CDSCO License for Barium enema catheter
Medical Device Information
Intended Use
A flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area.
Comprehensive Guide to CDSCO Licensing for Barium Enema Catheters (Class B Medical Device)
As a trusted regulatory consultant with over 25 years of experience and having supported 500+ companies navigate the Indian medical device regulatory landscape, we provide you with an in-depth, practical guide to securing CDSCO licensing for your Barium Enema Catheter—a Class B gastroenterology device. This guide covers everything from regulatory framework and classification to the entire licensing process, timelines, fees, and common challenges.
Introduction: Understanding the Barium Enema Catheter and Its Regulatory Importance
A Barium enema catheter is a flexible medical device designed to introduce barium contrast medium into the lower gastrointestinal tract via the rectum for radiographic visualization. Classified as a Class B device under CDSCO regulations, it carries moderate risk and therefore requires adherence to specific regulatory controls to ensure patient safety and product efficacy.
Given the device's intended use in gastroenterology, regulatory compliance is critical not only to meet Indian standards but also to gain market trust and avoid costly delays. The Central Drugs Standard Control Organization (CDSCO) mandates stringent licensing before manufacturing or importing such devices into India.
CDSCO Regulatory Framework for Barium Enema Catheters
The CDSCO classifies medical devices based on risk into Classes A, B, C, and D. Your Barium enema catheter falls under Class B, indicating moderate risk. This classification dictates that manufacturing licenses are issued by the State Licensing Authority through an MD5 license, while import licenses are granted by the Central Licensing Authority via an MD15 license.
The relevant notification governing this device is 29/Misc./03/2020-DC (182), dated 27.09.2021.
Risk Classification and License Requirements for Class B Devices
| Device Type | Risk Class | Manufacturing License | Import License |
|---|---|---|---|
| Barium Enema Catheter | B | MD5 (Form MD3) | MD15 (Form MD14) |
- MD5 License: Required for manufacturing within India; granted by State Authority.
- MD15 License: Required for importing into India; granted by Central Authority.
Manufacturing License Process for Barium Enema Catheters (MD5 License)
The Class B device manufacturing license process is multi-phased and typically takes 3 to 4 months from start to finish.
Step-by-step process:
- Test License (Form MD13): Obtain a test license first, which allows you to manufacture samples for testing. This takes approximately 1.5 to 2 months.
- Product Testing: Submit product samples to government-approved testing laboratories for compliance verification.
- Document Preparation: Compile all required technical and regulatory documents.
- License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body listed on the CDSCO Notified Bodies List will conduct a manufacturing site audit.
- Query Resolution: Respond promptly to any queries from the CDSCO or notified body.
- License Grant (Form MD5): Upon satisfactory review, the license is granted.
Manufacturing License Documents Required for Barium Enema Catheters
- Certificate of Incorporation/Company Constitution
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) — see our detailed Device Master File guide
- Plant Master File (PMF) — learn how to prepare one in our Plant Master File guide
- Essential Principles Checklist
- Risk Management File complying with ISO 14971 principles (Risk Management resource)
- Test Reports from CDSCO-approved laboratories (List of Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Import License Process for Barium Enema Catheters (MD15 License)
To import Barium enema catheters into India, obtaining an MD15 import license is mandatory. The process, overseen by the Central Licensing Authority, takes approximately 5 to 6 months.
Steps involved:
- Document Preparation: Gather all required documentation, including your existing manufacturing license from the country of origin.
- Application Submission (Form MD14): Submit your application online through the CDSCO MD Online Portal.
- Query Resolution: Address any clarifications or additional information requests from CDSCO.
- License Grant (Form MD15): Upon successful review, the license is issued.
Import License Documents Required for Barium Enema Catheters
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent regulatory approvals
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution documents
Timeline and Processing Duration
| License Type | Approximate Duration | Key Milestones |
|---|---|---|
| MD5 Manufacturing | 3 to 4 months | Test license, audit, queries |
| MD15 Import | 5 to 6 months | Documentation, queries, approval |
Our experience shows that proactive document preparation and swift query responses can reduce delays significantly.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 | Rs 5,000 | Rs 500 |
| MD15 (Class B) | $2,000 (approx Rs 1.6 Lakhs) | $1,000 (approx Rs 80,000) |
Note: Fees are subject to change; always verify on the CDSCO MD Online Portal.
Common Challenges and Solutions
- Delayed Test Reports: Select authorized and reputed testing laboratories early to avoid bottlenecks.
- Incomplete Documentation: Use comprehensive checklists and templates to ensure all documents, such as DMF and PMF, are complete.
- Audit Non-compliance: Prepare your manufacturing site well in advance, including QMS and staff training.
- Query Resolution Delays: Assign dedicated regulatory personnel to monitor and respond to CDSCO communications promptly.
Expert Consultation and Support
Navigating CDSCO licensing for devices like the Barium enema catheter can be complex. Our seasoned regulatory consultants provide end-to-end support—from classification advice and document preparation to audit readiness and post-approval compliance.
Getting Started with Your CDSCO License Application
- Assess your device classification and intended use: Confirm Class B categorization.
- Compile all required technical and legal documents: Leverage our Device Master File and Plant Master File guides.
- Apply for the test license (MD13) immediately if manufacturing: This is the critical first step.
- Engage a notified body early for audit scheduling: Refer to the official Notified Bodies List.
- Submit your application via the CDSCO MD Online Portal and monitor the status regularly.
By following these practical steps, you can minimize surprises and expedite your Barium enema catheter’s entry into the Indian market. For personalized assistance, feel free to contact our regulatory experts.
For further reading and detailed licensing guides, visit our resources on MD5 License, MD9 License, and Import License.
