CDSCO License for Flexible fibreoptic gastroduodenoscope

Comprehensive Guide to CDSCO Licensing for Flexible Fibreoptic Gastroduodenoscope (Class B Medical Device)

Entering the Indian medical device market with a Flexible Fibreoptic Gastroduodenoscope requires meticulous adherence to CDSCO regulations. This device, classified as a Class B medical device under the gastroenterology category, is critical for visual examination and treatment of the upper gastrointestinal tract. Ensuring compliance with the Central Drugs Standard Control Organization (CDSCO) licensing framework not only guarantees legal market entry but also establishes your product's credibility and safety.

With over 25 years of experience and assisting 500+ companies in securing their CDSCO licenses, we provide you with a detailed, actionable roadmap tailored specifically for your flexible fibreoptic gastroduodenoscope.

CDSCO Regulatory Framework for Flexible Fibreoptic Gastroduodenoscope

The CDSCO regulates all medical devices in India under the Medical Device Rules, 2017. Your device falls under the gastroenterology category and is notified under the Gazette Notification 29/Misc./03/2020-DC (182) dated 27.09.2021. Since it is a Class B device, the manufacturing license needs to be obtained from the State Licensing Authority via the MD5 license pathway, as per the risk classification guidelines.

You can verify your device’s classification and the regulatory requirements on the Medical Device Classification page.

Risk Classification and License Requirements

Device Risk Class: B

Flexible fibreoptic gastroduodenoscopes are Class B devices due to their invasive nature and moderate risk profile. This classification mandates the following:

Manufacturing License: MD5 license (Application Form MD3)
Regulatory Authority: State Licensing Authority
Total Process Duration: Approximately 3-4 months
Fees: Rs 5,000 per application + Rs 500 per product

The MD5 manufacturing license requires a Test License (Form MD13) initially, which facilitates product testing from government-approved labs before the final license application.

Manufacturing License Process (MD5) for Flexible Fibreoptic Gastroduodenoscope

The MD5 license process involves several sequential steps:

Apply for Test License (Form MD13): This initial step allows product testing and takes about 1.5 to 2 months. The test license is essential for sending your gastroduodenoscope samples to government-approved laboratories.
Product Testing: Testing must be done through CDSCO-approved labs. You can find the list of such labs on the Testing Laboratories portal.
Document Preparation: Prepare detailed regulatory documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documents.
Submit Manufacturing License Application (Form MD3) on CDSCO MD Online Portal: Submit your application through the official CDSCO MD Online Portal.
Audit by Notified Body: An audit by a notified body is mandatory. You can select the appropriate auditor from the list of notified bodies.
Resolution of Queries: Address any observations raised by the notified body or CDSCO.
Grant of Manufacturing License (Form MD5): Upon successful audit and query resolution, the license will be granted.

For a detailed walkthrough, refer to our comprehensive MD5 License Guide.

Manufacturing License Documents Required for Flexible Fibreoptic Gastroduodenoscope

The documentation must be thorough and precise. Key documents include:

Company Constitution Proof (Incorporation Certificate, Memorandum & Articles of Association)
Proof of Ownership or Lease Agreement of Manufacturing Premises
Technical Staff Qualification and Experience Records
Fire NOC and Pollution Control NOC
Device Master File (DMF): Detailed device design, specifications, and manufacturing process documentation – see our Device Master File Guide.
Plant Master File (PMF): Documentation about the manufacturing facility – refer to our Plant Master File Guide.
Essential Principles Checklist as mandated by CDSCO
Risk Management File: Comprehensive risk analysis and mitigation strategy in accordance with international standards; learn more about Risk Management.
Test Reports from Government Approved Labs
Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents (ISO 13485:2016 compliance preferred)

Ensuring all documents are complete and accurate helps avoid delays during the audit and application review.

Import License Process (MD15) for Flexible Fibreoptic Gastroduodenoscope

If you plan to import this device into India instead of manufacturing locally, the import license (MD15) must be obtained from the Central Licensing Authority.

Process Highlights:

No test license required.
Submit application on the CDSCO MD Online Portal using Form MD14.
Provide necessary documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.
Address queries during the application review.
License is granted on Form MD15.

The entire import license process typically takes about 5-6 months.

For more information, see our detailed Import License Guide.

Import License Documents Required

Valid Manufacturing License of the device from the country of origin
Free Sale Certificate
ISO 13485:2016 Certificate
CE Certificate (if applicable)
Comprehensive Device Master File
Plant Master File
Wholesale License
Company Constitution documents

Timeline and Processing Duration

License Type	Steps Involved	Duration (Approx.)
MD5 Manufacturing	Test license + testing + audit + queries	3-4 months
MD9 Manufacturing	For Class C/D (not applicable here)	4-5 months
MD15 Import License	Documentation + queries + approval	5-6 months

For your Class B device (MD5 License), expect around 3 to 4 months from test license application to final license grant.

Government Fees and Costs

For the Flexible Fibreoptic Gastroduodenoscope (Class B), the fee structure is:

Test License (MD13): Included in application process
Manufacturing License Application Fee: Rs 5,000 per application
Product Fee: Rs 500 per product (if multiple models or variants, fees apply per product)

These fees are payable via the CDSCO MD Online Portal during the application submission.

Common Challenges and Solutions

Challenge 1: Delays in Test License and Testing

Solution: Submit thorough and error-free test license application; choose notified/testing labs with proven turnaround times.

Challenge 2: Incomplete Documentation

Solution: Utilize checklists and expert review to ensure comprehensive submission of DMF, PMF, Risk Management Files, and QMS documents.

Challenge 3: Audit Non-conformities

Solution: Conduct internal mock audits and remediate potential issues before notified body visits.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to respond promptly with well-documented clarifications.

By proactively addressing these pain points, manufacturers can significantly reduce overall licensing timelines.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex, especially for specialized devices like the flexible fibreoptic gastroduodenoscope. Our team, with 25+ years of expertise and over 500 successful CDSCO license approvals, offers:

Customized regulatory strategy
Complete documentation preparation and review
Liaison with CDSCO and notified bodies
Audit readiness training
Post-approval compliance support

Engaging expert consultants early in your regulatory journey can expedite approvals and mitigate risks.

Getting Started with Your CDSCO License Application

To initiate your licensing process for the flexible fibreoptic gastroduodenoscope:

Register on the CDSCO MD Online Portal.
Prepare your test license application (Form MD13), gathering all preliminary documents and ensuring product samples are ready for testing.
Identify and coordinate with a government-approved testing laboratory.
Begin compiling your Device Master File and Plant Master File concurrently to streamline progress.
Schedule pre-audit consultations with notified bodies to understand expectations.

Starting early, maintaining organized documentation, and leveraging our expert guidance can make your CDSCO licensing journey smooth and successful.

For detailed, step-by-step assistance, feel free to contact us and benefit from our proven track record in medical device regulatory compliance.