CDSCO License for Open infant incubator

Comprehensive Guide to CDSCO Licensing for Open Infant Incubators (Class C Medical Device)

As a specialized device within pediatrics and neonatology, the open infant incubator plays a crucial role in intensive care for infants requiring immediate access and multi-therapy support. Unlike closed incubators, this device offers low side walls and no enclosing top, supporting overhead heating lamps, oxygen therapy, suction, and infusion systems. Given its complexity and critical application, the open infant incubator is classified as a Class C medical device under CDSCO regulations, necessitating a thorough and stringent licensing process.

With over 25 years of experience and having successfully guided 500+ companies through CDSCO licensing, we provide you with a detailed roadmap designed specifically for your open infant incubator to ensure smooth regulatory compliance and timely market entry in India.

CDSCO Regulatory Framework for Open Infant Incubators

The Central Drugs Standard Control Organization (CDSCO) oversees the approval and licensing of medical devices in India. For devices like the open infant incubator, which falls under Class C risk classification, the licensing authority is central, and the process is more rigorous compared to Class A or B devices. The regulatory framework mandates compliance with safety, performance, quality management systems (ISO 13485:2016), and clinical evaluation, aligned with the Medical Device Rules (MDR) 2017.

You can track your application and submit documents via the CDSCO MD Online Portal.

Risk Classification and License Requirements for Open Infant Incubators

• Risk Class: C (Moderate to High Risk)
• License Type: MD9 Manufacturing License
• Regulatory Body: Central Licensing Authority (CDSCO Headquarters)

Class C devices require comprehensive documentation, product testing from government-approved laboratories, and an audit by CDSCO inspectors.

For more on medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process for MD9 (Class C Devices)

The manufacturing license for your open infant incubator follows these steps:

1. Test License (Form MD13): Obtain a test license first to manufacture limited quantities for testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Submit device samples to CDSCO-approved testing laboratories for safety and performance evaluation. The list of Testing Laboratories is available for reference.
3. Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System documents.
4. Application Submission (Form MD7): File the manufacturing license application for MD9 via the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct a thorough audit of your manufacturing facility and quality systems.
6. Queries and Resolution: Address any queries or deficiencies raised during the audit or document review.
7. License Grant (Form MD9): Upon successful completion, the manufacturing license is granted.

Detailed guidance on the MD9 license process can be found in our MD9 License Guide.

Manufacturing License Documents Required for Open Infant Incubators

Your application must include the following documents:

• Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Design, manufacturing processes, and specifications. Learn more in our Device Master File guide.
• Plant Master File (PMF): Facility layout, equipment, and production flow. Reference our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File documenting hazard analysis and mitigation strategies. See our Risk Management guide.
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification and procedures)

Import License Process (MD15) for Open Infant Incubators

If you plan to import open infant incubators, an Import License (MD15) is mandatory. The process includes:

• Document compilation (including existing Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificates)
• Application submission via Form MD14 on CDSCO portal
• Review and queries resolution
• License grant

The import license process takes approximately 5-6 months. More details are available in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• Application Fee: ₹50,000 per application
• Product Fee: ₹1,000 per product (each variant/model of open infant incubator)

Additional costs to budget for include:

• Testing laboratory fees (varies by lab and test scope)
• Notified body audit fees
• Documentation preparation and consultancy services (if applicable)

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or insufficient device testing.

Solution: Engage experienced consultants early to prepare a comprehensive Device Master File, Risk Management File, and ensure testing is performed at CDSCO-approved labs.

Challenge: Non-compliance findings during CDSCO audit.

Solution: Conduct internal pre-audits and corrective actions before CDSCO inspections. Select notified bodies with proven expertise.

Challenge: Complexities in understanding regulatory updates.

Solution: Stay updated with CDSCO notifications and circulars. Our team provides ongoing regulatory intelligence and training.

Expert Consultation and Support

Navigating the regulatory landscape for Class C medical devices like open infant incubators requires specialized expertise. Our team has facilitated over 500 successful CDSCO licenses by providing:

• End-to-end regulatory strategy and dossier preparation
• Gap analysis and compliance audits
• Liaison with CDSCO authorities and notified bodies
• Training on MDR compliance and risk management

Partnering with experts significantly reduces approval timelines and mitigates risks of application rejection.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm the Class C status of your open infant incubator using the CDSCO Medical Device Classification tool.
2. Preliminary Testing: Apply for your test license (MD13) via the CDSCO MD Online Portal.
3. Select Testing Labs: Choose from the list of CDSCO-approved testing laboratories to conduct required product evaluations.
4. Compile Documentation: Prepare your Device Master File, Plant Master File, Risk Management File, and all supporting documents.
5. Application Submission: Complete and submit the MD9 manufacturing license application (Form MD7) through the CDSCO portal.
6. Prepare for Audit: Coordinate with CDSCO inspectors for your facility audit and ensure compliance readiness.
7. Respond Promptly: Address any queries or clarifications from CDSCO to avoid delays.

Embarking on this process with thorough preparation and expert guidance ensures your open infant incubator meets Indian regulatory standards efficiently and enters the market without avoidable hurdles. For personalized support, comprehensive documentation templates, and audit readiness assessments, contact our regulatory consultancy team.

Your journey to CDSCO approval starts here — submit your application confidently through the CDSCO MD Online portal.