CDSCO License for Flexible video choledochoscope
Medical Device Information
Intended Use
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD).
Introduction to Flexible Video Choledochoscope and Its Regulatory Importance
The Flexible Video Choledochoscope is a specialized endoscopic device designed for the visual examination and treatment of the common bile duct (CBD). Classified under gastroenterology, this device plays a critical role in minimally invasive procedures, offering clinicians enhanced diagnostic and therapeutic capabilities. Given its direct application in sensitive anatomical regions, regulatory compliance within India is essential for ensuring patient safety, device efficacy, and market access.
At our consultancy, with over 25 years of experience and having assisted 500+ companies, we understand the nuances of navigating the Central Drugs Standard Control Organization (CDSCO) licensing framework for such devices. The notification 29/Misc./03/2020-DC (182), dated 27.09.2021, governs this device’s regulatory pathway in India.
CDSCO Regulatory Framework for Flexible Video Choledochoscope
The CDSCO classifies medical devices into four risk classes: A, B, C, and D, based on their intended use and potential risk to patients. The Flexible Video Choledochoscope falls under Class B due to its invasive nature but relatively lower risk compared to implantable devices.
Being a Class B device, the regulatory pathway requires obtaining an MD5 manufacturing license or an MD15 import license, depending on whether the device is manufactured domestically or imported.
Risk Classification and License Requirements
- Device: Flexible Video Choledochoscope
- Risk Class: B (Low to moderate risk)
- Regulatory Notification: 29/Misc./03/2020-DC (182)
- Licenses Applicable:
- MD5 License (Manufacturing) for domestic producers
- MD15 License (Import) for importers
Class B devices are regulated under the state licensing authority for manufacturing (MD5) and central licensing authority for imports (MD15).
Manufacturing License Process for Class B Devices (MD5 License)
For manufacturers of Flexible Video Choledochoscope, the MD5 license process is mandatory. This license is issued under Form MD3 and regulated by the State Licensing Authority.
Step-by-Step Process:
Test License (Form MD13): Before the full manufacturing license, you must obtain a test license, which allows the device to be tested in government-approved laboratories. This takes approximately 1.5 to 2 months.
Product Testing: Conduct tests on the device in CDSCO-recognized labs to confirm compliance with Indian standards.
Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System records.
Application Submission: Submit the MD5 license application through the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: A physical audit of manufacturing premises is conducted by a notified body listed on the Notified Bodies List for MD5 Audit.
Query Resolution: Address any queries raised by the licensing authority or the notified body.
Grant of License: Upon satisfactory review, the MD5 license is issued in Form MD5.
Total Timeline:
- Approximately 3 to 4 months from test license application to final license grant.
Government Fees:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
Manufacturing License Documents Required for Flexible Video Choledochoscope
To ensure a smooth application process, prepare the following mandatory documents:
- Company Constitution Proof (e.g., Memorandum of Association, Partnership Deed)
- Proof of Premises Ownership or Lease Agreement
- Qualification and Experience Documents of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC (if applicable)
- Device Master File (DMF): Detailed specifications, design, and manufacturing information. Our Device Master File guide provides comprehensive insights.
- Plant Master File (PMF): Details of manufacturing facilities and processes; see our Plant Master File Guide for assistance.
- Essential Principles Compliance Checklist
- Risk Management File documenting identified risks and mitigation strategies. For expert tips, visit our Risk Management guide.
- Test Reports from government-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation aligned with ISO 13485:2016
Import License Process for Flexible Video Choledochoscope (MD15 License)
Importers must obtain the MD15 license for Class B devices, issued by the Central Licensing Authority.
Step-by-Step Process:
Document Preparation: Compile required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and others.
Application Submission: File your application on the CDSCO MD Online Portal using Form MD14.
Review and Query Resolution: CDSCO reviews the documents and may raise queries.
Grant of License: Upon clearance, the MD15 license is issued.
Timeline:
- The entire process typically takes 5 to 6 months.
Fees:
- For Class B devices: Rs 2000 per site and Rs 1000 per product.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Steps | Duration |
|---|---|---|
| MD5 License (Manufacturing) | Test license + Testing + Audit + Application | 3-4 months |
| MD15 License (Import) | Document preparation + Application + Review | 5-6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 License | Rs 5,000 | Rs 500 |
| MD15 License (Class B) | Rs 2,000 | Rs 1,000 |
Additional costs may include audit fees charged by notified bodies and testing laboratory charges, which vary based on device complexity.
Common Challenges and Practical Solutions
Delayed Test Reports: Testing in government-approved labs can experience backlog. Pre-schedule tests and maintain regular communication with labs listed on the Testing Laboratories portal.
Incomplete Documentation: Missing or inconsistent Device or Plant Master Files often cause delays. Use our detailed guides to prepare comprehensive files.
Audit Non-compliance: Non-adherence to QMS or manufacturing standards leads to audit observations. Perform internal audits beforehand to ensure compliance.
Query Management: Slow response to CDSCO queries can prolong timelines. Assign dedicated resources to handle correspondence efficiently.
Expert Consultation and Support
Navigating CDSCO licensing for specialized devices like the Flexible Video Choledochoscope demands meticulous planning and expert know-how. Our seasoned consultants provide:
- Tailored document preparation and review
- Liaison with CDSCO and notified bodies
- Pre-audit readiness assessments
- Risk management and compliance strategy implementation
Our track record of successfully securing over 500 CDSCO licenses positions us as your trusted partner in India's medical device regulatory landscape.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your device’s risk class using the Medical Device Classification tool.
Prepare Essential Documents: Start gathering your Device Master File, Plant Master File, and QMS documentation.
Schedule Product Testing: Identify and book slots in CDSCO-approved testing laboratories.
Apply for Test License: File Form MD13 for the test license through the CDSCO MD Online Portal.
Engage a Notified Body: For manufacturing licenses, select a notified body from the official Notified Bodies List.
Submit Your License Application: Once testing and documents are ready, submit your MD5 (for manufacturing) or MD15 (for import) application.
Taking these concrete steps early optimizes your chances of a timely and successful license grant, enabling you to bring your Flexible Video Choledochoscope to the Indian market efficiently and compliantly.
