CDSCO License for Flexible video duodenoscope, single-use

Comprehensive Guide to CDSCO Licensing for Flexible Video Duodenoscope (Single-Use, Class B)

Flexible video duodenoscopes are specialized endoscopic devices designed for the visual examination and treatment of the duodenum, the first part of the small intestine. Given their critical role in gastroenterology and the risks associated with invasive procedures, obtaining the correct regulatory approvals in India is paramount. As regulatory consultants with over 25 years of experience and having supported 500+ companies, we provide a detailed walkthrough of the CDSCO licensing process specifically for this single-use, Class B medical device.

Understanding the CDSCO Regulatory Framework for Flexible Video Duodenoscopes

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Flexible video duodenoscopes fall under the gastroenterology category with the notification number 29/Misc./03/2020-DC (182), dated 27.09.2021, classifying this device as Class B risk. This classification is crucial because it determines the regulatory pathway, licensing authority, documentation, testing, fees, and timelines.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk. The CDSCO mandates that manufacturers of Class B devices apply for an MD5 manufacturing license granted by the State Licensing Authority. Importers require an MD15 import license from the Central Licensing Authority.

• Manufacturing License: MD5 (Application Form MD3)
• Import License: MD15 (Application Form MD14)

Manufacturing License Process (MD5) for Flexible Video Duodenoscopes

Obtaining an MD5 license involves multiple steps:

1. Test License (Form MD13): Before manufacturing, obtaining a test license is mandatory. This license allows sample production for testing purposes.
2. Product Testing: Samples must be tested at CDSCO-approved government laboratories. You can find the list of testing laboratories here.
3. Document Preparation: Compile necessary documents including Device Master File, Plant Master File, and Quality Management System (QMS) documents.
4. Application Submission: Submit the manufacturing license application on the CDSCO MD Online Portal using Form MD3.
5. Audit: A notified body will conduct facility and process audits. Refer to the list of notified bodies here.
6. Queries and Clarifications: Address any queries raised by CDSCO or the notified body.
7. License Grant: Upon satisfactory review, the MD5 license will be issued.

Manufacturing License Documents Required

For a single-use flexible video duodenoscope, the following documents are essential:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Fire NOC and Pollution Control NOC
• Qualification and Experience Details of Technical Staff
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File describing manufacturing environment and equipment (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with fundamental safety and performance requirements
• Risk Management File demonstrating risk assessment and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Labels, Instructions for Use (IFU), and Packaging Details
• Quality Management System Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Flexible Video Duodenoscope

For importers intending to bring this device into India, the MD15 license is mandatory. The process entails:

1. Document Compilation: Gather all relevant certificates including manufacturing license, free sale certificate, CE certificate, ISO 13485:2016, and Device/Plant Master Files.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Review and Queries: Address departmental queries promptly.
4. License Issuance: Upon approval, MD15 import license is granted.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale License in India (if applicable)
• Company Constitution and Address Proof

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total

  • Test License (MD13): 1.5-2 months
  • Product Testing: 3-4 weeks
  • Document Preparation & Application Submission: 2-3 weeks
  • Audit & Query Resolution: 4-6 weeks

• MD15 Import License: Approximately 5-6 months

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 Import License:
  • For Class B devices, $2,000 per site +$1,000 per product (approx. Rs 1.5-1.6 lakhs depending on USD conversion)

Note: Fees are subject to change; always verify on the CDSCO MD Online Portal.

Common Challenges and Practical Solutions

• Delayed Test Reports: Testing laboratories often face backlogs. To mitigate, submit samples early and maintain communication with labs.
• Incomplete Documentation: Missing or insufficient documents cause delays. Use comprehensive checklists and expert consultation to ensure completeness.
• Audit Non-Compliance: Facilities may fail audits due to inadequate QMS or poor record-keeping. Regular internal audits and staff training can prevent this.
• Query Resolution Delays: Promptly respond to CDSCO queries with clear, documented evidence to avoid prolonged processing.

Expert Consultation and Support

Leveraging a regulatory partner experienced in CDSCO licensing for Class B gastroenterology devices can streamline your application. Our consultancy has successfully guided 500+ companies through MD5 and MD15 licensing, minimizing delays and maximizing approval success rates. We assist with document drafting, audit preparedness, and liaison with CDSCO and notified bodies.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class B status for your flexible video duodenoscope. Use the Medical Device Classification tool.
2. Prepare Documentation: Start compiling Device and Plant Master Files, QMS documents, and risk management files.
3. Plan Testing Logistics: Identify the nearest CDSCO-approved testing lab and initiate sample testing early.
4. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the application process.
5. Consider a Test License (MD13): Apply for this if manufacturing in India.
6. Engage Experienced Consultants: For tailored guidance, audit support, and document review.

By following these steps and leveraging expert insights, manufacturers and importers of single-use flexible video duodenoscopes can efficiently navigate the CDSCO licensing landscape and successfully enter the Indian market.

For further detailed guidance on the MD5 license process, refer to our MD5 License Guide.

For importers, our Import License Guide provides comprehensive instructions.