CDSCO License for Imaging Catheter

Comprehensive Guide to CDSCO Licensing for Imaging Catheters (Class C)

Imaging catheters are critical medical devices designed for use with various medical imaging consoles, playing a pivotal role in diagnostics and interventional procedures. Given their complexity and clinical significance, they fall under Class C risk category as per CDSCO regulations, necessitating stringent regulatory scrutiny before entering the Indian market.

At our consultancy, with over 25 years of expertise and having supported 500+ companies, we understand the nuances involved in securing your CDSCO license for imaging catheters efficiently and compliantly. This guide provides you with an actionable roadmap covering the regulatory framework, licensing process, documentation, costs, timelines, and practical insights tailored specifically for Class C devices like imaging catheters.

CDSCO Regulatory Framework for Imaging Catheters

The Central Drugs Standard Control Organization (CDSCO) governs medical device imports and manufacturing in India under the Medical Device Rules (MDR) 2017. Imaging catheters, notified under Notification No. 29/Misc/3/2017-DC (292) dated 06.06.2018, are classified as Class C devices due to their invasive nature and potential for moderate to high risk to patients.

Compliance with CDSCO ensures your device meets safety, quality, and performance standards, protecting patients and building trust with healthcare providers.

Risk Classification and License Requirements for Imaging Catheters

According to the Medical Device Rules, Class C devices require a manufacturing license under Form MD7 (MD9 license) issued by the Central Licensing Authority. This is a more rigorous process compared to Class A and B devices, involving product testing, detailed documentation, and an audit by CDSCO inspectors.

For importers, the Import License (MD15) is mandatory and also issued by the Central Authority.

Manufacturing License Process for Imaging Catheters (MD9 License)

The manufacturing license for Class C devices like imaging catheters involves multiple steps:

1. Test License Application (Form MD13): Obtain a test license to produce limited quantities for testing. This step takes approximately 1.5 to 2 months.
2. Product Testing: Samples must be tested at CDSCO-approved government laboratories to verify compliance with quality and safety standards. You can find the list of approved testing laboratories here.
3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. License Application (Form MD7): Submit the manufacturing license application for Class C devices via the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct a thorough audit of your manufacturing facility and quality systems.
6. Queries Resolution: Address any observations or queries raised by the CDSCO or auditors.
7. License Grant: On satisfactory compliance, the MD9 license is granted.

Manufacturing License Documents Required

To ensure a smooth application, gather the following mandatory documents:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing process, and specifications (Refer to our detailed Device Master File guide)
• Plant Master File (PMF) showing manufacturing environment and controls (Plant Master File guide)
• Essential Principles Checklist ensuring compliance with safety and performance requirements
• Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management insights)
• Test Reports from approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 certification is highly recommended)

Import License Process for Imaging Catheters (MD15 License)

If you intend to import imaging catheters into India, the Import License under Form MD14 (granting MD15 license) is mandatory. The process includes:

1. Document Preparation: Assemble required documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
2. Application Submission: File your application through the CDSCO MD Online Portal.
3. Queries Resolution: Respond promptly to any CDSCO queries.
4. License Issuance: Upon compliance, the MD15 import license is granted.

Import License Documents Required

Documents required for MD15 application include:

• Manufacturing License of the device from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution

Timeline and Processing Duration

• MD9 Manufacturing License: Approximately 4 to 5 months from test license application to final license grant. The initial test license takes about 1.5 to 2 months, followed by product testing, document submission, audit, and query resolution.
• MD15 Import License: Usually takes 5 to 6 months due to thorough document verification and regulatory review.

Planning your submission with these timelines in mind helps avoid costly delays.

Government Fees and Costs

• MD9 License: Application fee of Rs. 50,000 plus Rs. 1,000 per product.
• Test License (MD13): Nominal fee applicable.
• MD15 Import License: Fees vary by device class; for Class C devices like imaging catheters, the fee is approximately $3,000 per site plus$1,500 per product.

Budgeting accurately for these fees is essential for cash flow management.

Common Challenges and Practical Solutions

Challenge: Delays in audit scheduling and query responses.

Solution: Prepare pre-audit mock inspections with experienced consultants, ensure all documentation is organized, and maintain transparent communication with CDSCO.

Challenge: Ambiguity in device classification.

Solution: Refer to the Medical Device Classification guide or consult experts to confirm risk class early in your project.

Challenge: Incomplete or inconsistent documentation.

Solution: Develop a checklist based on CDSCO requirements; leverage templates from Device Master File guide and Plant Master File guide to ensure completeness.

Expert Consultation and Support

Navigating the CDSCO licensing maze for Class C devices like imaging catheters can be complex. Our seasoned regulatory consultants offer end-to-end support:

• Pre-submission classification and regulatory strategy
• Preparation and review of Device Master File, Plant Master File, and Risk Management documentation
• Coordination with CDSCO officials and notified bodies
• Assistance in audit preparation and query handling
• Post-approval compliance and vigilance planning

Our proven track record with 500+ successful licenses ensures your submissions are robust, compliant, and timely.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm Imaging Catheter as Class C.
2. Initiate product testing: Apply for the test license (MD13) via the CDSCO MD Online Portal.
3. Engage with a notified body or CDSCO for audit preparation: Find notified bodies here.
4. Compile comprehensive documentation: Use our guides to prepare master files and risk management documents.
5. Submit your manufacturing license application (Form MD7): Track status and respond to queries promptly.
6. Plan your import licensing in parallel if required: Prepare for MD15 application.

By following this structured approach and partnering with experienced consultants, you can expedite your Imaging Catheter's entry into the Indian market with full regulatory compliance and confidence.

For personalized assistance, contact our regulatory experts today and leverage our 25+ years of CDSCO licensing experience to make your medical device venture a success.