CDSCO License for Cholangiography Catheter

Comprehensive Guide to CDSCO Licensing for Cholangiography Catheters (Class B Devices)

Navigating the regulatory landscape for medical devices in India can be challenging, especially for specialized products like the Cholangiography Catheter. This device, classified as a Class B medical device under the CDSCO framework, plays a critical role in the diagnostic evaluation of bile ducts during laparoscopic cholecystectomy procedures. With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we provide you with expert, actionable guidance to successfully register and market your Cholangiography Catheter in India.

CDSCO Regulatory Framework for Cholangiography Catheters

Cholangiography Catheters fall under the Catheters category and are regulated as Class B devices by CDSCO, as per the notification 29/Misc/3/2017-DC (292). This classification mandates compliance with specific licensing requirements designed to ensure device safety and efficacy.

The licensing authority for Class B devices is the State Licensing Authority via the MD5 license process. This ensures a streamlined but thorough review, including product testing and audits.

Risk Classification and License Requirements for Cholangiography Catheter

• Classification: Class B (Low to Moderate Risk)
• License Required: Manufacturing License (MD5 License) under Form MD3
• Authority: State Licensing Authority
• Notification Date: 06.06.2018

For detailed classification, please review the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process for Cholangiography Catheters comprises several critical steps:

1. Test License Application (Form MD13): Initially, manufacturers must apply for a test license to conduct product testing. This takes approximately 1.5 to 2 months.

2. Product Testing: Testing must be performed at CDSCO-approved laboratories. The catheter's biocompatibility, sterility, and functionality are typically evaluated. Refer to the Testing Laboratories list for government-approved labs.

3. Documentation Preparation: This involves compiling technical files such as Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and quality management system (QMS) documents.

4. Application Submission: Submit your MD5 application using Form MD3 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A mandatory audit of manufacturing premises and documentation by a notified body listed here follows.

6. Resolution of Queries: Address any queries raised by the State Licensing Authority or notified body promptly.

7. Grant of License: Once all requirements are met, the MD5 Manufacturing License is issued in Form MD5.

For a detailed walkthrough of the MD5 licensing process, see our MD5 License Guide.

Manufacturing License Documents Required for Cholangiography Catheters

To ensure a smooth approval process, prepare the following documents:

• Company Constitution: Incorporation certificate, Memorandum & Articles of Association
• Proof of Ownership of Premises: Sale deed or lease agreement
• Technical Staff Documents: Qualifications and experience certificates
• Fire NOC & Pollution NOC: From local authorities
• Device Master File (DMF): Detailed design, manufacturing process, and specifications. Our comprehensive Device Master File guide can assist in preparation.
• Plant Master File (PMF): Details of the manufacturing facility and quality control systems. Learn more with our Plant Master File guide.
• Essential Principles Checklist: Compliance with Indian medical device standards
• Risk Management File: Risk assessment and mitigation strategies. Refer to our Risk Management resource.
• Test Reports: From CDSCO-recognized laboratories
• Product Labels & Instructions for Use (IFU): As per regulatory requirements
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal SOPs

Import License Process (MD15) for Cholangiography Catheters

If you intend to import Cholangiography Catheters, an MD15 Import License is mandatory, issued by the Central Licensing Authority.

The process generally takes 5 to 6 months and involves:

• Document preparation, including a valid manufacturing license from the country of origin
• Application submission on Form MD14 through the CDSCO MD Online Portal
• Resolution of departmental queries
• Grant of MD15 license

Import license documents include:

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

For detailed guidance, visit our Import License Guide.

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months from test license application to final grant of MD5 license.

Government Fees and Costs

The fee structure for Cholangiography Catheters (Class B) under MD5 licensing includes:

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product

Additional costs to consider:

• Testing laboratory charges (varies by test scope; typically Rs. 50,000 – Rs. 1,00,000)
• Notified body audit fees (range from Rs. 50,000 to Rs. 1,00,000 depending on scope)
• Consultancy or regulatory assistance fees, if outsourced

Common Challenges and Practical Solutions

Challenge 1: Delays in Test License Approval

• Solution: Pre-prepare all test license documents meticulously and submit well in advance to avoid bottlenecks.

Challenge 2: Non-compliance during Audit

• Solution: Conduct internal pre-audits and gap analyses using notified body checklists before the official audit.

Challenge 3: Incomplete Risk Management Documentation

• Solution: Implement a robust risk management process early in development, referencing ISO 14971 standards.

Challenge 4: Inadequate Labeling and IFU

• Solution: Ensure labels and instructions comply with CDSCO guidelines and include bilingual language if required.

Expert Consultation and Support

Partnering with experienced regulatory consultants can significantly streamline your CDSCO licensing journey. With deep insights into the nuances of Class B device registration, we provide:

• End-to-end support from documentation to audit readiness
• Liaison with notified bodies and CDSCO officials
• Customized training on regulatory compliance
• Assistance with post-approval compliance and renewals

Getting Started with Your CDSCO License Application for Cholangiography Catheters

1. Assess Your Product Classification: Confirm Class B status using official CDSCO resources.
2. Prepare Your Test License Application: Gather necessary documents early.
3. Select Accredited Testing Laboratory: Choose from the approved list to conduct product testing.
4. Compile Comprehensive Technical Documentation: Device Master File, Plant Master File, and risk files are critical.
5. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
6. Plan for Audit: Schedule with a notified body listed here.
7. Submit Final MD5 Application: After successful testing and audit.

By following these practical steps and leveraging expert support, your Cholangiography Catheter can successfully enter the Indian market with full regulatory compliance.

For further assistance, consult our detailed MD5 License Guide or contact our regulatory team.

Embark on your CDSCO licensing journey confidently with our proven expertise and comprehensive support tailored specifically for Cholangiography Catheter manufacturers.