CDSCO License for Cholangiography Needle

Comprehensive Guide to CDSCO Licensing for Cholangiography Needle (Class B Medical Device)

Cholangiography needles, classified under disposable hypodermic needles, play a critical role in hepatobiliary diagnostics by allowing precise access to hepatic ducts. With their invasive use, they are regulated as Class B medical devices under the Central Drugs Standard Control Organisation (CDSCO) framework in India. Navigating this regulatory landscape efficiently is vital for manufacturers and importers aiming to launch this device in the Indian market.

With over 25 years of experience and successful support to 500+ companies, we provide an in-depth guide tailored specifically for the Cholangiography Needle, covering essential licensing processes, documentation, timelines, fees, and expert advice.

CDSCO Regulatory Framework for Cholangiography Needle

The CDSCO regulates medical devices in India under the Medical Device Rules (MDR) 2017. Since the Cholangiography Needle is a Class B device, it falls under moderate risk category requiring a manufacturing license (MD5) granted by the State Licensing Authority.

The device is notified under Notification No. 29/Misc/3/2017-DC (292) dated 06.06.2018, confirming its inclusion in the regulatory ambit. Compliance ensures patient safety and market access.

Manufacturers and importers must comply with quality management systems, risk management, and essential principles to secure approval.

Risk Classification and License Requirements for Cholangiography Needle

• Risk Class: B (Moderate risk)
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license

Class B devices require a thorough audit by a notified body and must first obtain a Test License (Form MD13) before the manufacturing license application.

Understanding this classification is crucial to determine the correct application pathway and avoid costly delays. For more on classification, see our Medical Device Classification guide.

Manufacturing License Process (MD5) for Cholangiography Needle

The MD5 license process for Class B devices involves the following sequential steps:

1. Test License Application (Form MD13): Submit an application through the CDSCO MD Online Portal for a test license to manufacture and test the device. This stage takes approximately 1.5-2 months.

2. Product Testing: Get the Cholangiography Needle tested at CDSCO-approved laboratories. Refer to the list of testing laboratories for authorized centers.

3. Document Preparation: Compile technical and quality documents including Device Master File, Plant Master File, and Risk Management File.

4. Manufacturing License Application (Form MD3): Submit the application along with all required documents.

5. Audit by Notified Body: Your manufacturing site will undergo an audit by a notified body. Access the notified bodies list to select an auditor.

6. Query Resolution: Address any queries from the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory compliance, the license is granted.

The entire MD5 license process typically takes 3-4 months from test license application to license issuance.

Manufacturing License Documents Required for Cholangiography Needle

To ensure a successful application, prepare the following documents meticulously:

• Company Constitution documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Technical staff qualifications and experience details
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. Our Device Master File guide provides comprehensive instructions.
• Plant Master File (PMF) describing manufacturing facility and quality systems. Learn more from our Plant Master File guide.
• Essential Principles Checklist confirming compliance with Indian MDR
• Risk Management File documenting hazard analysis and mitigation measures. Visit our Risk Management resource for best practices.
• Test Reports from government-approved labs
• Labeling and Instructions for Use (IFU) samples
• Quality Management System (QMS) documents aligned with ISO 13485:2016

Ensuring completeness and accuracy of these documents helps prevent common delays.

Import License Process (MD15) for Cholangiography Needle

For importers, the MD15 license is mandatory, granted by the Central Licensing Authority. However, since the Cholangiography Needle is Class B, manufacturing license (MD5) is often the primary focus for domestic production.

If importing, the process involves:

• Document preparation including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate if applicable, Device and Plant Master Files, and wholesale license
• Submission of application on Form MD14 via the CDSCO MD Online Portal
• Departmental review and query resolution
• License grant on Form MD15

The import license process takes approximately 5-6 months.

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
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Import license (MD15) processing may take 5-6 months due to central authority involvement.

Government Fees and Costs

For the Cholangiography Needle (Class B device), the fee structure for MD5 license is:

• Application Fee: Rs 5000 per application
• Product Fee: Rs 500 per product

This does not include costs for testing, notified body audit charges, and preparation of technical documentation.

Budgeting for notified body audits is critical; fees vary by agency but typically range from Rs 1-3 lakhs depending on scope.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Submit complete and error-free applications. Follow up regularly via the CDSCO MD Online Portal.

Challenge 2: Incomplete or Improper Documentation

• Solution: Use templates and checklists. Our MD5 License Guide offers detailed insights.

Challenge 3: Audit Non-conformities

• Solution: Conduct internal pre-audit using notified body checklists and ensure QMS compliance.

Challenge 4: Testing Lab Backlogs

• Solution: Book slots early at CDSCO-approved labs found in the Testing Laboratories list.

Expert Consultation and Support

Given the technical and regulatory complexities, partnering with an experienced regulatory consultant can streamline the process, minimize errors, and reduce time-to-market. We leverage our 25+ years of expertise and network of notified bodies and testing labs to facilitate smooth licensing for devices like Cholangiography Needle.

Our services include:

• Tailored gap analysis
• Complete dossier preparation
• Application filing and follow-up
• Audit readiness and support
• Post-approval compliance guidance

Getting Started with Your CDSCO License Application

1. Verify Device Classification: Confirm your device is Class B and requires MD5 license.

2. Prepare Test License Application: Gather preliminary documents and submit Form MD13 via the CDSCO MD Online Portal.

3. Schedule Product Testing: Contact CDSCO-approved labs early to avoid delays.

4. Compile Technical Documentation: Use our Device and Plant Master File guides to prepare robust files.

5. Engage a Notified Body: Select a notified body from the official list for audit planning.

6. Submit Manufacturing License Application (Form MD3): After successful product testing.

7. Prepare for Audit and Queries: Conduct internal reviews and assign resources for prompt responses.

8. Obtain MD5 License and Begin Manufacturing: Maintain compliance with post-market surveillance.

Embarking on this journey with informed preparation and professional support can significantly enhance your chances of timely approval and successful market entry for the Cholangiography Needle in India.