CDSCO License for Image- intensified fluoroscopic x- ray system
Medical Device Information
Intended Use
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification.
Comprehensive Guide to CDSCO Licensing for Image-Intensified Fluoroscopic X-Ray Systems
Image-intensified fluoroscopic x-ray systems represent critical medical devices in the field of interventional radiology. These systems allow clinicians to visualize anatomical structures in real-time by electronically amplifying x-ray images, aiding in minimally invasive procedures and diagnostic accuracy. Given their complexity and clinical significance, these devices are classified as Class C under the Indian medical device regulatory framework. Navigating the regulatory pathway with the Central Drugs Standard Control Organization (CDSCO) is essential for manufacturers and importers aiming to market these devices in India.
With over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we provide a detailed, step-by-step roadmap tailored for image-intensified fluoroscopic x-ray systems, ensuring your compliance journey is smooth and efficient.
CDSCO Regulatory Framework for Image-Intensified Fluoroscopic X-Ray Systems
The CDSCO regulates medical devices under the Ministry of Health and Family Welfare. According to Notification 29/Misc./03/2020-DC (146) dated 26.07.2021, image-intensified fluoroscopic x-ray systems fall under the Interventional Radiology category and are classified as Class C devices. This classification subjects them to stringent regulatory controls due to the moderate-to-high risk associated with their use.
Class C devices require a manufacturing license from the Central Licensing Authority via Form MD7 (MD9 license), and importers must obtain an MD15 import license for market entry in India.
Risk Classification and License Requirements
- Risk Class: C
- License Type: MD9 (Manufacturing License) issued by Central Licensing Authority
- Application Form: MD7 for manufacturing, MD14 for import
This classification demands compliance with enhanced safety, quality, and performance standards, including comprehensive testing and auditing.
Manufacturing License Process (MD9 License)
The manufacturing license process for Class C devices is centralized and involves several critical steps:
Test License Application (Form MD13): Before full license application, manufacturers must obtain a test license to allow sampling and testing. This phase typically takes 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-approved government laboratories to verify compliance with Indian standards. You can refer to the List of Testing Laboratories for accredited centers.
Document Preparation: Compile all required documentation, including technical files, quality management system (QMS) protocols, device master file, and risk management documentation.
Submission of Manufacturing License Application (Form MD7): Submit your application via the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors will conduct an on-site audit to verify manufacturing practices and compliance.
Query Resolution: Address any queries raised by CDSCO inspectors during the review.
Grant of License (Form MD9): Upon satisfactory review and inspection, the license is granted.
Total Timeline:
The entire process generally takes 4 to 5 months, including test license issuance, product testing, documentation, audit, and final approval.
Manufacturing License Documents Required
For the MD9 license application specific to image-intensified fluoroscopic x-ray systems, you need the following:
- Company Constitution Documents: Incorporation certificate, partnership deed, or LLP agreement.
- Proof of Ownership or Lease Agreement of Manufacturing Premises.
- Technical Staff Qualifications: Details and CVs of qualified engineers, pharmacists, or technical experts.
- Fire Safety NOC and Pollution Control Board NOC.
- Device Master File (DMF): Comprehensive technical documentation covering device design, manufacturing processes, and quality control. Our Device Master File Guide provides in-depth insights.
- Plant Master File (PMF): Details about your manufacturing site facilities and equipment. For assistance, see our Plant Master File Guide.
- Essential Principles Compliance Checklist: Affirming conformity with Indian medical device regulations.
- Risk Management File: Documented risk analysis and mitigation strategies in line with ISO 14971. Visit our Risk Management Guide for best practices.
- Test Reports: From CDSCO-approved laboratories.
- Product Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements.
- Quality Management System (QMS) Documentation: ISO 13485:2016 certification and associated SOPs.
Ensure thorough preparation of these documents for a seamless application review.
Import License Process (MD15 License)
For importers of image-intensified fluoroscopic x-ray systems, the MD15 license is mandatory:
Document Preparation: Gather all requisite documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), and your company constitution.
Application Submission: File Form MD14 for import license via the CDSCO MD Online Portal.
Review and Query Resolution: CDSCO will evaluate the submission, raise queries if needed.
License Grant: Upon satisfactory evaluation, MD15 import license is issued.
Import License Documents Required
- Valid manufacturing license from the country of origin.
- Free Sale Certificate.
- ISO 13485:2016 certification.
- CE Certificate or equivalent (if applicable).
- Device Master File and Plant Master File.
- Wholesale license (if applicable).
- Company constitution and ownership documents.
Timeline and Processing Duration
| License Type | Average Processing Time |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Manufacturing License (MD9) | 4 - 5 months |
| Import License (MD15) | 5 - 6 months |
Timelines depend heavily on the completeness of documentation and promptness in addressing CDSCO queries.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Class C) | Rs. 50,000 | Rs. 1,000 |
| MD15 (Import) | Class C & D: $3,000 per site | $1,500 per product |
Note: For the MD9 manufacturing license, additional costs include testing fees at government-approved labs and expenses related to notified body audits.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all technical files, risk assessments, and QMS documents meet CDSCO standards. Use checklists and expert reviews.
- Delays in Product Testing: Plan testing well in advance; coordinate with CDSCO-approved labs listed here.
- Audit Non-Compliance: Familiarize your facility with CDSCO audit requirements and conduct internal audits before official inspection.
- Query Management: Respond promptly and comprehensively to all CDSCO queries.
Practical tip: Engage a notified body early; check the List of Notified Bodies for your audit partner.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like image-intensified fluoroscopic x-ray systems can be complex. Our team offers:
- Expert gap analysis for your current documentation and systems.
- Customized project management from test license application to final approval.
- Training on regulatory compliance and audit readiness.
- Liaison with CDSCO officials and notified bodies.
With our proven track record, we minimize your timeline and risk of rejection.
Getting Started with Your CDSCO License Application
To initiate your CDSCO licensing process for an image-intensified fluoroscopic x-ray system:
Conduct a Device Classification Review: Confirm Class C categorization via the Medical Device Classification guide.
Prepare Your Technical Documentation: Develop Device and Plant Master Files, and compile risk management and essential principles checklists.
Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
Coordinate Testing: Book slots at government-approved laboratories early.
Schedule Pre-Audit Preparation: Conduct internal reviews and mock audits.
Submit Manufacturing License Application (Form MD7): Once testing is complete.
Engage Expert Consultants: For seamless submission and audit support.
Embarking on this process with thorough preparation and expert guidance will facilitate timely market entry and regulatory compliance for your image-intensified fluoroscopic x-ray system in India.
For personalized assistance, please contact our regulatory consulting team, leveraging over two decades of expertise in CDSCO licensing for advanced medical devices.
