CDSCO License for Sclerotherapy Needle/ Catheter

Comprehensive Guide to CDSCO Licensing for Sclerotherapy Needle/ Catheter (Class B)

As experienced regulatory consultants with over 25 years in the medical device sector, we have supported more than 500 companies in successfully obtaining CDSCO licenses. This guide focuses specifically on the regulatory requirements for the Sclerotherapy Needle/ Catheter, categorized as a Class B medical device under Indian regulations. Our goal is to provide you with detailed, actionable insights to navigate the CDSCO licensing process efficiently.

Introduction: Understanding Sclerotherapy Needle/ Catheter and Its Regulatory Importance

The Sclerotherapy Needle/ Catheter is a critical device designed to provide access for injection therapy, polypectomy, and endoscopic procedures. Categorized under Catheters and notified via Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, this device falls under Risk Class B according to the CDSCO medical device classification. Given its clinical importance, obtaining the correct regulatory approval is not just mandatory but essential for ensuring patient safety and market access.

CDSCO Regulatory Framework for Catheters (Sclerotherapy Needle/ Catheter)

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. For Class B devices like the Sclerotherapy Needle/ Catheter, the regulatory framework mandates a Manufacturing License under the MD5 form (Application Form MD3), issued by the State Licensing Authority. Compliance with the Drugs and Cosmetics Act, 1940 and its rules is compulsory.

Manufacturers are required to obtain a Test License (Form MD13) initially, conduct product testing through CDSCO-approved laboratories, and then proceed with the full manufacturing license application.

Risk Classification and License Requirements for Sclerotherapy Needle/ Catheter

According to the CDSCO classification, the Sclerotherapy Needle/ Catheter is Class B (Low Moderate Risk). This classification means:

• License Type: MD5 License (Form MD3)
• Licensing Authority: State Licensing Authority
• Process Duration: Approximately 3 to 4 months
• Test License Required: Yes, Form MD13

For a detailed understanding of device classification, you can refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

The manufacturing license application for the Sclerotherapy Needle/ Catheter follows these steps:

1. Obtain Test License (Form MD13): Submit initial application to get a test license allowing you to manufacture the device for testing purposes. This step typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at government-approved labs. Refer to the Testing Laboratories list for accredited facilities.

3. Documentation Preparation: Prepare the comprehensive registration dossier including Device Master File, Plant Master File, Risk Management File, and other required documents.

4. Application Submission (Form MD3): Apply for the MD5 license via the CDSCO MD Online Portal.

5. Audit by Notified Body: Engage an approved notified body for a mandatory audit of your manufacturing site and QMS. You can check the list of notified bodies before selecting one.

6. Queries and Clarifications: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory completion of audits and document verification, the State Authority grants the manufacturing license.

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

Manufacturing License Documents Required for Sclerotherapy Needle/ Catheter

The dossier for your MD5 license must include:

• Company Constitution and Registration Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File: Detailed design and manufacturing information. Our Device Master File guide can assist you.
• Plant Master File: Facility layout, equipment, and quality management system details. Learn more from our Plant Master File guide.
• Essential Principles Checklist confirming compliance with regulatory standards
• Risk Management File demonstrating hazard analysis and mitigation
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation compliant with ISO 13485:2016

Import License Process (MD15) for Sclerotherapy Needle/ Catheter

If you are an importer looking to bring the Sclerotherapy Needle/ Catheter into India, you must apply for the MD15 import license from the Central Licensing Authority. The process involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate if applicable, Device Master File, Plant Master File, and Wholesale License.
• Application submission using Form MD14 on the CDSCO MD Online Portal.
• Resolution of any raised queries.
• License grant within approximately 5-6 months.

For detailed guidance, consult our Import License Guide.

Import License Documents Required for Class B Catheters

• Valid Manufacturing License from the exporter’s country
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (valid in India)
• Company Constitution and Registration

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Typically included in application costs
• MD5 License Application Fee: Rs 5,000 per application
• Additional Fees: Rs 500 per product
• Notified Body Audit Fees: Vary by body; typically Rs 50,000+ depending on audit scope
• Product Testing Costs: Rs 20,000 to Rs 50,000 depending on test parameters

Common Challenges and Solutions

1. Delay in Product Testing: Testing labs often have backlogs. To avoid this, pre-book slots with labs listed on CDSCO’s Testing Laboratories.

2. Documentation Gaps: Incomplete or inconsistent dossiers cause rejections. Invest time in preparing comprehensive Device and Plant Master Files and perform internal audits before submission.

3. Audit Non-compliance: Ensure your manufacturing facility and QMS meet ISO 13485 standards and notified body requirements. Conduct mock audits for preparedness.

4. Query Resolution Delays: Respond promptly and accurately to all CDSCO queries to avoid prolonged processing.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape for Class B devices like the Sclerotherapy Needle/ Catheter can be complex. Our consultancy offers:

• End-to-end assistance from dossier preparation to audit support
• Training on regulatory compliance and QMS implementation
• Timely updates on regulatory changes
• Liaison services with CDSCO and notified bodies

Our proven track record with 500+ successful CDSCO licenses ensures you gain market access efficiently and compliantly.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class B status for your Sclerotherapy Needle/ Catheter.

2. Prepare Preliminary Documentation: Gather company registration, premises proof, and technical staff details.

3. Apply for Test License (Form MD13): Submit your application on the CDSCO MD Online Portal to commence testing.

4. Engage a Notified Body Early: Choose a notified body from the CDSCO list to schedule your audit.

5. Plan for Testing: Contact approved testing laboratories to understand required tests and timelines.

6. Compile Master Files: Develop thorough Device and Plant Master Files using available guides.

7. Submit MD5 License Application: After successful testing and audit, apply for the manufacturing license.

Starting early and following these practical steps will position your company for timely approval and seamless market entry. Should you need expert assistance, our team is ready to support you every step of the way.