CDSCO License for Flexible ultrasound gastroduodenoscope

Comprehensive Guide to CDSCO Licensing for Flexible Ultrasound Gastroduodenoscope (Class B)

Flexible ultrasound gastroduodenoscopes are sophisticated gastroenterology devices combining flexible endoscopy with ultrasound imaging, enabling detailed visualization and treatment of the upper gastrointestinal tract including the oesophagus, stomach, duodenum, pancreas, and bile duct. Given their intricate design and clinical importance, strict regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures safety, efficacy, and quality before market entry in India.

With over 25 years of regulatory experience and having assisted more than 500 medical device companies, we provide an expert roadmap to secure the mandatory CDSCO license for your Class B flexible ultrasound gastroduodenoscope.

CDSCO Regulatory Framework for Flexible Ultrasound Gastroduodenoscope

The CDSCO regulates medical devices under the Medical Device Rules, 2017, incorporating risk-based classification and licensing requirements. Your device is notified under Notification No. 29/Misc./03/2020-DC (182), dated 27.09.2021, specifically categorized within gastroenterology devices.

Flexible ultrasound gastroduodenoscopes fall under Class B — low-moderate risk devices — requiring a manufacturing license from the State Licensing Authority via the MD5 licensing route.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B (Low to moderate risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Authority: State Licensing Authority (where manufacturing site is located)
• Process Duration: Approximately 3-4 months
• Associated Fees: Rs 5,000 application fee + Rs 500 per product

For more on device classification, visit our detailed Medical Device Classification guide.

Manufacturing License Process for Flexible Ultrasound Gastroduodenoscope (MD5)

1. Test License (Form MD13): Initially, apply for a test license to manufacture the device for testing purposes. This typically takes 1.5-2 months.
2. Product Testing: Submit samples to CDSCO-approved government testing laboratories to obtain mandatory test reports validating compliance with Indian standards. Refer to the List of Testing Laboratories for authorized facilities.
3. Document Compilation: Prepare comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) documents, Risk Management File, and Essential Principles Checklist.
4. Application Submission: File your manufacturing license application using Form MD3 through the CDSCO MD Online Portal.
5. Audit by Notified Body: Upon acceptance of your application, a notified body conducts a thorough audit of your manufacturing site and QMS. Access the List of Notified Bodies to select an appropriate auditor.
6. Query Resolution: Address any queries or observations raised by CDSCO or the notified body promptly.
7. Grant of License: Once all criteria are met, CDSCO issues the MD5 license (Form MD5), authorizing commercial manufacture.

Our detailed MD5 License Guide offers step-by-step assistance.

Manufacturing License Documents Required

For a Class B device such as the flexible ultrasound gastroduodenoscope, these documents are critical:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical and managerial staff
• Fire and Pollution NOCs from local authorities
• Device Master File (DMF) detailing design, components, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File including hazard analysis and mitigation strategies (Risk Management Overview)
• Test Reports from CDSCO-approved laboratories
• Labels, packaging artwork, and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification and internal procedures)

Import License Process for Flexible Ultrasound Gastroduodenoscope (MD15)

If you are an importer rather than a manufacturer, you must obtain an Import License under Form MD14 leading to a license issuance on Form MD15.

• Authority: Central Licensing Authority (CDSCO HQ)
• Timeline: 5-6 months
• Fees: Varies by device class; Class B fees typically Rs 2000/site + Rs 1000/product
• Key Documents: Manufacturing license of foreign manufacturer, Free Sale Certificate from country of origin, ISO 13485:2016 certificate, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution

Visit our Import License Guide for comprehensive details.

Timeline and Processing Duration

Government Fees and Costs

• MD5 Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product (flexible ultrasound gastroduodenoscope counts as one product)
• Test License Fee: Rs 5,000 (approx.)
• Audit Charges: Paid directly to notified body, typically Rs 50,000 - Rs 1,00,000 depending on audit scope
• Testing Fees: Varies by lab and tests, approx Rs 20,000 - Rs 50,000

Budget realistically for Rs 1,00,000 - Rs 1,50,000 inclusive of all steps to avoid surprises.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants underestimate the depth required in Device and Plant Master Files. Engage experts early to prepare comprehensive, audit-ready documents.
• Delays in Testing: Coordinate sample submission promptly with CDSCO-approved labs and follow up regularly.
• Audit Non-compliance: Pre-audit internal checks can prevent common deficiencies in QMS and premises.
• Query Handling: Assign a dedicated regulatory liaison to ensure swift and accurate responses to CDSCO queries.

Real-world Example: One client’s flexible endoscope manufacturing license was delayed due to inadequate Risk Management documentation. We guided them through a robust risk assessment aligned with ISO 14971, expediting approval.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like flexible ultrasound gastroduodenoscopes. Our team of regulatory consultants offers:

• Gap analysis of your current compliance status
• End-to-end document preparation support
• Coordination with notified bodies and testing labs
• Audit readiness training and mock audits
• Query resolution and liaison with CDSCO officials

Partnering with experienced consultants reduces time-to-market and mitigates regulatory risks.

Getting Started with Your CDSCO License Application

1. Evaluate your device classification carefully to confirm Class B status.
2. Register on the CDSCO MD Online Portal to access application forms.
3. Initiate test license application (Form MD13) and prepare samples for testing.
4. Compile your Device Master File and Plant Master File with attention to detail.
5. Engage a notified body early to schedule audits post testing.
6. Prepare your Quality Management System and Risk Management files to meet audit expectations.
7. Submit your Form MD3 application for MD5 license once test license and test reports are in hand.

By following these actionable steps and leveraging expert guidance, manufacturers can efficiently navigate the CDSCO licensing process for flexible ultrasound gastroduodenoscopes and successfully access the Indian market.

For further assistance, consult our MD5 licensing experts or explore our resource-rich guides linked throughout this article.