CDSCO License for Kidney donor-organ preservation/transport system
Medical Device Information
Intended Use
A dedicated system designed to support and maintain a donated kidney organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient.
Comprehensive Guide to CDSCO Licensing for Kidney Donor-Organ Preservation/Transport Systems
Kidney donor-organ preservation and transport systems play a critical role in nephrology and renal care, ensuring the safe and effective transportation of donated kidneys from donor to recipient hospitals. Given the device’s life-sustaining purpose, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India is stringent and essential. With our 25+ years of experience assisting over 500 companies in obtaining CDSCO licenses, we provide a detailed, practical roadmap for manufacturers and importers aiming to enter the Indian market with this Class C medical device.
CDSCO Regulatory Framework for Kidney Donor-Organ Preservation Systems
This device falls under the category of nephrology and renal care and is notified under CDSCO Notification 29/Misc./03/2020-DC (143) dated 13.09.2021. Being a Class C device, it is subject to mid-level risk classification requiring central licensing authority approval. The CDSCO mandates compliance with the Medical Device Rules (MDR) 2017, including quality management systems, safety standards, and clinical evaluation.
Risk Classification and License Requirements for Class C Devices
The kidney donor-organ preservation/transport system is classified as a Class C medical device due to its critical role in organ transplantation and potential impact on patient health. According to the CDSCO classification, Class C devices require an MD9 Manufacturing License issued by the Central Licensing Authority. This involves a thorough evaluation including product testing, documentation review, and factory inspection.
Manufacturers must obtain:
- MD13 Test License initially for product testing
- MD9 Manufacturing License (Application Form MD7)
Importers, on the other hand, must apply for an MD15 Import License.
Manufacturing License Process (MD9) for Kidney Donor-Organ Preservation Systems
- Obtain MD13 Test License: Apply through the CDSCO MD Online Portal to get test approval, which takes approximately 1.5 to 2 months.
- Product Testing: Conduct testing at CDSCO-approved government laboratories. Refer to the list of testing laboratories for authorized facilities.
- Document Compilation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and QMS evidence.
- Application Submission: Submit the MD9 license application (Form MD7) via the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO inspectors will conduct an audit of manufacturing premises and documentation.
- Query Resolution: Address any queries or observations raised by CDSCO or the auditors promptly.
- License Grant: Upon successful compliance, the MD9 license is granted.
Manufacturing License Documents Required for MD9
- Company Constitution and Incorporation Certificates
- Proof of Premises Ownership or Lease Agreement
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and manufacturing processes (see our Device Master File guide)
- Plant Master File outlining manufacturing facilities and quality control (refer to our Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard identification and mitigation (explore our Risk Management resource)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification highly recommended)
Import License Process (MD15) for Kidney Donor-Organ Preservation Systems
Importers must apply for the MD15 license granted by the Central Licensing Authority. The process involves:
- Document Preparation: Collect all necessary documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
- Application Submission: File application via the CDSCO MD Online Portal.
- Query Resolution: Respond to any department queries promptly.
- License Approval: Grant of MD15 Import License.
Import License Documents Required
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution and Incorporation Certificates
Timeline and Processing Duration for Class C Device Licensing
| Process Step | Duration |
|---|---|
| MD13 Test License Issuance | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 month (concurrent) |
| MD9 Application Processing | 1.5 – 2 months |
| Total Time for MD9 License | Approximately 4 – 5 months |
| Import License (MD15) Processing | Approximately 5 – 6 months |
Government Fees and Costs
- MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
- MD13 Test License: Included in MD9 process
- MD15 Import License:
- Class C & D: $3,000 per site
- $1,500 per product
Note that these fees are payable through the CDSCO portal during application.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Pre-schedule testing with CDSCO-approved labs and prepare samples in advance to avoid bottlenecks.
Challenge 2: Incomplete Documentation
- Solution: Use comprehensive checklists and consult templates for Device and Plant Master Files to ensure completeness.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal audits and gap analyses before CDSCO inspection. Engage experienced notified bodies listed on the Notified Bodies List.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel to respond quickly and accurately to CDSCO queries.
Expert Consultation and Support
Navigating the CDSCO licensing process for a Class C kidney donor-organ preservation system requires specialized expertise. Our regulatory consultants bring over two decades of experience, guiding clients through testing coordination, document preparation, and audit readiness. We also assist in maintaining compliance post-license to ensure smooth market access and renewal processes.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device is Class C as per the Medical Device Classification guidelines.
- Register on CDSCO MD Online Portal: Create your account and familiarize yourself with submission procedures.
- Prepare Test Samples: Coordinate with approved labs early to avoid delays.
- Compile Documentation: Use our Device and Plant Master File guides to prepare robust files.
- Engage a Notified Body: If necessary, select an audit agency from the Notified Bodies List.
- Submit MD13 Test License Application: Begin the process with test license application.
- Plan for Audit and Inspections: Schedule internal audits and prepare your facility.
By following these actionable steps and leveraging our expert support, manufacturers and importers can successfully obtain CDSCO licensing for kidney donor-organ preservation systems, ensuring compliance and timely market entry.
For personalized assistance and detailed regulatory strategy, contact our team today.
