CDSCO License for Hemodialysis Catheter (Long Term )
Medical Device Information
Intended Use
A dialysis catheter is a catheter used for exchanging blood to and from the hemodialysis machine from the patient. The dialysis catheter contains two lumens: Venous. Arterial
Comprehensive Guide to CDSCO Licensing for Hemodialysis Catheter (Long Term) – Class C Medical Device
Hemodialysis catheters are critical lifesaving devices used to facilitate blood exchange during hemodialysis treatment. Specifically designed with dual lumens—venous and arterial—these catheters enable efficient blood flow between the patient and the dialysis machine. Given their invasive nature and high risk profile, Hemodialysis Catheters are categorized as Class C medical devices under Indian regulations, requiring stringent compliance with the Central Drugs Standard Control Organization (CDSCO) licensing framework.
With over 25 years of experience assisting 500+ manufacturers and importers, we provide an in-depth roadmap to navigating the CDSCO licensing process for Hemodialysis Catheters, helping you bring your product swiftly and compliantly to the Indian market.
CDSCO Regulatory Framework for Hemodialysis Catheters
In India, medical devices fall under the purview of the Medical Device Rules (MDR) 2017, enforced by CDSCO. Hemodialysis Catheters are specifically notified as medical devices under Notification No. 29/Misc/3/2017-DC dated 06.06.2018.
As a Class C device, these catheters demand central licensing authority approval. The CDSCO mandates compliance with safety, efficacy, and quality standards through a structured licensing and audit process.
For detailed medical device classification, manufacturers can refer to the Medical Device Classification guide.
Risk Classification and License Requirements for Hemodialysis Catheters
Class C devices represent moderate-to-high risk medical devices. Hemodialysis catheters fall under this category due to their direct contact with blood and long-term implantation.
License requirements include obtaining an MD9 manufacturing license for Indian manufacturers or an MD15 import license for importers. Both require comprehensive technical documentation, product testing from government-approved laboratories, and regulatory audits.
Manufacturing License Process for Hemodialysis Catheters (MD9 License)
The MD9 license is granted by the CDSCO Central Licensing Authority and typically takes 4-5 months from start to finish. The process involves:
Test License Application (Form MD13): Apply for a test license to manufacture the device for testing purposes. This stage takes approximately 1.5 to 2 months.
Product Testing: Submit samples to government-approved testing laboratories. Testing validates compliance with Indian standards and Essential Principles.
Documentation Preparation: Compile mandatory documents including Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) certificates, and product labeling.
License Application (Form MD7): Submit the manufacturing license application online via the CDSCO MD Online Portal.
Audit by CDSCO Inspectors: CDSCO conducts a thorough audit of manufacturing premises, QMS, and technical files.
Query Resolution: Address any observations or deficiencies raised by auditors or the CDSCO.
License Grant (Form MD9): Upon successful completion, the license is granted, authorizing commercial manufacture.
Manufacturers can consult our detailed MD9 License Guide for step-by-step assistance.
Manufacturing License Documents Required for Hemodialysis Catheters
The key documents required for MD9 license application include:
- Company Incorporation Certificate and Constitution
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Details of Technical Staff
- Fire NOC and Pollution Control Board Clearance
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities and equipment (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance requirements
- Risk Management File outlining hazard analysis and mitigation strategies (Risk Management)
- Test Reports from CDSCO-approved laboratories (Testing Laboratories)
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification recommended)
Import License Process for Hemodialysis Catheters (MD15 License)
For importers, the MD15 license is mandatory to legally import Class C devices into India. The process generally spans 5-6 months and involves:
Document Preparation: Assemble all relevant documents, including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, and CE Certificate.
License Application (Form MD14): Submit the application online through the CDSCO MD Online Portal.
Review and Query Resolution: CDSCO evaluates the submission and may request clarifications.
License Grant (Form MD15): Upon approval, the import license is issued.
Refer to our comprehensive Import License Guide for detailed steps.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate issued by the regulatory authority of the exporting country
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution and other corporate documents
Timeline and Processing Duration for Hemodialysis Catheters
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 month |
| License Application & Audit | 1.5 – 2 months |
| Total for MD9 License | 4 – 5 months |
| Import License (MD15) | 5 – 6 months |
Planning your timelines with buffer periods for query resolution is essential for a smooth licensing journey.
Government Fees and Costs for Hemodialysis Catheter Licensing
MD9 Manufacturing License Fees:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
MD15 Import License Fees:
- Site Fee: USD 3,000
- Per Product Fee: USD 1,500
Additional costs include testing fees charged by government-approved labs, audit fees charged by notified bodies, and internal costs for document preparation and QMS implementation.
Common Challenges and Solutions in Licensing Hemodialysis Catheters
Challenge: Delays in product testing due to sample non-compliance.
- Solution: Engage with CDSCO-approved testing laboratories early and ensure sample quality meets prescribed standards.
Challenge: Audit non-conformities related to manufacturing practices.
- Solution: Implement robust QMS aligned with ISO 13485 and maintain meticulous documentation.
Challenge: Incomplete or inconsistent technical documentation.
- Solution: Utilize expert consultation to prepare comprehensive Device and Plant Master Files, risk management files, and essential principles checklists.
Challenge: Resolving queries efficiently during the application review.
- Solution: Maintain open communication channels with CDSCO and respond promptly with detailed, evidence-backed explanations.
Expert Consultation and Support for Hemodialysis Catheter Licensing
Our seasoned regulatory consultants bring over two decades of experience, having successfully navigated the CDSCO licensing landscape for over 500 medical device companies. We offer:
- Customized gap analysis and readiness assessments
- End-to-end dossier preparation and submission support
- Coordination with notified bodies and testing laboratories
- Audit preparedness and compliance training
- Post-approval support including license renewals and variations
Engage with us early in your product development cycle to streamline your regulatory pathway.
Getting Started with Your CDSCO License Application for Hemodialysis Catheters
Classify Your Device: Confirm your device as Class C under CDSCO guidelines.
Obtain Test License (If Manufacturing): Apply for Form MD13 on the CDSCO MD Online Portal.
Arrange Product Testing: Coordinate sample testing at approved laboratories.
Prepare Documentation: Develop Device Master File, Plant Master File, Risk Management File, and QMS documentation.
Submit Manufacturing or Import License Application: Depending on your operation, submit Form MD7 (manufacturing) or Form MD14 (import) via the CDSCO portal.
Audit and Inspection: Prepare for and facilitate CDSCO inspections.
Address CDSCO Queries Promptly: Respond with thorough documentation.
Receive License and Commence Commercial Activity: Once granted, maintain compliance with post-market surveillance and reporting requirements.
For comprehensive support and to expedite your licensing process, contact our expert team today.
By adhering closely to the regulatory framework and leveraging expert guidance, manufacturers and importers of Hemodialysis Catheters can successfully meet CDSCO requirements and ensure timely market access in India.
