CDSCO License for Flexible fibreoptic duodenoscope
Medical Device Information
Intended Use
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine).
Comprehensive Guide to CDSCO Licensing for Flexible Fibreoptic Duodenoscopes (Class B)
As seasoned regulatory consultants with over 25 years of experience and having successfully supported 500+ companies, we understand the nuances of obtaining CDSCO licenses for specialized medical devices like the Flexible Fibreoptic Duodenoscope. This device, classified as Class B under the CDSCO risk classification, plays a critical role in gastroenterology for visual examination and treatment of the duodenum.
Understanding the Device and Regulatory Importance
The flexible fibreoptic duodenoscope is an advanced endoscopic instrument designed for minimally invasive procedures in the first part of the small intestine. Given its direct contact with mucous membranes and invasive use, regulatory compliance ensures patient safety and device efficacy. The Indian government, through CDSCO, mandates strict licensing to control quality and post-market surveillance of such devices.
CDSCO Regulatory Framework for Flexible Fibreoptic Duodenoscopes (Class B)
Under the Medical Device Rules, 2017, flexible fibreoptic duodenoscopes fall under Class B – low to moderate risk devices. This classification dictates the regulatory pathway, which involves the State Licensing Authority issuing the manufacturing license known as the MD5 license (Application Form MD3).
This device is notified under Notification Number 29/Misc./03/2020-DC (182), dated 27.09.2021, confirming its inclusion in CDSCO’s medical device registry.
Risk Classification and License Requirements
- Device Risk Class: B (Low moderate risk)
- License Type: MD5 Manufacturing License (State Authority)
- Import License: MD15 License (Central Authority) if importing
- Test License: MD13 (mandatory preliminary step)
For detailed classification criteria, manufacturers can consult the Medical Device Classification guide.
Manufacturing License Process (MD5) for Flexible Fibreoptic Duodenoscopes
Test License Application (Form MD13): Obtain a test license from the State Licensing Authority to legally manufacture the device for testing purposes. This process typically takes 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved laboratories to validate safety and performance. Refer to the Testing Laboratories list for authorized centers.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a CDSCO-designated notified body is mandatory. Check the Notified Bodies List to select an approved auditor.
Query Resolution: Respond promptly to any queries from the licensing authority or notified body to avoid delays.
Grant of MD5 License: Upon successful audit and document verification, the license will be issued on Form MD5.
This entire process generally takes 3 to 4 months from start to finish.
For an in-depth overview, our MD5 License Guide is a valuable resource.
Manufacturing License Documents Required
- Company Constitution (e.g., MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Credentials of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) – detailing device design and specifications (Guide here)
- Plant Master File (PMF) – manufacturing environment and processes (Guide here)
- Essential Principles Compliance Checklist
- Risk Management File specific to the duodenoscope (Risk Management Guide)
- Test Reports from Government-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 preferred)
Import License Process (MD15) for Flexible Fibreoptic Duodenoscopes
If you are importing the flexible fibreoptic duodenoscope into India, the import license is issued by the Central Licensing Authority via the MD15 license.
Key steps:
- Document Preparation (No test license required for import)
- Application Submission on the CDSCO MD Online Portal using Form MD14
- Queries Resolution
- Grant of MD15 License
Typical timeline is 5 to 6 months.
Required documents include:
- Valid Manufacturing License (MD5 or equivalent)
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
For detailed import guidance, visit our Import License Guide.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| Application Submission | Immediate upon docs |
| Notified Body Audit | 1 month |
| Query Resolution | 2 – 4 weeks |
| Total (MD5 License) | 3 – 4 months |
For imports, expect around 5 to 6 months.
Government Fees and Costs
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product (flexible fibreoptic duodenoscope counts as one product)
Additional costs:
- Notified body audit fees (varies by body and scope)
- Testing fees at government-approved labs (typically ₹50,000 to ₹1,00,000 depending on tests)
Common Challenges and Solutions
- Delay in Test Reports: Government labs may have backlogs; consider scheduling tests early and maintain constant communication.
- Incomplete Documentation: Missing or inconsistent Device or Plant Master Files cause rejections. Use expert templates and checklists.
- Audit Non-Compliance: Prepare thoroughly for notified body audits by conducting internal pre-audit assessments.
- Query Management: Assign dedicated personnel to respond promptly and clearly to CDSCO queries to avoid process delays.
Expert Consultation and Support
Navigating CDSCO's regulatory ecosystem can be complex. Our extensive experience with over 500 successful medical device licenses equips us to:
- Tailor documentation specifically for flexible fibreoptic duodenoscopes
- Coordinate laboratory testing and audit scheduling
- Provide mock audits and compliance training
- Streamline application submissions through the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
Assess your device classification and intended use clearly to confirm Class B status.
Compile initial documents including corporate and manufacturing site proof.
Apply for the Test License (MD13) on the CDSCO portal to start legal manufacturing for testing.
Coordinate with a CDSCO-approved testing laboratory to schedule necessary device tests.
Prepare comprehensive Device Master File and Risk Management File with expert help to ensure compliance.
Select a notified body for your audit and schedule the audit well in advance.
Submit your MD5 license application (Form MD3) via the CDSCO MD Online Portal post testing and audit.
By following these actionable steps and leveraging our expertise, manufacturers and importers can efficiently obtain CDSCO licensing for the flexible fibreoptic duodenoscope, paving the way for successful entry into the Indian healthcare market.
