CDSCO License for Diagnostic x-ray high voltage generator

Comprehensive Guide to CDSCO Licensing for Diagnostic X-ray High Voltage Generators (Class A Medical Device)

Diagnostic x-ray high voltage generators are specialized devices designed to supply and regulate the electrical energy applied to diagnostic x-ray tubes, critical in medical imaging within the interventional radiology category. Given their medical significance and associated risks, these devices fall under Class A as per the CDSCO's risk classification and require strict regulatory compliance before marketing in India.

With over 25 years of experience assisting 500+ companies in successfully navigating CDSCO licensing, we provide you with a detailed roadmap to obtain your manufacturing license for this device.

CDSCO Regulatory Framework for Diagnostic X-ray High Voltage Generators

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Under the Medical Devices Rules, 2017, diagnostic x-ray high voltage generators are regulated as Class A devices due to their low risk profile.

This device is notified under Notification Number 29/Misc./03/2020-DC (146), dated 26.07.2021, which classifies it within the interventional radiology category. Compliance with CDSCO ensures safety, efficacy, and quality assurance for end users.

Risk Classification and License Requirements

Your diagnostic x-ray high voltage generator is a Class A device. According to CDSCO:

• Class A and B devices require an MD5 manufacturing license obtained via Form MD3.
• The licensing authority is the State Licensing Authority.
• The entire licensing process typically spans 3 to 4 months.

Being a Class A device, the regulatory requirements are comparatively simplified but still demand strict adherence to documentation, testing, and audit protocols.

Manufacturing License Process (MD5 License)

The MD5 license process for your device involves the following steps:

1. Test License Application (Form MD13): Before full manufacturing license application, obtain a test license which allows limited manufacturing for testing.
2. Product Testing: Conduct product testing at CDSCO-approved government laboratories.
3. Document Preparation: Prepare comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and other quality system documents.
4. Submit Application (Form MD3): Apply for the MD5 manufacturing license via the CDSCO MD Online Portal.
5. Notified Body Audit: An audit by a notified body is mandatory to verify compliance.
6. Query Resolution: Address any queries from the CDSCO or notified body promptly.
7. License Grant: Upon successful review, receive the MD5 license on Form MD5.

You can submit your application through the CDSCO MD Online Portal.

Manufacturing License Documents Required

For the diagnostic x-ray high voltage generator (Class A), ensure the following documents are meticulously prepared:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Refer to our comprehensive Device Master File guide.
• Plant Master File (PMF) covering manufacturing environment and quality systems. See our Plant Master File Guide.
• Essential Principles Checklist to demonstrate compliance with safety and performance requirements
• Risk Management File aligned with ISO 14971 standards. Learn best practices in our Risk Management guide.
• Test Reports from CDSCO-approved laboratories. Check the list of Testing Laboratories.
• Labels, Instructions for Use (IFU), and packaging details
• Quality Management System (QMS) documents demonstrating compliance with ISO 13485:2016

Import License Process (MD15 License)

If you intend to import diagnostic x-ray high voltage generators instead of manufacturing locally, an MD15 import license is mandatory.

• The MD15 license is granted by the Central Licensing Authority under CDSCO.
• The process takes approximately 5 to 6 months.
• Unlike manufacturing licenses, a test license is not required.
• Application is made on Form MD14 for MD15 license.
• Required documents include Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.

Government fees for Class A devices are approximately $1000 per site plus$50 per product.

For detailed guidance, refer to our Import License guide.

Timeline and Processing Duration

Total expected timeline: Approximately 3 to 4 months for MD5 manufacturing license.

Government Fees and Costs

For Class A diagnostic x-ray high voltage generators:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include:

• Testing fees charged by government-approved labs
• Notified body audit fees (vary by agency)
• Consultancy or document preparation charges (if outsourcing)

Planning your budget accordingly is crucial to avoid delays.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Initiate testing early and select CDSCO-approved laboratories with capacity. Check the latest Testing Laboratories list.

Challenge 2: Incomplete Documentation

• Solution: Use checklists and templates for Device Master File and Plant Master File. Our guides provide step-by-step help.

Challenge 3: Audit Non-conformities

• Solution: Pre-audit internal assessments and training for staff to ensure compliance with QMS.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with clear, factual information supported by documentation.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for highly technical devices like diagnostic x-ray high voltage generators. Our team has supported over 500 companies, ensuring smooth application, document preparation, and audit readiness.

We offer tailored solutions including:

• Document drafting and review
• Risk management implementation
• Coordinating product testing and notified body audits
• Liaising with CDSCO officials to expedite query resolution

Getting Started with Your CDSCO License Application

1. Assess your device classification: As a Class A device, ensure you meet MD5 license criteria.
2. Prepare your technical documentation: Start compiling your Device Master File, Plant Master File, and Risk Management File.
3. Apply for the Test License (MD13): This is a prerequisite for manufacturing license application.
4. Schedule product testing: Coordinate with CDSCO-approved labs early.
5. Plan audit readiness: Engage a notified body from the Notified Bodies List.
6. Submit your application: Use the CDSCO MD Online Portal for all submissions.

We recommend beginning well in advance to accommodate unforeseen delays and ensure compliance.

For personalized assistance, reach out to our regulatory experts who can guide you through every step of the CDSCO licensing process for your diagnostic x-ray high voltage generator.

By adhering to this comprehensive roadmap, manufacturers and importers can confidently navigate the regulatory landscape, ensuring timely market entry and sustained compliance for this critical medical device.