CDSCO License for Photofluorograp hic x-ray system

Comprehensive Guide to CDSCO Licensing for Photofluorographic X-ray System (Risk Class C)

As seasoned regulatory consultants with over 25 years of experience and having successfully assisted more than 500 companies, we understand the critical importance of securing the right CDSCO license for your medical device. If you manufacture or import a Photofluorographic X-ray System, classified as Risk Class C under the Indian regulatory framework, this detailed guide will help you navigate the licensing process efficiently and compliantly.

Introduction to Photofluorographic X-ray System and Regulatory Importance

A Photofluorographic X-ray System is an advanced interventional radiology device combining a fluoroscopic x-ray unit with a camera to produce and photograph fluoroscopic images of the human body. Given its critical role in diagnostics and interventional procedures, the device is classified as Class C due to moderate to high risk, necessitating stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO).

Ensuring compliance with CDSCO regulations not only guarantees patient safety but also facilitates smoother market entry and sustained business growth in India’s evolving medical device sector.

CDSCO Regulatory Framework for Photofluorographic X-ray Systems

Under the latest notification (29/Misc./03/2020-DC (146), dated 26.07.2021), Photofluorographic X-ray Systems fall under Class C medical devices. This classification mandates obtaining a Manufacturing License (MD9) from the Central Licensing Authority, administered by CDSCO.

This regulatory framework involves:

• Device testing by government-approved labs
• Submission of detailed technical and quality documentation
• On-site inspection and audit by CDSCO officials
• Compliance with Essential Principles and Risk Management standards

Risk Classification and License Requirements

Manufacturers of Class C devices must follow the MD9 license process, which is more extensive than for Class A/B devices to ensure safety and efficacy.

Manufacturing License Process for MD9 (Form MD7)

The MD9 licensing process is comprehensive and involves the following key steps:

1. Obtain Test License (Form MD13): Before applying for the manufacturing license, you must secure a test license for your device, which typically takes 1.5 to 2 months.
2. Product Testing: Conduct product testing at CDSCO-approved laboratories. Refer to the list of testing laboratories for recognized facilities.
3. Documentation Preparation: Prepare the complete dossier, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
4. Application Submission: Submit your application through the CDSCO MD Online Portal using Form MD7.
5. Audit and Inspection: CDSCO inspectors will audit your manufacturing facility and review submitted documentation.
6. Query Resolution: Address any queries or observations raised by CDSCO or auditors promptly.
7. Grant of License: Upon successful compliance, the Central Licensing Authority issues the MD9 license.

Manufacturing License Documents Required

To ensure a smooth application process, prepare the following key documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Technical Personnel Details and Qualifications
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) – Detailed design, specifications, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) – Facility layout, equipment details, and quality control procedures (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with CDSCO and international standards
• Risk Management File documenting hazard analysis and risk mitigation (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, ideally aligned with ISO 13485:2016

Import License Process for Photofluorographic X-ray System (MD15 License)

If you are an importer rather than a manufacturer, you need to obtain the MD15 import license from CDSCO’s Central Licensing Authority. The process includes:

• Comprehensive document preparation including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, and wholesale license.
• Submission of application using Form MD14 on the CDSCO MD Online Portal.
• Resolution of any regulatory queries.
• License grant typically takes 5-6 months.

Refer to our Import License Guide for detailed steps.

Timeline and Processing Duration

Government Fees and Costs

Budget for additional expenses such as document translation, legal fees, and potential re-submissions.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with Essential Principles.

Solution: Engage early with regulatory experts to prepare a robust dossier. Use checklists and templates from trusted resources.

Challenge: Difficulty in securing timely test lab slots for product testing.

Solution: Plan testing well in advance and coordinate with CDSCO-approved labs. Check the latest Testing Laboratories list.

Challenge: Audit non-compliance findings.

Solution: Conduct internal mock audits; maintain comprehensive QMS and training records.

Expert Consultation and Support

Navigating CDSCO regulations for a Class C medical device like a Photofluorographic X-ray System can be complex. Our team has empowered 500+ companies with end-to-end licensing support—from initial classification and testing to audit preparation and license grant. We provide:

• Customized regulatory strategy
• Documentation review and preparation
• Liaison with CDSCO and notified bodies
• Post-approval compliance support

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class C as per the CDSCO medical device classification system. Utilize the Medical Device Classification resource.
2. Initiate Test License Application: Apply for the Test License (MD13) on the CDSCO MD Online Portal.
3. Engage Approved Testing Labs: Schedule testing with government-approved labs to ensure timely sample analysis.
4. Prepare Comprehensive Documentation: Develop your Device and Plant Master Files, Risk Management File, and QMS documentation.
5. Submit MD9 License Application: After successful testing, submit your MD9 license application with all requisite documents.
6. Prepare for Audit: Conduct pre-audit inspections and ensure all compliance gaps are addressed.
7. Respond Promptly to Queries: Maintain open communication with CDSCO and promptly resolve any issues raised.

By following these practical steps, manufacturers and importers of Photofluorographic X-ray Systems can achieve regulatory compliance efficiently and secure market access in India.

For a detailed walkthrough tailored to your specific situation, contact our expert regulatory consultants who have decades of experience ensuring smooth CDSCO approvals.

References:

• Visit the CDSCO MD Online Portal to start your application.
• Review the list of notified bodies for audit requirements.
• Consult our MD9 License Guide for detailed insights.
• Ensure your Risk Management File meets standards using our Risk Management Guide.
• Prepare Plant Master File documents confidently with our Plant Master File Guide.

Embark on your CDSCO licensing journey today with confidence and expert support!