CDSCO License for Cholangiopancreatography catheter, reusable
Medical Device Information
Intended Use
A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP).
Comprehensive Guide to CDSCO Licensing for Cholangiopancreatography Catheters (Reusable)
Navigating the regulatory landscape for medical devices in India can be challenging, especially for specialized devices like the Cholangiopancreatography catheter, reusable. This flexible catheter, classified as a Class B device under India's regulatory framework, plays a critical role in gastroenterology by facilitating endoscopic cannulation during ERCP procedures. With over 25 years of expertise and having assisted 500+ companies in securing CDSCO licenses, we provide you with a detailed, actionable roadmap to successfully register and license your device for the Indian market.
CDSCO Regulatory Framework for Cholangiopancreatography Catheters
The Central Drugs Standard Control Organization (CDSCO) governs the approval, manufacture, and import of medical devices in India. Your reusable Cholangiopancreatography catheter falls under Class B (low-moderate risk) as per the latest notifications, specifically notified under 29/Misc./03/2020-DC (182) dated 27.09.2021.
Class B devices require a manufacturing license (MD5) if produced domestically or an import license (MD15) if imported. The licensing process is overseen by the State Licensing Authority for manufacturing and the Central Licensing Authority for imports.
For comprehensive device classification details, manufacturers can refer to the Medical Device Classification guide.
Risk Classification and License Requirements for Your Device
Your reusable Cholangiopancreatography catheter is categorized as Class B under the CDSCO risk classification:
| Device Type | Risk Class | License Type | Licensing Authority | Typical Duration | Government Fee |
|---|---|---|---|---|---|
| Cholangiopancreatography Catheter | B | MD5 License | State Licensing Authority | 3-4 months | Rs 5,000 + Rs 500 per product |
This classification means you must obtain a MD5 manufacturing license via the State Licensing Authority. The process involves submission of detailed technical and quality documents, product testing, and audit by a notified body.
Manufacturing License Process (MD5) for Class B Devices
The MD5 license application process consists of several critical steps:
Test License (Form MD13): Before applying for the manufacturing license, you must obtain a test license for your catheter. This allows you to manufacture the product in limited quantities for testing purposes. The test license approval takes approximately 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved laboratories. Testing parameters include biocompatibility, mechanical integrity, sterility, and other product-specific criteria. Refer to the list of CDSCO testing laboratories for authorized centers.
Document Preparation: Compile all technical files, quality management system (QMS) documentation, and supporting documents.
License Application (Form MD3): Submit the MD5 application with all documents through the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit is conducted by a notified body to verify compliance with regulatory and quality standards. Check the list of notified bodies for authorized auditors.
Query Resolution: Address any queries raised by the licensing authority or audit team promptly.
Grant of License: Upon satisfactory review, the State Licensing Authority issues the manufacturing license on Form MD5.
For detailed guidance on the MD5 license process, see our MD5 License Guide.
Manufacturing License Documents Required for Cholangiopancreatography Catheter
When applying for your MD5 license, ensure you have the following documents ready:
- Company Constitution Documents (e.g., incorporation certificate, partnership deed)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Certificates (including biomedical engineers or medical device experts)
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailed technical specifications, design drawings, manufacturing processes. Our comprehensive Device Master File guide can help you prepare this crucial document.
- Plant Master File: Details of the manufacturing facility, equipment, and quality control processes. Learn how to create this with our Plant Master File guide.
- Essential Principles Checklist: Demonstrating compliance with Indian medical device regulations
- Risk Management File: Documented risk analysis and mitigation strategies as per ISO 14971. Our Risk Management guide offers practical insights.
- Test Reports from CDSCO Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: ISO 13485:2016 certification or equivalent
Import License Process (MD15) for Cholangiopancreatography Catheters
If you intend to import this device instead of manufacturing it locally, you must apply for an MD15 import license through the Central Licensing Authority.
Key steps include:
Document Preparation: Unlike manufacturing licenses, a test license is not mandatory for imports.
Application Submission: File the application on Form MD14 via the CDSCO MD Online Portal.
Documentation Review: The authority reviews your manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, and wholesale license.
Query Resolution: Respond to any queries raised promptly.
License Grant: Once all requirements are met, the MD15 license is issued.
Refer to our Import License Guide for detailed steps.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Certification
- CE Certificate (if device is CE marked)
- Device Master File and Plant Master File
- Wholesale license
- Company constitution documents
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 4 weeks |
| License Application & Audit | 1 - 1.5 months |
| Total for MD5 License | 3 - 4 months |
For import license (MD15), the process typically takes 5-6 months as it involves detailed scrutiny by the Central Licensing Authority.
Government Fees and Costs
For your Class B device:
MD5 Manufacturing License:
- Rs 5,000 per application
- Rs 500 per product
MD15 Import License:
- Rs 2,000 per site
- Rs 1,000 per product
Additional costs may include laboratory testing fees, notified body audit charges, and consultancy fees if you engage expert support.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Testing facilities are often backlogged. Plan and book your testing slots early with authorized labs.
Challenge 2: Incomplete Documentation
- Missing or poorly prepared Device Master Files or Risk Management Files are common reasons for query generation. Utilize expert templates and checklists.
Challenge 3: Audit Non-Compliance
- Ensure your manufacturing facility and QMS meet CDSCO standards before audit. Conduct internal audits to prepare.
Challenge 4: Query Resolution Delays
- Respond promptly and thoroughly to queries. Engage regulatory consultants if needed.
Expert Consultation and Support
With our 25+ years of experience, we have successfully guided over 500 companies through the CDSCO licensing maze. From document preparation, audit readiness, to query management, our tailored support minimizes your time-to-market and ensures compliance.
We recommend partnering with experts who understand CDSCO nuances and can streamline your MD5 or MD15 application process.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your catheter’s Class B status using the CDSCO guidelines.
Compile Core Documents: Begin assembling your Company Constitution, technical staff details, and facility ownership proofs.
Apply for Test License (MD13): Submit this first step on the CDSCO MD Online Portal.
Plan for Product Testing: Coordinate with CDSCO-approved laboratories early.
Prepare Device and Plant Master Files: Use our detailed guides to create robust documentation.
Engage a Notified Body: Schedule your audit after testing and document preparation.
Submit MD5 Application (Form MD3): Complete this on the online portal and track your application.
By following this structured approach, you can efficiently navigate the regulatory requirements for your reusable Cholangiopancreatography catheter and enter the Indian market with confidence.
For personalized assistance or to discuss your specific situation, contact our regulatory experts today.
