CDSCO License for Flexible video oesophagoscope, reusable
Medical Device Information
Intended Use
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.
Comprehensive CDSCO Licensing Guide for Flexible Video Oesophagoscope (Reusable) - Class B Medical Device
At our consultancy, with over 25 years of experience and having supported 500+ companies, we understand the nuances of navigating the CDSCO regulatory landscape for medical devices like the reusable flexible video oesophagoscope. This critical gastroenterology instrument requires meticulous adherence to Indian regulatory requirements to ensure timely market entry.
Understanding the Flexible Video Oesophagoscope and Regulatory Importance
A flexible video oesophagoscope is a reusable endoscopic device designed for the visual examination and treatment of the oesophagus. It features a flexible insertion tube and a distal camera that transmits real-time anatomical images to a monitor. Given its invasive use and direct contact with mucosal tissues, the device is classified under Risk Class B by CDSCO, requiring a manufacturing license under the MD5 category.
Regulatory compliance ensures patient safety, device efficacy, and facilitates smooth commercialization. Non-compliance can lead to costly delays, product recalls, or bans.
CDSCO Regulatory Framework for Flexible Video Oesophagoscope (Class B Device)
The Central Drugs Standard Control Organisation (CDSCO) governs medical devices in India, under the Ministry of Health and Family Welfare. As per the Medical Device Rules, 2017, flexible video oesophagoscopes fall under Class B, mandating a State Licensing Authority-issued MD5 manufacturing license.
This license confirms that the manufacturer complies with quality, safety, and performance standards as per the Essential Principles checklist and risk management norms.
Risk Classification and License Requirements
- Device Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (Form MD3 application)
- Regulatory Authority: State Licensing Authority
- Applicable Notifications: 29/Misc./03/2020-DC (182), dated 27.09.2021
Manufacturing License Process for MD5 (Flexible Video Oesophagoscope)
The MD5 license process is multi-step, typically spanning 3-4 months, including:
- Test License (Form MD13): Mandatory initial test license application, valid for 1.5-2 months.
- Product Testing: Samples tested at CDSCO-approved labs to validate compliance. Refer to the list of testing laboratories.
- Document Preparation: Comprehensive technical files, including Device Master File and Plant Master File, are compiled.
- Application Submission: Submit Form MD3 via the CDSCO MD Online Portal along with fees.
- Audit by Notified Body: An audit is conducted to verify manufacturing practices. Check the notified bodies list for authorized auditors.
- Query Resolution: Address any observations or queries raised by the CDSCO or notified body.
- License Grant: Upon satisfactory compliance, the MD5 license (Form MD5) is granted.
Manufacturing License Documents Required
For this Class B gastroenterology device, ensure you prepare the following:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, design, and manufacturing process. Our Device Master File guide offers step-by-step assistance.
- Plant Master File (PMF): Details of the manufacturing facility and quality systems. Refer to our Plant Master File guide.
- Essential Principles Checklist compliance document
- Risk Management File compliant with ISO 14971 (Risk Management guidance)
- Test Reports from CDSCO-approved labs
- Device labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Import License Process (Not Applicable for Manufacturing)
Since the device is intended for domestic manufacturing, import licensing (MD15) is not applicable here. However, for importers, MD15 license from CDSCO Central Licensing Authority is mandatory. More on import licenses can be found in our Import License Guide.
Timeline and Processing Duration
- Test License Application: 1.5 to 2 months
- Product Testing: Concurrently 1-2 months depending on lab workload
- Audit and License Application: 1-1.5 months
- Total Estimated Time: 3 to 4 months from start to finish
Proactively addressing audit findings and submitting complete documentation can help avoid delays.
Government Fees and Costs
- Test License Fee: Included in application
- MD5 License Fee: INR 5,000 per application
- Product Fee: INR 500 per product (Flexible video oesophagoscope counts as one product)
- Audit Charges: Payable to the notified body (varies; typically INR 50,000 to 1,00,000)
Budget approximately INR 1,00,000 to 1,50,000 inclusive of testing, audit, and application fees for this device.
Common Challenges and Solutions
- Incomplete Documentation: Missing Device Master File or risk management details often cause rejections. We recommend thorough pre-submission audits.
- Delayed Testing: Labs may have backlogs; early sample submission can mitigate this.
- Audit Non-Compliance: Manufacturers sometimes miss establishing QMS fully. Partner with notified bodies early to understand expectations.
- Query Resolution Delays: Prompt, clear responses to CDSCO queries expedite processing.
Our consultancy has successfully navigated these hurdles for numerous clients by providing tailored support and checklists.
Expert Consultation and Support
Navigating CDSCO requirements for a reusable flexible video oesophagoscope can be intricate. Our team offers end-to-end support, including:
- Gap analysis of existing documentation
- Assistance in preparing Device and Plant Master Files
- Coordinating product testing and audit scheduling
- Liaison with CDSCO and notified bodies
- Post-license compliance and renewal support
Getting Started with Your CDSCO License Application
- Assess Your Readiness: Ensure you have a manufacturing site and qualified technical staff.
- Document Compilation: Begin assembling your DMF, PMF, and QMS documents.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to start product testing.
- Plan Testing and Audit: Coordinate sample submission with CDSCO-approved labs and schedule notified body audit.
- Prepare for Application: Once testing is complete and audit planned, compile the final application (Form MD3) for the MD5 license.
- Submit and Track: Use the online portal to submit and track your application; respond promptly to any queries.
By following this structured approach, manufacturers can secure their MD5 license efficiently and begin commercializing their flexible video oesophagoscope in India.
For personalized assistance or to discuss your project, feel free to contact our regulatory experts who have a proven track record in CDSCO licensing for medical devices.
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