CDSCO License for Haemodialysis system plasma filtration unit
Medical Device Information
Intended Use
An electrically-powered integral unit of a haemodialysis system that allows for the removal of plasma from the blood and the infusion of an equal amount of plasma replacement solution to the blood.
Expert Guide to CDSCO Licensing for Haemodialysis System Plasma Filtration Units (Class C)
As a critical component in nephrology and renal care, the Haemodialysis System Plasma Filtration Unit plays a vital role in plasma exchange therapies. Given its complex function — electrically powered plasma removal and replacement — this device is classified as Class C under the CDSCO regulatory framework. Compliance with Indian regulations is essential to ensure patient safety and market access.
With over 25 years of experience and having supported 500+ companies through the CDSCO licensing journey, we provide you with a detailed, practical roadmap to secure your MD9 manufacturing license or import license for your Class C haemodialysis plasma filtration unit.
CDSCO Regulatory Framework for Haemodialysis System Plasma Filtration Units
The CDSCO regulates medical devices under the Medical Device Rules 2017, classifying devices based on risk and intended use. Your haemodialysis plasma filtration unit falls under Class C due to its invasive nature and critical patient impact.
The device is notified under reference 29/Misc./03/2020-DC (143) dated 13.9.2021, mandating strict regulatory compliance for manufacturing and importation.
Risk Classification and License Requirements for Class C Devices
- Risk Class: C (Moderate to High Risk)
- Licensing Authority: Central Licensing Authority (CDSCO)
- Required License: MD9 Manufacturing License (Application Form MD7) or MD15 Import License (Form MD14)
Class C devices require a comprehensive audit by CDSCO inspectors and rigorous product testing to ensure conformance.
Manufacturing License Process for Class C Haemodialysis Plasma Filtration Units (MD9 License)
The manufacturing license pathway for Class C devices involves several sequential steps:
Apply for a Test License (Form MD13): Before full licensing, you must obtain a test license to manufacture the device for testing purposes. This process typically takes 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-approved government laboratories to validate device safety and performance. Refer to the CDSCO list of testing laboratories for approved facilities.
Document Preparation: Prepare detailed technical documentation including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
Submit MD9 License Application (Form MD7): Upload all documents through the CDSCO MD Online Portal.
CDSCO Inspection and Audit: CDSCO inspectors conduct a thorough audit of your manufacturing site and quality systems.
Address Queries: Respond promptly to any queries from CDSCO to avoid delays.
License Grant: Upon satisfactory review, the MD9 license is granted.
The entire process from test license application to grant of manufacturing license typically spans 4 to 5 months.
Manufacturing License Documents Required for MD9
For your haemodialysis plasma filtration unit, the following documents are mandatory:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Documents of Technical Staff
- Fire Safety and Pollution Control NOCs
- Detailed Device Master File describing device design, components, and specifications (Device Master File Guide)
- Plant Master File outlining manufacturing processes and quality controls (Plant Master File Guide)
- Essential Principles Checklist compliance
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
- Test Reports from CDSCO-approved labs
- Device Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 compliance preferred)
Import License Process for Haemodialysis Plasma Filtration Units (MD15 License)
If you plan to import this Class C device, the process is managed by CDSCO Central Licensing Authority as follows:
Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
Submit MD15 Application (Form MD14): File the application online via the CDSCO MD Online Portal.
Queries and Clarifications: Respond timely to any departmental queries.
License Issuance: Expect license grant within 5 to 6 months.
Notably, test licenses are not required for imports but documentation must be thorough and verifiable.
Import License Documents Required for MD15
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certificate
- CE Certificate or equivalent conformity certificate
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Manufacturing License (MD9) | 4 to 5 months (including test license) |
| Import License (MD15) | 5 to 6 months |
Proactive preparation and prompt responses can significantly reduce delays.
Government Fees and Costs
MD9 Manufacturing License:
- Application Fee: Rs 50,000
- Per Product Fee: Rs 1,000
MD15 Import License:
- Class C & D: Rs 3,000 per site
- Rs 1,500 per product
Test License (MD13): Fees vary by state authority; typically included in overall process cost.
Budgeting for testing, audit facilitation, and document preparation is essential.
Common Challenges and Practical Solutions
- Delays in Test Laboratory Scheduling: Book slots early at government-approved labs to avoid bottlenecks.
- Incomplete Documentation: Use comprehensive checklists and templates to ensure all documents, including Device and Plant Master Files, are complete.
- Audit Readiness: Conduct internal mock audits to prepare for CDSCO inspections.
- Query Management: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries, minimizing processing time.
Expert Consultation and Support
Navigating CDSCO’s regulatory landscape for Class C devices like your haemodialysis plasma filtration unit demands expertise. We offer end-to-end support:
- Document preparation and review
- Liaison with CDSCO and notified bodies
- Audit readiness training
- Timely application submissions via the CDSCO MD Online Portal
Our proven track record ensures your project stays on schedule and compliant.
Getting Started with Your CDSCO License Application
Classify Your Device: Confirm your device’s Class C status and review specific regulatory guidelines.
Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to begin manufacturing for testing.
Engage Accredited Testing Labs: Schedule product testing early to avoid delays.
Prepare Comprehensive Documentation: Leverage expert templates for Device and Plant Master Files.
Submit Manufacturing License Application (MD9): After successful testing, file Form MD7.
Prepare for CDSCO Audit: Ensure your facility and QMS are audit-ready.
Respond to Queries Promptly: Maintain clear communication with CDSCO officials.
Plan for Import Licensing if Applicable: Gather required international certifications and licenses.
By following these actionable steps and leveraging our expertise, your haemodialysis system plasma filtration unit can achieve timely CDSCO approval, enabling access to the growing Indian nephrology market.
For personalized guidance, connect with our regulatory specialists today and transform your regulatory challenges into business opportunities.
