CDSCO License for Cine or spot fluorographic x-  ray camera

Comprehensive Guide to CDSCO Licensing for Cine or Spot Fluorographic X-ray Cameras (Class C Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized equipment like the cine or spot fluorographic x-ray camera. This device, classified under Class C due to its moderate to high risk, plays a vital role in interventional radiology by capturing diagnostic images via x-rays using an image intensifier. Understanding the CDSCO licensing process is critical for manufacturers and importers aiming to enter the Indian market efficiently and compliantly.

With over 25 years of experience and having assisted more than 500 companies in securing CDSCO approvals, we provide you with an expert, detailed roadmap to obtaining your manufacturing or import license for this device.

CDSCO Regulatory Framework for Cine or Spot Fluorographic X-ray Cameras

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Devices Rules 2017. Your cine or spot fluorographic x-ray camera falls under the interventional radiology category and is notified under the gazette notification 29/Misc./03/2020-DC (146) dated 26.07.2021.

As a Class C device, regulatory oversight is stringent, requiring central licensing authority involvement. This ensures safety, efficacy, and compliance with Indian and international standards.

Risk Classification and License Requirements

The cine or spot fluorographic x-ray camera is categorized as a Class C medical device, which denotes moderate to high risk. This classification dictates the licensing pathway:

• Manufacturing License: Requires an MD9 license granted by the CDSCO Central Licensing Authority.
• Import License: Requires an MD15 license granted by CDSCO.

This classification mandates more rigorous testing, documentation, and audit processes compared to Class A or B devices.

Manufacturing License Process (MD9)

Obtaining the MD9 license is a multi-step process:

1. Test License (Form MD13): Initially, you must apply for a test license to manufacture samples for testing. This process takes approximately 1.5 to 2 months.
2. Product Testing: Samples must be tested at government-approved testing laboratories to validate safety and performance.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission (Form MD7): Apply for the manufacturing license on the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct a detailed audit of your manufacturing facility and documentation.
6. Queries Resolution: Address any observations or queries raised by the CDSCO or audit team promptly.
7. License Grant (Form MD9): Upon satisfactory compliance, the MD9 manufacturing license is granted.

For detailed guidance on the MD9 process, refer to our MD9 License Guide.

Manufacturing License Documents Required

To ensure a smooth licensing process, gather the following documents:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOC certificates
• Device Master File (DMF) detailing design, specifications, and manufacturing processes
• Plant Master File (PMF) showcasing the manufacturing environment and quality controls
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File (in line with ISO 14971)
• Test Reports from government-approved laboratories (list of testing laboratories)
• Labels and Instructions for Use (IFU) as per regulatory guidelines
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

We recommend reviewing our detailed guides on creating Device Master Files and Plant Master Files to ensure thorough documentation.

Import License Process (MD15)

Importers of cine or spot fluorographic x-ray cameras must obtain an MD15 import license from CDSCO Central Licensing Authority. The process typically spans 5 to 6 months and includes:

1. Document Preparation: Collate all necessary certificates and licenses, including your manufacturing license from the country of origin.
2. Application Submission (Form MD14): Submit the import license application through the CDSCO MD Online Portal.
3. Queries Resolution: Address any clarifications or additional information requested by CDSCO.
4. License Grant (Form MD15): After thorough review, CDSCO issues the import license.

Unlike manufacturing licenses, an MD15 import license does not require a test license but demands comprehensive documentation.

Import License Documents Required

Essential documents for the MD15 license include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 certification
• CE Certificate or equivalent international conformity certificate
• Device Master File and Plant Master File
• Wholesale license or distribution authorization in India
• Company Constitution documents

For an in-depth overview, consult our Import License Guide.

Timeline and Processing Duration

These timelines are averages and can vary depending on application completeness and responsiveness to queries.

Government Fees and Costs

• MD9 License:

  • Application fee: ₹50,000 per application
  • Product fee: ₹1,000 per product

• MD15 License:

  • Class C & D devices: ₹3,000 per site + ₹1,500 per product

Additional costs include testing fees at government-approved labs and audit expenses. Budgeting for these upfront can help avoid delays.

Common Challenges and Solutions

• Incomplete Documentation: Missing or improperly compiled documents are the leading cause of delays. Utilize checklists and expert reviews to ensure completeness.
• Test Report Delays: Testing at approved laboratories can be time-consuming. Engage with labs early and schedule testing to avoid bottlenecks.
• Audit Non-Compliance: Facility audits require strict adherence to QMS and regulatory standards. Conduct internal mock audits and staff training ahead of inspections.
• Query Management: Slow or inadequate responses to CDSCO queries prolong processing. Assign dedicated regulatory personnel to monitor and respond promptly.

By proactively addressing these pain points, manufacturers and importers can significantly streamline the approval process.

Expert Consultation and Support

Our team has successfully guided over 500 medical device companies through the CDSCO regulatory maze. We offer end-to-end support including:

• Gap analysis and document preparation
• Coordination with notified bodies and testing laboratories
• Audit readiness and compliance training
• Application submission and post-submission follow-up

Take advantage of our deep regulatory expertise to minimize risks and expedite your market entry.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Verify your cine or spot fluorographic x-ray camera as Class C via the Medical Device Classification resource.
2. Prepare Testing Samples: Apply for a test license (Form MD13) through the CDSCO MD Online Portal.
3. Engage Testing Laboratories: Coordinate testing at government-approved labs early to avoid delays.
4. Compile Documentation: Start assembling your Device Master File, Plant Master File, and Risk Management File per regulatory standards.
5. Plan for Audit: Identify and appoint a notified body if required and prepare for CDSCO inspections.
6. Submit Application: File your manufacturing license application (Form MD7) or import license application (Form MD14) via the CDSCO portal.

Partnering with a seasoned regulatory consultant can help you navigate these steps seamlessly, ensuring your cine or spot fluorographic x-ray camera reaches the Indian healthcare market without unnecessary hurdles.

For personalized assistance, reach out to our expert team today.