CDSCO License for Biliary manometric catheter

Comprehensive Guide to CDSCO Licensing for Biliary Manometric Catheter (Class B Medical Device)

Introduction: Understanding the Biliary Manometric Catheter and Its Regulatory Significance

The biliary manometric catheter is a critical gastroenterology device designed as a sterile, non-electrical flexible tube for insertion into the biliary tree to measure ductal pressures and evaluate sphincter of Oddi function. Given its invasive nature and clinical importance, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures safety, efficacy, and quality compliance before market entry in India.

As regulatory consultants with over 25 years of experience and having supported 500+ medical device companies, we provide you with an in-depth roadmap for obtaining the necessary CDSCO licensing specifically for Class B devices like the biliary manometric catheter.

CDSCO Regulatory Framework for Biliary Manometric Catheters

Under the Indian Medical Device Rules, 2017, the biliary manometric catheter falls under Class B (Low Moderate Risk) as per notification 29/Misc./03/2020-DC (182) dated 27.09.2021. This classification requires manufacturers to obtain the MD5 manufacturing license from the State Licensing Authority before commencing production or import.

The regulatory pathway includes:

• Acquiring a Test License (Form MD13)
• Product testing in government-approved labs
• Submission of a detailed license application (Form MD3)
• Audit by a notified body
• License grant on Form MD5

Risk Classification and License Requirements for Class B Devices

Class B devices like the biliary manometric catheter are considered low to moderate risk. They require State-level licensing under MD5 with mandatory product testing and quality system audits. The total process typically spans 3 to 4 months.

For detailed classification, manufacturers can refer to the comprehensive Medical Device Classification guide.

Manufacturing License Process (MD5) for Biliary Manometric Catheter

The MD5 manufacturing license process involves several essential steps:

1. Test License Application (Form MD13): Apply for a test license to produce samples for testing. This stage takes approximately 1.5 to 2 months.
2. Product Testing: Samples must be tested in CDSCO-approved laboratories to verify compliance with applicable standards. Refer to the Testing Laboratories list for authorized facilities.
3. Document Preparation: Compile all required technical and administrative documents.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: A CDSCO-recognized notified body conducts an on-site audit assessing compliance. Check the list of notified bodies to select the appropriate auditor.
6. Query Resolution: Address any observations or queries raised by the authorities or notified body.
7. License Grant (Form MD5): Upon successful evaluation, the State Licensing Authority grants the manufacturing license.

Manufacturing License Documents Required for MD5

For a Class B biliary manometric catheter, the following documents are mandatory:

• Company Constitution (e.g., Incorporation Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File describing manufacturing infrastructure and quality control (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with regulatory requirements
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Biliary Manometric Catheter

If you plan to import the biliary manometric catheter into India, the MD15 import license from the Central Licensing Authority is required. The process includes:

• Document compilation including manufacturing license from the origin country, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files
• Application submission on Form MD14 through the CDSCO MD Online Portal
• Resolution of departmental queries
• License grant on Form MD15

The import license process generally takes 5 to 6 months. No test license is required for import.

Import License Documents Required

Key documents for the MD15 import license include:

• Valid manufacturing license from country of origin
• Free Sale Certificate ensuring commercial distribution rights
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device and Plant Master Files
• Wholesale license for distribution in India
• Company Constitution documents

Timeline and Processing Duration

For Class B biliary manometric catheter manufacturers, expect the following timelines:

Total: Approximately 3 to 4 months.

For import license (MD15), the overall timeline is 5 to 6 months.

Government Fees and Costs

The fee structure for MD5 manufacturing license for Class B devices is as follows:

• Application Fee: Rs. 5,000
• Per Product Fee: Rs. 500

Additional costs may include:

• Testing fees charged by government-approved laboratories
• Audit fees payable to notified bodies
• Consultancy fees if professional assistance is engaged

It is prudent to budget accordingly, considering all ancillary expenses.

Common Challenges and Solutions

Challenge: Delays in product testing due to laboratory backlogs.

• Solution: Submit samples to multiple approved labs early and maintain communication.

Challenge: Non-compliance observations during the notified body audit.

• Solution: Conduct thorough pre-audit internal reviews and gap analyses.

Challenge: Incomplete documentation leading to query cycles.

• Solution: Use comprehensive checklists and expert consultation for document preparation.

Challenge: Understanding complex regulatory requirements.

• Solution: Engage experienced regulatory consultants to guide through the nuances.

Expert Consultation and Support

Navigating the CDSCO licensing process for biliary manometric catheters can be complex. With over 25 years of expertise, we have successfully guided 500+ manufacturers and importers through this journey. Our services include:

• End-to-end license application management
• Document preparation and review
• Laboratory coordination for testing
• Audit readiness and compliance
• Query resolution support

Partnering with seasoned consultants minimizes risks, expedites approvals, and ensures regulatory compliance.

Getting Started with Your CDSCO License Application

To initiate your licensing process:

1. Evaluate Device Classification: Confirm your device is Class B using the Medical Device Classification resource.
2. Register on the CDSCO MD Online Portal: Begin your application at the CDSCO MD Online Portal.
3. Prepare Documents: Assemble all mandatory documents including Device Master File and Plant Master File.
4. Apply for Test License (MD13): Submit test license application to manufacture samples.
5. Coordinate Product Testing: Send samples to government-approved labs (Testing Laboratories).
6. Arrange Audit: Engage a notified body from the Notified Bodies list for your compliance audit.
7. Submit Manufacturing License Application (MD3): Upload all documents and audit reports.
8. Respond to Queries Promptly: Ensure swift resolution of any regulatory questions.

Starting early and maintaining organized documentation will streamline your path to CDSCO licensing for the biliary manometric catheter. For personalized assistance, contact our expert regulatory team today and leverage our proven track record for a smooth approval process.