CDSCO License for Continuous Flush  Catheter

Introduction to Continuous Flush Catheters and CDSCO Regulatory Importance

Continuous Flush Catheters, classified as Class B medical devices, play a vital role in controlled and selective infusion therapies. Given their critical function, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory to ensure safety, efficacy, and quality for Indian market entry. With over 25 years of experience helping 500+ companies navigate CDSCO licensing, we offer expert guidance tailored specifically for Continuous Flush Catheters.

CDSCO Regulatory Framework for Continuous Flush Catheters

Continuous Flush Catheters fall under the catheter category notified under the CDSCO Medical Device Rules 2017, notification number 29/Misc/3/2017-DC (292) dated 06.06.2018. These devices are regulated as Class B because of their moderate risk profile. CDSCO mandates a manufacturing license (MD5) granted by the State Licensing Authority for such devices. Importers require an MD15 license issued by the Central Licensing Authority.

Risk Classification and License Requirements for Continuous Flush Catheters

• Risk Class: B (Moderate risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority
• Test License: Required (Form MD13)
• Typical Processing Time: 3 to 4 months including test license, product testing, audit, and final approval

Manufacturers must obtain a test license first to conduct mandatory testing at CDSCO-approved labs, followed by audit and licensing.

Manufacturing License Process for Continuous Flush Catheters (MD5)

1. Apply for Test License (Form MD13): This initial step authorizes limited manufacture for product testing purposes. Processing typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing at government-approved laboratories to comply with standards. A list of such testing laboratories is available on the CDSCO portal.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Technical Staff details, Risk Management File, and Quality Management System (QMS) documents.
4. Apply for MD5 License (Form MD3): Submit application via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will perform an on-site audit of manufacturing facilities and QMS. Refer to the list of notified bodies.
6. Query Resolution: Address any queries or observations raised during audit or by CDSCO authorities.
7. License Grant: Upon successful compliance, CDSCO grants the MD5 license (Form MD5).

For detailed guidance, our MD5 License Guide provides step-by-step instructions.

Manufacturing License Documents Required for Continuous Flush Catheters

• Company Constitution and Registration Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety and Pollution Control Certificates (NOCs)
• Device Master File (DMF): Detailed device specifications and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing premises and quality controls (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File demonstrating risk analysis and mitigation (Risk Management)
• Test Reports from approved laboratories
• Product labels, Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 preferred)

Import License Process for Continuous Flush Catheters (MD15)

If you are an importer of Continuous Flush Catheters, you must obtain an Import License (MD15) from the Central Licensing Authority. The process includes:

1. Document Preparation: Collect manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
2. Application Submission: File application using Form MD14 on the CDSCO MD Online Portal.
3. Query Handling: Address any additional information requests by CDSCO.
4. License Grant: Upon clearance, license MD15 is issued.

Typical processing time for import licenses is 5 to 6 months.

For comprehensive details, refer to our Import License Guide.

Import License Documents Required

• Foreign Manufacturer’s valid Manufacturing License
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Importer registration

Timeline and Processing Duration

The whole process for a Class B device like Continuous Flush Catheter typically spans 3 to 4 months.

Government Fees and Costs

• Test License (MD13): No separate fee but administrative costs may apply.
• MD5 License Application Fees: Rs 5,000 per application plus Rs 500 per product.
• Audit Fees: Paid directly to the notified body and varies by auditor.

Budget approximately Rs 10,000 to Rs 20,000 excluding testing and audit fees.

Common Challenges and Solutions

• Delayed Testing Results: Coordinate early with CDSCO-approved labs to schedule testing and avoid bottlenecks.
• Incomplete Documentation: Utilize checklists and expert consultation to ensure all mandatory documents, especially Device and Plant Master Files, are accurately prepared.
• Audit Non-Compliance: Prepare thoroughly with pre-audit inspections and staff training.
• Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries to maintain process timelines.

Our extensive experience enables us to help manufacturers anticipate and overcome these hurdles efficiently.

Expert Consultation and Support

Navigating the regulatory landscape for Continuous Flush Catheters requires precision and experience. We offer end-to-end consulting services including:

• Regulatory strategy and classification
• Documentation preparation and review
• Coordination with CDSCO and notified bodies
• Audit readiness and gap analysis
• Post-license compliance support

Our track record with over 500 successful CDSCO licenses underscores our commitment to client success.

Getting Started with Your CDSCO License Application for Continuous Flush Catheters

1. Assess Your Device Classification: Confirm Class B status via the Medical Device Classification resource.
2. Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal.
3. Engage with CDSCO-Approved Testing Labs: Plan testing schedules early.
4. Prepare Comprehensive Documentation: Utilize our Device and Plant Master File guides.
5. Select a Notified Body for Audit: Refer to the official list of notified bodies and arrange audits.
6. Submit MD5 License Application: Use Form MD3 on the CDSCO portal.
7. Monitor and Respond: Track application status and promptly address queries.

Embarking on your licensing journey with expert support ensures a smooth and timely market entry for your Continuous Flush Catheters. Contact us today to leverage our expertise and streamline your CDSCO compliance process.