CDSCO License for Paediatric cardiopulmonary bypass cannula
Medical Device Information
Intended Use
A sterile tube intended to be used during open heart surgery on a paediatric patient (e.g., neonatal, infant) to access the arterial or venous vasculature surrounding the heart (i.e., intended for both venous and arterial access), to serve as a channel intended to be connected to an extracorporeal circuit for the transport of blood to or from a cardiopulmonary bypass system (heart-lung machine) circuit where the blood is pumped and oxygenated. It is typically a reinforced polymer tube which may include accessories/devices dedicated to introduction/function (e.g., introducer/connector). This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Paediatric Cardiopulmonary Bypass Cannula
Paediatric cardiopulmonary bypass cannulae are critical medical devices used in open heart surgeries for neonates and infants. These sterile, single-use polymer tubes facilitate arterial and venous blood access during cardiopulmonary bypass, ensuring safe and effective circulation through heart-lung machines. Given their life-sustaining role and complexity, these devices fall under Class C risk classification as per the CDSCO framework, requiring stringent regulatory compliance to ensure safety and efficacy.
CDSCO Regulatory Framework for Paediatric Cardiopulmonary Bypass Cannula
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India, aligning with the Medical Device Rules 2017. Devices like paediatric cardiopulmonary bypass cannula are regulated under Class C due to moderate to high risk, necessitating a centralized licensing approach via the CDSCO Central Licensing Authority.
Risk Classification and License Requirements
Paediatric cardiopulmonary bypass cannulae are categorized as Class C devices, reflecting their moderate to high risk. Under the Medical Device Rules, Class C devices require an MD9 manufacturing license (Form MD7) if manufactured domestically, or an MD15 import license (Form MD14) for imported devices.
- Class C Device: MD9 license for manufacturing
- Class C Device: MD15 license for import
For detailed classification guidance, manufacturers can refer to the Medical Device Classification resource.
Manufacturing License Process (MD9) for Class C Devices
Obtaining an MD9 manufacturing license for a paediatric cardiopulmonary bypass cannula involves a structured process:
- Test License (Form MD13): Initially, a test license is mandatory to conduct product testing. This stage takes approximately 1.5 to 2 months.
- Product Testing: Samples must be tested at CDSCO-recognized laboratories. Refer to the Testing Laboratories list for authorized facilities.
- Document Preparation: Compile all required documents, including technical, quality, and safety files.
- Application Submission: Submit the MD9 application (Form MD7) via the CDSCO MD Online Portal for central authority review.
- Inspection & Audit: CDSCO inspectors conduct a thorough audit of manufacturing facilities and quality systems.
- Query Resolution: Address any queries or observations raised during the audit.
- License Grant: Upon satisfactory review, the MD9 license is granted.
The total timeline for this process is approximately 4 to 5 months.
Manufacturing License Documents Required
For the paediatric cardiopulmonary bypass cannula, manufacturers must submit a comprehensive dossier including:
- Company constitution documents
- Proof of ownership or lease of manufacturing premises
- Details of technical and quality assurance staff
- Fire and pollution NOCs
- Device Master File (DMF) detailing device specifications, manufacturing process, and design controls (see our Device Master File Guide)
- Plant Master File outlining manufacturing environment and quality systems (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian standards
- Risk Management File documenting hazard analyses and mitigation strategies (Risk Management)
- Test reports from accredited laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 certification
Import License Process (MD15) for Paediatric Cardiopulmonary Bypass Cannula
For importers, the MD15 license is essential to legally bring Class C devices into India. The process steps include:
- Document Compilation: Prepare required documents, including manufacturing license from country of origin, Free Sale Certificate, ISO certification, CE certificate, Device and Plant Master Files.
- Application Submission: Submit MD15 application (Form MD14) on the CDSCO MD Online Portal.
- Query Resolution: Respond to any clarifications sought by the licensing authority.
- License Issuance: Upon approval, the MD15 import license is granted.
This process typically takes 5 to 6 months.
Import License Documents Required
Importers must provide:
- Valid manufacturing license from the country of origin
- Free Sale Certificate demonstrating product commercialization abroad
- ISO 13485:2016 Quality Management System certification
- CE Certificate or equivalent certification
- Device Master File and Plant Master File
- Wholesale license or distribution authorization in India
- Company constitution and address proof
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Application Submission & Review | 1 month |
| Inspection & Audit | 1 month |
| Query Resolution | 2 - 3 weeks |
| Total Manufacturing License | 4 - 5 months |
| Total Import License | 5 - 6 months |
Government Fees and Costs
For Class C paediatric cardiopulmonary bypass cannula manufacturing license (MD9):
- Application fee: Rs 50,000 per submission
- Product fee: Rs 1,000 per product
For import license (MD15):
- License fee per site: $3,000
- Product fee: $1,500 per product
Note that additional costs include testing fees at accredited laboratories and consultancy or audit fees.
Common Challenges and Solutions
Challenge: Delays in product testing due to sample rejection or incomplete documentation.
Solution: Engage with CDSCO-approved testing laboratories early; ensure samples meet specifications and submit complete test requests.
Challenge: Audit non-compliance due to inadequate QMS or facility standards.
Solution: Implement robust QMS aligned with ISO 13485:2016 and pre-audit your facility to address gaps.
Challenge: Query resolution delays prolonging licensing timelines.
Solution: Respond promptly and comprehensively to CDSCO queries; maintain clear communication with the licensing authority.
Expert Consultation and Support
With over 25 years of experience assisting 500+ manufacturers and importers, we offer end-to-end regulatory support for paediatric cardiopulmonary bypass cannula licensing. From dossier preparation, audit readiness, to navigating CDSCO processes, our expert consultants ensure your project stays on track and compliant.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your paediatric cardiopulmonary bypass cannula as Class C.
- Plan Testing and Documentation: Initiate product testing with CDSCO-approved labs and compile your DMF, PMF, and QMS documents.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to begin the process.
- Prepare for Audit: Align your manufacturing site and systems to regulatory expectations.
- Engage Expert Help: Consider partnering with experienced regulatory consultants to streamline application and audit phases.
For detailed guidance on the MD9 license process, refer to our comprehensive MD9 License Guide.
Navigating the CDSCO licensing process for critical Class C devices like the paediatric cardiopulmonary bypass cannula requires precision, planning, and thorough understanding of regulatory nuances. Our proven methodology and deep expertise empower you to achieve timely approvals and successfully enter the Indian market with confidence.
