CDSCO License for Laparoscopic cholangiography catheter/needle
Medical Device Information
Intended Use
A sterile, flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann’s pouch) during laparoscopic cholangiography to allow injection of contrast media.
Comprehensive Guide to CDSCO Licensing for Laparoscopic Cholangiography Catheter/Needle (Class B)
As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully guided more than 500 companies in securing CDSCO licenses. In this guide, we focus on the regulatory pathway for your laparoscopic cholangiography catheter/needle, a Class B device under gastroenterology, to ensure smooth and timely market entry in India.
Introduction: Device Overview and Regulatory Importance
The laparoscopic cholangiography catheter/needle is a sterile, flexible, single-lumen device designed for puncturing the gallbladder neck (Hartmann’s pouch) during laparoscopic cholangiography. This procedure facilitates the injection of contrast media for biliary tract visualization. Given its invasive use and critical application, the device falls under Class B risk category as notified by CDSCO (Notification 29/Misc./03/2020-DC (182), dated 27.09.2021).
Regulatory compliance with CDSCO ensures your device meets safety, quality, and efficacy standards mandated by Indian law, allowing you to manufacture or import and market the device legally.
CDSCO Regulatory Framework for Laparoscopic Cholangiography Catheter/Needle
The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. Devices are classified into four risk categories (A to D). Your device, being Class B, requires obtaining an MD5 manufacturing license issued by the State Licensing Authority.
You must complete several steps including obtaining a test license (Form MD13), product testing at CDSCO-approved laboratories, documentation submission, and a notified body audit before the final MD5 license grant.
Risk Classification and License Requirements
- Device Risk Class: B
- Applicable License: MD5 Manufacturing License (Form MD3)
- Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months
- Fees: Rs. 5000 per application + Rs. 500 per product
The classification is based on the device’s intended use and invasiveness, aligning with CDSCO’s classification rules, which you can verify in detail on the Medical Device Classification page.
Manufacturing License Process (MD5) for Class B Devices
- Apply for Test License (Form MD13): Initiate the process by applying for a test license on the CDSCO MD Online Portal. This license allows you to manufacture the device for testing purposes.
- Product Testing: Conduct product testing at a CDSCO-approved laboratory. You can find the list of authorized Testing Laboratories.
- Documentation Preparation: Prepare and compile all required documents, including technical files and quality management system documents.
- Apply for MD5 License (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
- Notified Body Audit: A notified body conducts a detailed audit of your manufacturing facility and quality system. Refer to the list of notified bodies.
- Address Queries: Respond promptly to any queries raised by CDSCO or the notified body.
- License Grant: Upon successful audit and document compliance, CDSCO grants the MD5 license.
Manufacturing License Documents Required for Laparoscopic Cholangiography Catheter/Needle
- Company Constitution Documents (e.g., incorporation certificate)
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Details of Technical Staff Qualifications
- Fire NOC and Pollution Control Board NOC
- Device Master File: Detailed design, specifications, risk management, and manufacturing process documentation (Guide to Device Master File)
- Plant Master File: Documentation describing manufacturing facilities and equipment (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with Indian medical device regulations
- Risk Management File, detailing hazard identification and mitigation strategies (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified
Import License Process (MD15) for Laparoscopic Cholangiography Catheter/Needle
For importers, the process differs slightly and is managed by the Central Licensing Authority:
- License Type: MD15 Import License (Form MD14)
- Processing Time: 5-6 months
- Fees: Depends on class, for Class B devices Rs. 2000 per site + Rs. 1000 per product
Import license applicants need to submit:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device and Plant Master Files
- Wholesale License
- Company Constitution
All applications must be submitted on the CDSCO MD Online Portal.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5-2 months |
| Product Testing | 3-4 weeks |
| Document Preparation | 2-3 weeks |
| MD5 License Application & Audit | 1-1.5 months |
| Total | Approx. 3-4 months |
It is crucial to plan for possible additional time to address audit and document queries.
Government Fees and Costs Breakdown
- Test License (MD13): Rs. 5000 (approx.)
- MD5 License Application: Rs. 5000
- Per Product Fee: Rs. 500
- Audit and Testing Costs: Variable (laboratory testing fees typically range from Rs. 20,000 to Rs. 50,000 depending on the test scope)
Budgeting for these fees upfront helps avoid delays.
Common Challenges and Solutions
- Delayed Test Reports: Partner with CDSCO-approved labs early; confirm testing capacity and timelines beforehand.
- Incomplete Documentation: Use detailed checklists and expert review to ensure completeness.
- Audit Non-Compliance: Prepare your facility and QMS thoroughly; consider pre-audit mock inspections.
- Query Resolution Delays: Respond promptly with clear, well-documented answers.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our team offers tailored consulting services, including document preparation, regulatory strategy, and audit readiness support specifically for Class B devices like your laparoscopic cholangiography catheter/needle. Leveraging our experience can dramatically reduce processing time and increase approval success rates.
Getting Started with Your CDSCO License Application
- Register on the CDSCO MD Online Portal: Begin by creating an account on the CDSCO MD Online Portal.
- Gather Required Documents: Collect all technical, legal, and quality documents as per the checklist.
- Apply for Test License (Form MD13): This is your entry point to start manufacturing for testing.
- Identify Testing Laboratory: Choose a CDSCO-approved testing laboratory early to avoid bottlenecks.
- Prepare for Audit: Schedule and prepare for the notified body audit by ensuring QMS and facility compliance.
By following these steps diligently and leveraging expert advice, you can successfully navigate the CDSCO licensing process for your laparoscopic cholangiography catheter/needle and bring your product to the Indian market with confidence.
For more detailed guidance, refer to our MD5 License Guide and feel free to contact our expert team for personalized assistance.
