CDSCO License for Percuataneous Intravascular Long Term Catheter
Medical Device Information
Intended Use
The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the
Comprehensive Guide to CDSCO Licensing for Percutaneous Intravascular Long Term Catheters
Percutaneous Intravascular Long Term Catheters are critical medical devices designed to provide repeated vascular access over 30 days or more, enabling administration of fluids, medications, and nutrients. Categorized under Class C due to their moderate to high risk profile, these catheters require stringent regulatory compliance before entering the Indian market. With over 25 years of experience supporting 500+ manufacturers, we provide you with an expert roadmap to navigate the Central Drugs Standard Control Organization (CDSCO) licensing process efficiently.
CDSCO Regulatory Framework for Percutaneous Intravascular Long Term Catheters
The CDSCO governs medical device approvals in India, classifying devices based on risk and intended use. For Class C devices like Percutaneous Intravascular Long Term Catheters, the regulatory authority is centralized under CDSCO headquarters. The applicable regulatory notification is 29/Misc/3/2017-DC (292), dated 06.06.2018, which outlines specific requirements for catheters.
Compliance with CDSCO ensures patient safety, product quality, and market authorization, making the licensing process a critical step for manufacturers and importers.
Risk Classification and License Requirements for Catheters
Class C devices are moderate to high risk and include long-term invasive devices such as intravascular catheters. The licensing for these devices requires an MD9 manufacturing license or an MD15 import license depending on whether you manufacture or import the product.
- Manufacturing License: MD9 (Form MD7) issued by CDSCO Central Licensing Authority.
- Import License: MD15 (Form MD14) also issued centrally.
Understanding these classifications helps streamline your application and avoid regulatory delays.
Manufacturing License Process for Class C Devices (MD9 License)
Obtaining an MD9 license involves a structured multi-step procedure:
Test License Application (Form MD13): Initiate with a test license allowing product testing at government-approved labs. This step typically takes 1.5 to 2 months.
Product Testing: Send samples to CDSCO-recognized testing laboratories. Refer to the list of testing laboratories for accredited centers.
Documentation Preparation: Compile comprehensive dossiers, including the Device Master File and Plant Master File.
Application Submission (Form MD7): File the manufacturing license application via the CDSCO MD Online Portal with all supporting documents.
Audit by CDSCO Inspectors: A rigorous on-site audit assesses compliance with QMS, technical capabilities, and infrastructure.
Resolution of Queries: Address any observations or deficiencies raised during audit or document review.
Grant of License (Form MD9): Upon satisfactory compliance, CDSCO issues the manufacturing license.
Typically, this entire process spans 4 to 5 months.
Manufacturing License Documents Required for MD9
For Class C catheter manufacturing, the following documents must be meticulously prepared:
- Company Constitution and Registration Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire and Pollution NOCs
- Device Master File detailing product specifications and design (Device Master File Guide)
- Plant Master File with manufacturing process details (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified
Attention to detail in document preparation significantly reduces review time.
Import License Process for Class C Devices (MD15 License)
If you are an importer of Percutaneous Intravascular Long Term Catheters, the MD15 import license is mandatory. The process is as follows:
Document Preparation: Assemble the required documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO certifications, CE Mark if applicable, Device and Plant Master Files.
Application Submission (Form MD14): Submit via the CDSCO MD Online Portal.
Departmental Review and Queries: Respond promptly to any CDSCO queries.
Grant of Import License (Form MD15): Upon clearance, CDSCO grants the import license enabling market entry.
This process generally takes 5 to 6 months.
Import License Documents Required for MD15
Key documentation includes:
- Valid Manufacturing License from the country of manufacture
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution and Registration Details
Ensuring these documents are current and authentic helps prevent delays.
Timeline and Processing Duration
| License Type | Process Steps | Approximate Duration |
|---|---|---|
| MD9 (Manufacturing) | Test License + Testing + Application + Audit + Query Resolution | 4-5 months |
| MD15 (Import) | Application + Query Resolution + License Grant | 5-6 months |
Starting early with rigorous preparation can expedite approval.
Government Fees and Costs
MD9 License Fees:
- Application Fee: Rs. 50,000
- Per Product Fee: Rs. 1,000
MD15 License Fees:
- Site Fee: $3,000
- Per Product Fee: $1,500
Additional costs include product testing fees at government-approved labs and expenses related to audits and document preparation.
Common Challenges and Practical Solutions
Incomplete Documentation: Inconsistent or missing documents are the leading cause of delays. We recommend using detailed checklists and professional consultation.
Testing Delays: Selecting government-approved labs early and preparing samples in advance can mitigate long wait times.
Audit Non-Compliance: Conduct pre-audit internal assessments to ensure readiness.
Query Management: Timely and factual responses to CDSCO queries prevent application stagnation.
Our hands-on approach has helped clients overcome these hurdles efficiently.
Expert Consultation and Support
Navigating CDSCO regulations for Class C devices like Percutaneous Intravascular Long Term Catheters demands deep expertise. Our specialized team offers:
- Customized gap analysis and compliance roadmaps
- Assistance with preparation of Device Master Files, Plant Master Files, and Risk Management Documentation
- Coordination with notified bodies and testing labs
- End-to-end application filing and follow-up through the CDSCO MD Online Portal
Partnering with experienced consultants reduces regulatory risk and accelerates market entry.
Getting Started with Your CDSCO License Application
Classify Your Device: Confirm your catheter’s classification as Class C by consulting the Medical Device Classification.
Prepare Test License: Apply for Test License (Form MD13) to initiate product testing.
Identify Testing Labs: Choose from the official list of testing laboratories early for timely analysis.
Document Compilation: Begin assembling core technical and quality documents, leveraging our Device Master File and Plant Master File guides.
Engage Notified Bodies: For audits, reference the Notified Bodies List to select qualified auditors.
Submit Application: Use the CDSCO MD Online Portal for application submission and tracking.
Track and Respond: Monitor application status closely and respond promptly to any CDSCO queries.
By following these targeted steps, manufacturers and importers can confidently achieve CDSCO licensing, ensuring compliance and successful market access for Percutaneous Intravascular Long Term Catheters in India.
