hood falls under Class A devices for Pediatrics and Neonatology. This means manufacturers must obtain an MD5 manufacturing license through the State Licensing Authority. For importers, an MD15 import license from the Central Licensing Authority is mandatory.
The regulatory framework emphasizes compliance with the Medical Device Rules, 2017, adherence to Essential Principles of Safety and Performance, and implementation of a Quality Management System (QMS), generally ISO 13485:2016.
Risk Classification and License Requirements for Infant Incubator Warming Hood
- Risk Class: A (Low Risk)
- License Type: MD5 Manufacturing License (Form MD3) for domestic manufacturers
- Licensing Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months
- Associated Fees: Rs. 5,000 per application + Rs. 500 per product
For imports, the MD15 license is applicable with a longer processing time and higher fees.
You can verify the device classification and requirements in detail through our Medical Device Classification resource.
Manufacturing License Process for Infant Incubator Warming Hood (MD5)
Obtaining the MD5 license involves a systematic process:
- Test License Application (Form MD13): Initiate with a test license application, which typically takes 1.5 to 2 months. This allows you to manufacture the device for testing purposes.
- Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Refer to the list of testing laboratories for authorized facilities.
- Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System details.
- License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: A mandatory audit conducted by a notified body from the official Notified Bodies List to verify compliance.
- Resolution of Queries: Respond promptly to any queries from CDSCO or the notified body to avoid delays.
- Grant of License: Upon successful review and audit, the MD5 license is granted.
Manufacturing License Documents Required for Infant Incubator Warming Hood
Manufacturers must submit the following documents:
- Company Constitution and Incorporation Certificates
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File: Detailed design and manufacturing information (Device Master File guide)
- Plant Master File: Manufacturing environment and quality controls (Plant Master File guide)
- Essential Principles Checklist
- Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management resources)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System documents (preferably ISO 13485:2016 certification)
Import License Process for Infant Incubator Warming Hood (MD15)
For companies importing Infant Incubator Warming Hoods, an MD15 license from the Central Licensing Authority is required. The process differs slightly:
- Document Preparation: Gather all required certifications including Free Sale Certificate, ISO 13485:2016, CE Certificate, and manufacturer’s MD5 license.
- Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
- Query Resolution: Address queries raised by the CDSCO licensing team.
- License Grant: Upon satisfactory review, the MD15 import license is issued.
No test license or audit by a notified body is required for imports, but documentation scrutiny is rigorous.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate issued by the regulatory authority in the exporting country
- ISO 13485:2016 Quality Management System certification
- CE Certificate or equivalent safety certification
- Device Master File and Plant Master File
- Wholesale License for importers
- Company Constitution and incorporation documents
For detailed guidance, refer to our Import License Guide.
Timeline and Processing Duration
| License Type | Process Steps | Typical Duration |
|---|---|---|
| Test License (MD13) | Application, testing license grant | 1.5 to 2 months |
| Product Testing | Conducted at CDSCO-approved labs | 1 to 1.5 months |
| Manufacturing License (MD5) | Document submission, audit, query resolution | 1.5 to 2 months |
| Total Duration | From test license to final MD5 license | 3 to 4 months |
Import license (MD15) typically takes 5 to 6 months, given the rigorous document review process.
Government Fees and Costs
For Infant Incubator Warming Hood (Class A):
- MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
- Test License (MD13): Included in above process; no separate fee listed but typically part of the application
For Import License (MD15):
- Site Fee: Approximately $1,000 per site
- Product Fee: $50 per product
Additional costs may include notified body audit fees, product testing charges at government-approved labs, and consultancy fees if you opt for expert assistance.
Common Challenges and Solutions
- Delayed Test Reports: Testing at approved labs can bottleneck your timeline. We recommend pre-booking lab slots and engaging with multiple labs for backup.
- Incomplete Documentation: Missing or inconsistent files often cause delays. Utilize checklists and expert document reviews before submission.
- Audit Non-Compliance: Preparedness is key. Conduct internal audits and gap assessments before notified body visits.
- Query Management: Timely and clear responses to CDSCO queries expedite approvals.
Our experience with over 500 companies highlights that proactive planning and compliance readiness significantly reduce licensing cycle times.
Expert Consultation and Support
With over 25 years of regulatory consultancy experience, we have successfully guided hundreds of manufacturers and importers of pediatric devices like the Infant Incubator Warming Hood through the CDSCO licensing maze. Our services include:
- End-to-end license application management
- Documentation preparation and review
- Coordination with notified bodies and testing laboratories
- Regulatory strategy and compliance training
Feel free to reach out to leverage our expertise for a hassle-free licensing journey.
Getting Started with Your CDSCO License Application for Infant Incubator Warming Hood
- Assess Your Device Classification: Confirm your device’s class and regulatory requirements via CDSCO and official notifications.
- Prepare Your Test License Application: Initiate the MD13 test license application on the CDSCO MD Online Portal.
- Plan Product Testing: Identify and schedule your product testing at one of the CDSCO-approved labs.
- Compile Required Documentation: Gather company, technical, and product-specific documents, referencing our detailed guides on Device and Plant Master Files.
- Engage a Notified Body: Select a notified body from the official list and prepare for the audit.
- Submit Your Manufacturing License Application: File Form MD3 through the CDSCO portal once all prerequisites are complete.
- Monitor Application Progress: Respond promptly to any queries and prepare for the audit.
Taking these practical steps will position you strongly for successful licensing of your Infant Incubator Warming Hood in India. For tailored support, connect with our regulatory experts today.
