CDSCO License for Cholangiopancreatography catheter, single-use
Medical Device Information
Intended Use
A flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, intended 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 CDSCO Licensing Guide for Cholangiopancreatography Catheter, Single-Use
Navigating the regulatory landscape for medical devices in India requires precise knowledge and strategic planning—especially for specialized gastroenterology devices like the single-use cholangiopancreatography catheter. This flexible catheter, designed for endoscopic cannulation of ductal systems during ERCP procedures, falls under Class B risk category and demands compliance with the Central Drugs Standard Control Organization (CDSCO) regulations.
With over 25 years of regulatory consulting experience and 500+ successful license procurements, we provide you a detailed roadmap to secure your CDSCO license efficiently.
CDSCO Regulatory Framework for Cholangiopancreatography Catheter (Class B Device)
The CDSCO oversees medical device regulation under the Medical Device Rules (MDR) 2017, which classify devices based on risk. Your device, a single-use catheter for ERCP, is classified as Class B due to its moderate risk profile.
For Class B devices, the manufacturing license is governed by the State Licensing Authority through the MD5 license process (Form MD3 application). Importers require an MD15 license from the Central Licensing Authority.
Risk Classification and License Requirements
- Device: Cholangiopancreatography catheter, single-use
- Category: Gastroenterology
- Risk Class: B (moderate risk)
- License Type: MD5 (Manufacturing) for Indian manufacturers
- Regulatory Notification: 29/Misc./03/2020-DC (182), dated 27.09.2021
Understanding your device’s classification helps determine the correct license type and regulatory pathway.
Manufacturing License Process (MD5)
For manufacturers planning to produce this device in India, the MD5 license is mandatory. The process involves several stages:
Test License Application (Form MD13): Obtain a test license allowing limited manufacture for testing. This stage typically takes 1.5 to 2 months.
Product Testing: Conduct product tests at government-approved laboratories. Testing must comply with Indian standards and demonstrate safety, performance, and quality.
Document Preparation: Compile technical documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application Submission: Submit the manufacturing license application on the CDSCO MD Online Portal using Form MD3.
Audit: Undergo audit by a notified body selected from the official list. The audit verifies compliance with Good Manufacturing Practices (GMP) and QMS.
Query Resolution: Address any queries raised during document review or audit promptly.
License Grant: Upon successful review and audit, the MD5 license is granted, authorizing commercial manufacturing.
Manufacturing License Documents Required
Ensuring your documentation is thorough and accurate is crucial. For a Class B device like the cholangiopancreatography catheter, you must prepare:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualifications and Experience Details
- Fire and Pollution NOCs
- Device Master File
- Plant Master File
- Essential Principles Checklist demonstrating compliance with relevant standards
- Risk Management File reflecting hazard analysis and mitigation strategies, per Risk Management guidelines
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System documents (e.g., ISO 13485:2016 certification)
Import License Process (MD15)
If you are an importer of cholangiopancreatography catheters, an MD15 import license from CDSCO's Central Licensing Authority is mandatory. The process includes:
Document Preparation: Gather manufacturing license, free sale certificate, ISO 13485 certification, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: File application on the CDSCO MD Online Portal using Form MD14.
Query Resolution: Respond to any queries raised by CDSCO during application scrutiny.
License Approval: Receive MD15 import license enabling legal import and sale in India.
Unlike manufacturing, no test license is required for import.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate affirming product marketing in the source country
- ISO 13485:2016 certification
- CE Certificate or equivalent international regulatory approval
- Device Master File and Plant Master File
- Wholesale license issued by State Authority
- Company Constitution and relevant business licenses
Timeline and Processing Duration
| License Type | Process Duration | Key Steps |
|---|---|---|
| MD5 License (Manufacturing) | 3-4 months total | Test license (1.5-2 months), Testing, Audit, Queries, License grant |
| MD15 License (Import) | 5-6 months | Document review, Queries, License grant |
Timelines may vary based on document completeness and audit scheduling.
Government Fees and Costs
For your Class B device, the fee structure is as follows:
- MD5 License: Rs 5,000 per application + Rs 500 per product
- MD15 Import License: USD 2,000 per site + USD 1,000 per product
These fees are payable online through the CDSCO portal.
Common Challenges and Solutions
Delayed Testing: Testing at government-approved labs can be time-consuming. To mitigate delays, schedule tests early and select laboratories from the approved testing labs list.
Incomplete Documentation: Missing or inconsistent data often leads to query back-and-forth. Use expert-prepared checklists and cross-verify documents before submission.
Audit Non-Compliance: Non-adherence to GMP identified during audit can stall approval. Engage with a notified body experienced in Class B devices and conduct internal pre-audit assessments.
Regulatory Updates: Stay informed on CDSCO notifications such as 29/Misc./03/2020-DC (182) dated 27.09.2021 which can impact device classification and requirements.
Expert Consultation and Support
Given the complexities involved, partnering with regulatory consultants who understand the nuances of gastroenterology devices is invaluable. Our team has supported over 500 companies in obtaining timely CDSCO licenses, providing end-to-end assistance including documentation, testing coordination, audit facilitation, and post-approval compliance.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your cholangiopancreatography catheter’s Class B status via the Medical Device Classification tool.
Prepare Essential Documents: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS certifications.
Apply for Test License (MD13): Initiate the test license to legally manufacture samples for testing.
Coordinate Product Testing: Engage with CDSCO-approved laboratories early to schedule required tests.
Select a Notified Body: Choose a notified body for the audit from the official notified bodies list.
Submit Application on CDSCO Portal: Use the CDSCO MD Online Portal for all submissions and fee payments.
Prepare for Audit and Queries: Conduct internal reviews and be ready to respond promptly to CDSCO or audit queries.
By following these steps with expert guidance, you can secure your MD5 manufacturing license efficiently and bring your cholangiopancreatography catheters to the Indian market confidently.
For tailored support and detailed checklists, contact our regulatory consulting team today and leverage our 25+ years of experience in CDSCO compliance.
