CDSCO License for Flexible video choledochoscope, single- use

Comprehensive Guide to CDSCO Licensing for Flexible Video Choledochoscope (Single-Use) Class B Devices

Navigating the Indian regulatory landscape for medical devices can be intricate, especially for specialized instruments like the flexible video choledochoscope designed for gastroenterology applications. As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ companies, we provide you with an end-to-end insight into the CDSCO licensing process specifically for your Class B flexible video choledochoscope.

Understanding Your Device and Its Regulatory Significance

The flexible video choledochoscope is a sophisticated, single-use endoscope with a flexible inserted portion, intended for visual examination and treatment of the biliary tract and related ducts such as the common bile duct (CBD), cystic duct, and pancreatic duct. Additionally, it facilitates the removal of gallstones. Due to its invasive nature and critical clinical use, the device is classified as Class B under CDSCO guidelines.

This classification mandates stringent compliance with India’s regulatory framework to ensure safety, efficacy, and quality before market introduction. The governing notification for this device is 29/Misc./03/2020-DC (182), dated 27.09.2021.

CDSCO Regulatory Framework for Flexible Video Choledochoscope

In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO). For Class B devices, the manufacturing license falls under the purview of State Licensing Authorities through the MD5 license process. The process ensures conformity with Indian medical device rules and includes product testing, documentation review, and facility audit.

Risk Classification and License Requirements

Flexible video choledochoscopes are designated as Class B due to their moderate risk profile. This classification implies:

• License Type: MD5 (Manufacturing License for Class A and B devices)
• Regulatory Authority: State Licensing Authority
• Application Form: MD3 for license application

Class B devices require a rigorous process including a test license, product testing at government-approved laboratories, and audit by a notified body.

For a detailed understanding of device classification and risk management, please refer to our Medical Device Classification and Risk Management guides.

Manufacturing License Process (MD5) for Flexible Video Choledochoscope

The MD5 license process consists of several sequential steps:

1. Test License (Form MD13): Initially, the manufacturer must obtain a test license. This is essential for legally manufacturing the device sample for testing purposes. The test license approval typically takes around 1.5 to 2 months. Learn more through our Test License Guide.

2. Product Testing: Samples manufactured under the test license must be tested at CDSCO-approved laboratories. Testing parameters include biocompatibility, electrical safety, sterility (for single-use devices), and performance as per applicable Indian and international standards. A list of approved testing laboratories is available on the CDSCO Testing Laboratories page.

3. Documentation Preparation: Prepare comprehensive documentation including the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, Quality Management System (QMS) documents, and product labeling including Instructions for Use (IFU).

4. License Application (Form MD3): Submit the manufacturing license application on the CDSCO MD Online Portal attaching all requisite documents.

5. Audit by Notified Body: A notified body approved by CDSCO conducts an on-site audit of your manufacturing facility to verify compliance. Find the list of approved bodies here.

6. Query Resolution: Address any observations or queries raised by the notified body or CDSCO.

7. Grant of License (Form MD5): Upon successful audit and document verification, the State Licensing Authority grants the manufacturing license.

Manufacturing License Documents Required

For your flexible video choledochoscope, the following documents are essential:

• Company constitution documents (e.g., incorporation certificate)
• Proof of ownership or lease of manufacturing premises
• Details of technical staff and their qualifications
• Fire safety and pollution control clearances
• Device Master File (DMF): Detailed design and manufacturing process documentation. Our Device Master File guide provides practical tips.
• Plant Master File (PMF): Facility details and quality systems. Refer to our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with Indian medical device rules
• Risk Management File highlighting risk assessment and mitigation
• Test reports from CDSCO-approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15)

If you are an importer of the flexible video choledochoscope, you must apply for the MD15 import license from the Central Licensing Authority. The process involves:

• Preparation of comprehensive documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), DMF, PMF, and wholesale license.
• Submission of Form MD14 application on the CDSCO MD Online Portal.
• Query resolution and final grant of the MD15 import license within approximately 5-6 months.

For detailed guidance, consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License in India
• Company constitution documents

Timeline and Processing Duration

The entire MD5 manufacturing license process, starting from test license application to license grant, generally spans 3 to 4 months. This timeline can vary depending on audit schedules and query response times.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application fee: Rs. 5000 per application
  • Product fee: Rs. 500 per product

• Test License (MD13): No separate fee beyond application processing

• Import License (MD15): Fees vary by device class and number of products; for Class B devices, expect approximately Rs. 2000 per site and Rs. 1000 per product.

Budgeting for testing, documentation, and notified body audits is also essential. Test fees vary by laboratory and test scope.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to sample non-compliance or incomplete documentation.

Solution: Engage accredited laboratories early, ensure samples strictly meet specifications, and submit complete test protocols.

Challenge 2: Audit non-conformities related to facility compliance and QMS.

Solution: Maintain robust quality management aligned with ISO 13485 and prepare thoroughly for audits using checklists.

Challenge 3: Difficulty in compiling comprehensive Device and Plant Master Files.

Solution: Utilize expert consultancy and templates, such as those in our Device Master File guide and Plant Master File guide.

Expert Consultation and Support

With over two decades of regulatory expertise, we guide manufacturers and importers through every stage—from documentation to audit readiness. Our personalized support has enabled over 500 companies to successfully obtain CDSCO licenses for Class B gastroenterology devices like flexible video choledochoscopes.

Getting Started with Your CDSCO License Application

1. Assess Your Readiness: Review your manufacturing setup and QMS against CDSCO requirements.
2. Engage a CDSCO-Approved Testing Laboratory: Early engagement helps align product specifications with test protocols.
3. Prepare Your Documentation: Utilize expert templates to compile DMF, PMF, Risk Management, and Essential Principles checklists.
4. Apply for Test License (Form MD13): Submit your application via the CDSCO MD Online Portal.
5. Plan for Audit: Identify and schedule audits with notified bodies listed on the CDSCO Notified Bodies portal.
6. Maintain Communication: Promptly address queries from CDSCO or auditors to expedite approval.

Embarking on your CDSCO licensing journey for your flexible video choledochoscope with a clear roadmap minimizes regulatory risks and accelerates market entry. Contact us today to leverage our proven expertise and streamline your pathway to compliance.