CDSCO License for Flexible ultrasound duodenoscope

Understanding Flexible Ultrasound Duodenoscope and Its Regulatory Importance

A Flexible Ultrasound Duodenoscope is a sophisticated medical device combining a flexible endoscope with an ultrasound probe, designed for visual examination and therapeutic interventions within the duodenum. Classified under Interventional Radiology, it offers minimally invasive diagnosis and treatment options for gastrointestinal conditions.

Given its complexity and patient-contact nature, regulatory compliance in India requires obtaining the appropriate CDSCO license. This ensures safety, efficacy, and quality before the device can be marketed or manufactured in India.

CDSCO Regulatory Framework for Flexible Ultrasound Duodenoscope

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. As per the notification 29/Misc./03/2020-DC (146), published on July 26, 2021, the Flexible Ultrasound Duodenoscope is classified as a Class B medical device.

Class B devices are considered low moderate risk and fall under the purview of the State Licensing Authority for manufacturing licenses, while import licenses require approval from the Central Licensing Authority.

Risk Classification and License Requirements for Class B Devices

According to CDSCO’s medical device classification, Class B devices like the Flexible Ultrasound Duodenoscope require an MD5 Manufacturing License for local production and an MD15 Import License for importing into India.

• MD5 License (Form MD3) is granted by the State Licensing Authority.
• MD15 License (Form MD14) is granted by the Central Licensing Authority.

Manufacturing License Process for Flexible Ultrasound Duodenoscope (MD5 License)

For manufacturers aiming to produce Flexible Ultrasound Duodenoscopes domestically, the MD5 license process involves several key steps:

1. Obtain Test License (Form MD13): Initial permission to conduct product testing at government-approved laboratories. This step typically takes 1.5 to 2 months.

2. Product Testing: Sample devices must be tested for compliance with applicable standards at CDSCO-approved labs.

3. Document Preparation: Prepare comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Application Submission: Apply online via the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: An on-site audit conducted by a notified body listed on the Notified Bodies List to verify compliance with quality management systems and manufacturing practices.

6. Resolution of Queries: Address any clarifications or deficiencies raised by CDSCO or the notified body.

7. Grant of MD5 License (Form MD5): Upon successful completion, the license is granted enabling commercial manufacturing.

Timeline

The entire MD5 process typically spans 3 to 4 months, including test license issuance, testing, audit, and final approval.

Manufacturing License Documents Required for Flexible Ultrasound Duodenoscope

To ensure a smooth review process, manufacturers must prepare the following documentation:

• Company Constitution Documents: Incorporation certificate, Memorandum and Articles of Association.
• Proof of Ownership or Lease of Premises: Valid property documents for the manufacturing site.
• Technical Staff Qualifications: Details and qualifications of responsible technical personnel.
• Fire and Pollution NOCs: No Objection Certificates from relevant authorities.
• Device Master File (DMF): Comprehensive details of device design, specifications, and manufacturing process. Our Device Master File guide offers detailed insights.
• Plant Master File (PMF): Information on manufacturing facilities and quality control procedures. Learn to create an effective PMF here.
• Essential Principles Checklist: Compliance with Indian medical device essential principles.
• Risk Management File: Documentation of risk assessment and mitigation processes compliant with ISO 14971. Refer to our Risk Management guide.
• Test Reports: From CDSCO-approved labs confirming product safety and performance.
• Labels and Instructions for Use (IFU): Drafts for review.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal procedures.

Import License Process for Flexible Ultrasound Duodenoscope (MD15 License)

Importers must obtain the MD15 license via the Central Licensing Authority before marketing Flexible Ultrasound Duodenoscopes in India.

Key steps include:

1. Document Preparation: Collate required documents including the manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE certificate, and relevant technical files.

2. Online Application: Submit Form MD14 through the CDSCO MD Online Portal.

3. Review and Queries: Address any technical or administrative queries from CDSCO.

4. License Grant: Upon satisfactory review, the MD15 license is issued.

Import License Documents Required

• Valid Manufacturing License from the country of origin.
• Free Sale Certificate proving product marketability abroad.
• ISO 13485:2016 certification.
• CE Certificate or equivalent regulatory approval.
• Device Master File and Plant Master File.
• Wholesale Drug License (if applicable).
• Company Constitution Documents.

Timeline and Processing Duration

• MD5 License: Approximately 3 to 4 months (including test license and audits).
• MD15 Import License: Approximately 5 to 6 months.

Proactive document preparation and early engagement with notified bodies can significantly reduce delays.

Government Fees and Costs

• MD5 License for Class B Device:

  • Application fee: ₹5,000
  • Per product fee: ₹500

• MD15 Import License Fees for Class B:

  • Site fee: $2,000
  • Per product fee: $1,000

These fees are payable during the application process via the CDSCO portal.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to sample preparation or lab backlogs.

Solution: Engage accredited labs early and prepare samples adhering strictly to testing protocols.

Challenge 2: Incomplete or inconsistent documentation leading to repeated queries.

Solution: Use comprehensive checklists and expert review of technical files before submission.

Challenge 3: Audit non-compliance due to gaps in QMS or manufacturing processes.

Solution: Conduct internal audits and staff training aligned with ISO 13485 standards prior to notified body audits.

Challenge 4: Complex query resolution causing timeline extensions.

Solution: Maintain clear communication with CDSCO officials and seek expert regulatory consultancy support.

Expert Consultation and Support

With over 25 years in medical device regulatory consulting, our team has successfully assisted 500+ manufacturers and importers in navigating CDSCO licensing for Class B devices like the Flexible Ultrasound Duodenoscope.

We offer:

• Tailored gap assessments for your documentation and facilities.
• End-to-end application preparation and submission support.
• Coordination with notified bodies and testing labs.
• Training programs for compliance and audit readiness.

Getting Started with Your CDSCO License Application

Ready to enter the Indian market with your Flexible Ultrasound Duodenoscope? Follow these actionable steps:

1. Classify Your Device Precisely: Confirm Class B status and license type using the CDSCO classification tool.

2. Prepare Test Samples: Coordinate with CDSCO-approved testing labs early. See the Testing Laboratories list.

3. Compile Technical Documentation: Assemble Device Master File, Plant Master File, Risk Management File, and other key documents.

4. Apply for Test License (if manufacturing): Submit Form MD13 on the CDSCO MD Online Portal.

5. Plan for Audit: Select a notified body from the Notified Bodies List and schedule the audit.

6. Submit MD5 or MD15 Application: Upon successful completion of earlier steps, apply online for your manufacturing or import license.

7. Engage Expert Support: Leverage our regulatory consulting services to streamline your pathway and avoid costly pitfalls.

By following these steps with meticulous preparation, you can achieve timely CDSCO approval and successfully launch your Flexible Ultrasound Duodenoscope in India’s growing medical device market.