CDSCO License for Conventional infant incubator
Medical Device Information
Intended Use
A mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.
Comprehensive Guide to CDSCO Licensing for Conventional Infant Incubators (Class C Medical Device)
Introduction: Conventional Infant Incubator and Its Regulatory Importance
Conventional infant incubators are critical medical devices designed to provide a controlled environment for premature and vulnerable newborns who cannot maintain their body temperature. Powered by mains electricity, these devices ensure precise temperature and humidity control through heated air or warm water mattresses, supporting neonatal care in hospital wards. Given their direct impact on infant health and safety, conventional infant incubators fall under Class C—high-risk medical devices—in India’s regulatory framework.
Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process for such devices is essential for manufacturers and importers aiming to enter the Indian market legally and efficiently. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide you with a detailed roadmap tailored specifically for conventional infant incubators.
CDSCO Regulatory Framework for Conventional Infant Incubators
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017. As a Class C device notified under File No. 29/MiscJ03/2020-DC (150) dated 23.08.2021, the conventional infant incubator requires a manufacturing license (MD9) or import license (MD15) granted by the Central Licensing Authority.
Class C devices are considered medium-to-high risk and are subjected to stringent regulatory oversight including mandatory testing, documentation, and audits to ensure patient safety and device efficacy.
Risk Classification and License Requirements for Infant Incubators
Conventional infant incubators are categorized as Class C devices due to their role in neonatal life support and the potential risk if malfunctioning. This classification mandates manufacturers and importers to obtain the following licenses:
- Manufacturing License: MD9 (Application Form MD7), issued by the Central Licensing Authority.
- Import License: MD15 (Application Form MD14), also issued by the Central Licensing Authority.
The licensing process includes pre-approval testing, detailed document submission, and inspections.
Manufacturing License Process for Conventional Infant Incubators (MD9 License)
Obtaining an MD9 manufacturing license involves multiple steps:
- Test License (MD13): Apply for a test license to conduct product testing in a CDSCO-approved laboratory. This step takes approximately 1.5 to 2 months.
- Product Testing: Send samples of the infant incubator to government-approved testing laboratories for compliance verification. Refer to the list of testing laboratories for accredited facilities.
- Documentation Preparation: Compile technical files including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- Application Submission: File the MD9 application using Form MD7 on the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO inspectors will conduct a thorough audit of manufacturing premises and quality management system.
- Query Resolution: Address any queries raised during audit or document review.
- License Grant: Upon satisfactory compliance, CDSCO issues the MD9 license.
The entire process typically spans 4 to 5 months.
For detailed guidance, our MD9 License Guide offers step-by-step instructions.
Manufacturing License Documents Required for Conventional Infant Incubators
Preparing comprehensive documentation is crucial. Key documents include:
- Company Constitution (Incorporation Certificate, MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Technical Staff (Qualification and Experience)
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File outlining specifications, design, and performance (Device Master File Guide)
- Plant Master File detailing manufacturing processes and quality systems (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File applying ISO 14971 principles (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification preferred)
Import License Process for Conventional Infant Incubators (MD15 License)
For importers, the MD15 license is mandatory. The process involves:
- Document Preparation: Assemble required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and technical files.
- Application Submission: File the import license application on Form MD14 via the CDSCO MD Online Portal.
- Query Resolution: Respond to any CDSCO queries.
- License Issuance: Upon clearance, the MD15 import license is granted.
Unlike manufacturing, no test license is required, but thorough documentation and compliance evidence are mandatory. The process generally takes about 5 to 6 months.
For further insights, see our detailed Import License Guide.
Import License Documents Required for Conventional Infant Incubators
Key documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent conformity documents
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution documents
- Detailed product specifications and labeling
Timeline and Processing Duration
| License Type | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Manufacturing License (MD9) | 4 - 5 months (including testing and audit) |
| Import License (MD15) | 5 - 6 months |
Manufacturers should plan timelines accordingly, keeping buffer periods for audit scheduling and query resolution.
Government Fees and Costs
- MD9 License: Rs 50,000 per application + Rs 1,000 per product
- MD13 Test License: Rs 5,000 per application + Rs 500 per product (initial step for manufacturing)
- MD15 Import License:
- Class C & D devices: USD 3,000 per site + USD 1,500 per product (approximate conversion applies)
Budgeting for these fees upfront and allocating resources for documentation and testing are essential for smooth approvals.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all technical files, especially Device and Plant Master Files, are thorough and updated. Use our Device Master File Guide as a resource.
- Testing Delays: Select approved labs early and schedule sample testing promptly. Refer to the list of testing laboratories.
- Audit Preparedness: Conduct mock audits focusing on quality management and manufacturing practices to avoid non-conformities.
- Query Management: Respond promptly and comprehensively to CDSCO queries to avoid unnecessary delays.
Expert Consultation and Support
With our extensive experience assisting over 500 companies, we provide end-to-end support:
- Customized gap analysis for your technical and quality documents
- Liaison with CDSCO authorities and notified bodies
- Assistance with audit preparation and training
- Streamlined application filing on the CDSCO MD Online Portal
Our proactive approach minimizes risk and accelerates your time to market.
Getting Started with Your CDSCO License Application for Conventional Infant Incubators
- Classify Your Device: Confirm Class C status using the Medical Device Classification tool.
- Prepare Technical Files: Initiate Device and Plant Master Files with detailed process and risk management documentation.
- Apply for Test License (MD13): Submit early to begin product testing.
- Engage a Notified Body: For audits, consult the list of notified bodies to select an authorized auditor.
- Submit Manufacturing or Import Application: Use the CDSCO MD Online Portal for application submission.
- Plan for Queries and Inspection: Allocate resources for timely responses and audit facilitation.
Embarking on your CDSCO licensing journey with expert guidance ensures robust compliance and market readiness for your conventional infant incubator. Contact us to leverage our 25+ years of regulatory expertise and successfully navigate India’s medical device landscape.
