CDSCO License for Flexible video oesophagoscope, single- use
Medical Device Information
Intended Use
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus.
Understanding Flexible Video Oesophagoscope (Single-Use) and Its Regulatory Importance in India
The Flexible Video Oesophagoscope is a specialized medical device designed for the flexible visual examination and treatment of the oesophagus. Classified under risk Class B, this single-use endoscope plays a pivotal role in gastroenterology diagnostics and interventions. Due to its invasive nature and direct contact with mucosal surfaces, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures patient safety and device efficacy. For manufacturers and importers aiming to introduce this device into the Indian market, securing a CDSCO license is both a legal mandate and a critical quality benchmark.
CDSCO Regulatory Framework for Flexible Video Oesophagoscope (Class B Devices)
As a Class B medical device, the Flexible Video Oesophagoscope falls under the medium-risk category according to CDSCO’s risk classification system. Governed by the Ministry of Health and Family Welfare, CDSCO’s regulatory framework mandates a thorough evaluation encompassing laboratory testing, technical documentation review, and on-site audits before granting manufacturing or import licenses.
The device is notified under reference 29/Misc./03/2020-DC (182) dated 27.09.2021, aligning it with the latest regulatory updates to ensure compliance with Indian medical device rules. Compliance with these regulations not only safeguards end-users but also facilitates smoother market access.
Risk Classification and License Requirements for Single-Use Flexible Video Oesophagoscope
Based on the device’s intended use and risk profile, it is classified as Class B. This classification requires manufacturers to obtain an MD5 license, which is issued by the State Licensing Authority. The MD5 process is designed to ensure that medium-risk devices meet the necessary safety, efficacy, and quality standards before manufacturing and marketing.
Manufacturing License Process: MD5 License (Form MD3)
The pathway to obtaining an MD5 manufacturing license for Class B devices like the Flexible Video Oesophagoscope is detailed and structured, typically spanning 3 to 4 months. Here’s a stepwise overview:
Apply for Test License (Form MD13): Initially, manufacturers must secure a test license to initiate product testing. This step takes approximately 1.5 to 2 months.
Product Testing: Testing must be conducted at CDSCO-approved laboratories. This critical phase verifies that the device meets all prescribed safety and performance standards. You can find a list of CDSCO-approved testing laboratories to select the right facility.
Document Preparation: Concurrently, prepare comprehensive documentation including the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and others. Our detailed Device Master File guide and Plant Master File guide can significantly ease this process.
Application Submission: Submit the MD5 license application using Form MD3 through the CDSCO MD Online Portal. Ensure all required documents are uploaded accurately to avoid delays.
Audit by Notified Body: An on-site audit will be conducted by a notified body from the list of notified bodies. This audit evaluates compliance with Good Manufacturing Practices (GMP) and quality systems.
Queries Resolution: Any queries or observations raised by the licensing authority or notified body must be promptly addressed.
License Grant: Upon successful audit and documentation review, the MD5 license is granted, allowing the device to be manufactured legally in India.
Manufacturing License Documents Required
For the Flexible Video Oesophagoscope (Class B), ensure you have the following documentation ready:
- Company Constitution (e.g., Memorandum of Association, Partnership Deed)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF)
- Plant Master File (PMF)
- Essential Principles Checklist
- Risk Management File (per ISO 14971 standards) — see our Risk Management guide
- Test Reports from CDSCO-approved laboratories
- Device Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process: MD15 License
If your business model involves importing the Flexible Video Oesophagoscope rather than manufacturing it domestically, you must obtain an MD15 import license. This license is issued by the Central Licensing Authority and generally takes 5 to 6 months to process.
The steps include:
- Preparation of all relevant documents such as Manufacturing License from the country of origin, CE Certificate, ISO 13485:2016 certification
- Submission of application on the CDSCO MD Online Portal using Form MD14
- Responding to queries raised during the application review
- License grant on Form MD15, authorizing import and sale in India
The import license requires documentation including:
- Valid Manufacturing License of the device
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
More detailed guidance is available in our Import License guide.
Timeline and Processing Duration for MD5 License
| Process Step | Duration |
|---|---|
| Test License (MD13) Application | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | Concurrent with testing |
| Application Submission | Immediate post-preparation |
| Audit and Review | 4 to 6 weeks |
| Queries and Resolution | 2 to 4 weeks |
| Total Estimated Time | 3 to 4 months |
Government Fees and Costs
For Class B devices like the Flexible Video Oesophagoscope, the fee structure is as follows:
- Application Fee: ₹5,000 per application
- License Fee: ₹500 per product
These fees are payable through the CDSCO MD Online Portal during application submission.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing Many applicants face prolonged delays in receiving test reports due to limited capacity at approved laboratories.
Solution: Plan your testing schedule well in advance and coordinate with multiple accredited labs from the CDSCO Testing Laboratories list to avoid bottlenecks.
Challenge 2: Incomplete or Inaccurate Documentation Incomplete Device Master Files or Plant Master Files often result in application rejections or queries.
Solution: Utilize expert templates and refer to industry best practices outlined in our DMF and PMF guides to ensure completeness and compliance.
Challenge 3: Audit Non-Compliance During notified body audits, failure to demonstrate GMP adherence may lead to audit failure.
Solution: Conduct internal pre-audits and staff training to ensure readiness before the official audit.
Expert Consultation and Support
With over 25 years of industry experience and having successfully guided 500+ companies through the CDSCO licensing landscape, we offer end-to-end regulatory consultancy tailored to the Flexible Video Oesophagoscope and similar Class B devices. Our services include:
- Comprehensive gap analysis and document preparation
- Coordination with notified bodies and testing labs
- Timely application submission and follow-up
- Training for audit preparedness
Partnering with seasoned experts can significantly reduce time to market and ensure regulatory compliance.
Getting Started with Your CDSCO License Application for Flexible Video Oesophagoscope
Ready to enter the Indian market? Here’s a practical roadmap to initiate your CDSCO licensing process:
Determine Your Pathway: Decide between manufacturing locally (MD5 license) or importing (MD15 license).
Register on CDSCO MD Online Portal: Create an account and familiarize yourself with the submission process at the official portal.
Compile Required Documents: Start assembling your Company Constitution, DMF, PMF, and other mandatory documents.
Apply for Test License (if manufacturing): Submit Form MD13 to begin product testing.
Schedule Testing: Engage with CDSCO-approved laboratories early to avoid delays.
Prepare for Audit: Select a notified body and conduct internal audits to ensure compliance.
Submit Manufacturing License Application: Once testing and audits are complete, file Form MD3 for MD5 license.
Respond Promptly to Queries: Monitor application status regularly and address any questions from CDSCO or auditors.
By following these actionable steps and leveraging our expert consultancy, you can navigate the CDSCO licensing process for your Flexible Video Oesophagoscope efficiently and effectively.
For personalized assistance, feel free to contact us to discuss your project requirements and receive tailored regulatory support.
Note: The timelines and fees mentioned are subject to updates by CDSCO; always verify with the latest official notifications before proceeding.
