CDSCO License for Non-image- intensified fluoroscopic x-  ray system

Introduction to Non-image-intensified Fluoroscopic X-ray Systems and Regulatory Importance

Non-image-intensified fluoroscopic x-ray systems are vital devices used in interventional radiology to visualize anatomical structures through a fluorescent screen converting x-radiation into visible images. This device, classified as Class C under the Indian medical device regulatory framework, demands stringent regulatory compliance before market entry. Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is critical for manufacturers and importers to ensure safety, efficacy, and legal clearance for commercialization in India.

With over 25 years of experience and having assisted 500+ companies, we provide you with an in-depth and pragmatic guide to securing the CDSCO license for this high-risk medical device.

CDSCO Regulatory Framework for Non-image-intensified Fluoroscopic X-ray Systems

The CDSCO, under the Ministry of Health and Family Welfare, governs the regulation of medical devices in India. Non-image-intensified fluoroscopic x-ray systems fall under the notified list as per Notification 29/Misc./03/2020-DC (146) dated 26.07.2021. Being Class C devices, these systems require central licensing authority approval through the MD9 license process.

The regulatory framework ensures compliance with Indian Medical Device Rules (MDR) 2017 and mandates rigorous testing, documentation, and auditing to ensure patient safety and device performance.

Risk Classification and License Requirements

Class C devices are categorized as moderate to high-risk medical devices, necessitating a thorough regulatory review. According to the Medical Device Classification guidelines, your non-image-intensified fluoroscopic x-ray system requires an MD9 manufacturing license for domestic production and an MD15 import license if the device is to be imported.

The MD9 license is granted by the CDSCO Central Licensing Authority and involves comprehensive documentation, testing, and factory inspections.

Manufacturing License Process (MD9)

The pathway to obtaining an MD9 manufacturing license for a Class C device like this involves several key steps:

1. Test License Application (Form MD13): Initially, apply for a test license that allows you to manufacture the device for testing purposes. This process typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to verify compliance with essential principles. Refer to the Testing Laboratories list to select an accredited lab.

3. Document Preparation: Prepare all required documents including Device Master File (DMF), Plant Master File (PMF), and Risk Management File.

4. Application Submission (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Factory Inspection: CDSCO inspectors will audit your manufacturing site to verify compliance with Good Manufacturing Practices (GMP).

6. Query Resolution: Address any queries raised by the authority or inspectors promptly.

7. License Grant: Upon satisfactory review and inspection, the MD9 license will be granted.

For a detailed walkthrough, our MD9 License Guide offers step-by-step assistance.

Manufacturing License Documents Required

To ensure smooth processing, prepare the following essential documents:

• Company Constitution Documents: Certificate of Incorporation, Memorandum and Articles of Association.
• Proof of Ownership or Lease of Manufacturing Premises.
• Technical Staff Qualifications: CVs and certificates of key personnel.
• Fire and Pollution NOCs: Mandatory clearances from local authorities.
• Device Master File: Detailed design, manufacturing, and performance data. Our Device Master File guide can help you compile this effectively.
• Plant Master File: Description of manufacturing facility, equipment, and quality systems. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Demonstrate compliance with Indian MDR essential principles.
• Risk Management File: Documentation per ISO 14971 standards. Learn more about Risk Management.
• Test Reports: From CDSCO-approved labs.
• Labels and Instructions for Use (IFU): As per regulatory standards.
• Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification and SOPs.

Import License Process (MD15)

If you plan to import this device, apply for the MD15 import license granted by the CDSCO Central Licensing Authority. The process includes:

• Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO and CE certificates.
• Application Submission: Via the CDSCO MD Online Portal.
• Query Resolution: Respond to any department queries.
• License Grant: Typically takes 5-6 months.

Refer to our Import License Guide for a detailed roadmap.

Import License Documents Required

Key documents for MD15 include:

• Valid manufacturing license from the country of origin.
• Free Sale Certificate.
• ISO 13485:2016 certification.
• CE Certificate or equivalent.
• Device Master File and Plant Master File.
• Wholesale License in India.
• Company Constitution documents.

Timeline and Processing Duration

The entire MD9 license process for your Class C device typically takes around 4-5 months, considering the test license, product testing, document preparation, and inspection.

Government Fees and Costs

For Class C devices under MD9 license:

• Application Fee: Rs 50,000 per application.
• Per Product Fee: Rs 1,000 per product.

Additional costs include:

• Testing laboratory fees (varies by device complexity and tests required).
• Audit fees, if applicable.

Budgeting for these expenses early in your planning phase is crucial to avoid delays.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Partner with CDSCO-approved laboratories early and pre-schedule testing slots.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists and expert consultancy to ensure all technical and administrative documents are complete.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal pre-audits and staff training to meet GMP and QMS requirements.

Challenge 4: Regulatory Queries

• Solution: Respond promptly with clear, evidence-backed replies to avoid hold-ups.

Expert Consultation and Support

With our extensive experience assisting over 500+ companies, we offer tailored regulatory consulting to streamline your CDSCO licensing journey. Our services include:

• Complete documentation preparation including DMF and PMF.
• Coordinating product testing with accredited laboratories.
• Audit readiness and mock inspections.
• Regulatory strategy and risk management implementation.

Leverage our expertise to mitigate risks and accelerate your time to market.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device as Class C using the official Medical Device Classification resources.

2. Prepare Documentation: Begin compiling your Device Master File and Plant Master File, referencing our dedicated guides.

3. Apply for Test License (MD13): Submit your initial application via the CDSCO MD Online Portal to begin manufacturing for testing.

4. Schedule Product Testing: Coordinate with a CDSCO-approved testing laboratory promptly.

5. Plan for Audit: Prepare your facility and QMS for CDSCO inspection.

6. Submit MD9 Application: Once test reports are in, apply for the manufacturing license and manage any follow-up queries efficiently.

Starting early, staying organized, and engaging expert support can significantly smooth your regulatory pathway. Contact us to begin your CDSCO licensing journey for your non-image-intensified fluoroscopic x-ray system today.