CDSCO License for Radiographic intensifying screen

Comprehensive Guide to CDSCO Licensing for Radiographic Intensifying Screens (Class A Medical Device)

Radiographic intensifying screens play a pivotal role in interventional radiology by converting x-ray photons into visible light, enhancing the exposure of radiographic films for precise medical imaging. As a Class A medical device under CDSCO regulations, manufacturers and importers must navigate specific regulatory pathways to legally market these devices in India. Leveraging over 25 years of regulatory consulting experience and assisting 500+ companies, we provide you with a detailed, practical roadmap to secure your CDSCO license efficiently.

Understanding the CDSCO Regulatory Framework for Radiographic Intensifying Screens

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Radiographic intensifying screens fall under Class A, the lowest risk category, as per the notification [29/Misc./03/2020-DC (146)] dated 26.07.2021. This classification mandates compliance with the Medical Device Rules (MDR) 2017 and related amendments, ensuring safety and performance standards are met before market entry.

Risk Classification and License Requirements for Your Device

Being a Class A device, the radiographic intensifying screen requires an MD5 manufacturing license granted by the State Licensing Authority. The MD5 license process incorporates:

• Test license (Form MD13) for initial product testing
• Product testing at government-approved laboratories
• Submission of a comprehensive application (Form MD3)
• Audit by a notified body

For importers, an MD15 license from the Central Licensing Authority is necessary, involving a distinct but similarly rigorous procedure.

Manufacturing License Process (MD5) for Class A Devices

1. Test License (Form MD13): Initiate the process by applying for a test license, valid for 3 months, during which product testing is conducted.
2. Product Testing: Get your radiographic intensifying screen tested at government-recognized labs to verify compliance with applicable standards. Refer to the list of approved testing laboratories for selecting your testing partner.
3. Application Preparation: Prepare your MD5 license application (Form MD3) incorporating all required documents.
4. Submission & Audit: Submit your application via the CDSCO MD Online Portal. Subsequently, a notified body conducts a thorough audit of your manufacturing site and quality management system. Find notified bodies for audits here.
5. Query Resolution: Address any observations or queries raised by the authorities promptly.
6. License Grant: Once compliant, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required

Ensure meticulous preparation of the following critical documents:

• Company constitution and incorporation certificates
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and pollution no-objection certificates (NOCs)
• Device Master File detailing design, specifications, and manufacturing process (See our Device Master File guide)
• Plant Master File outlining manufacturing infrastructure and equipment (Refer to our Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with safety and performance
• Risk Management File addressing potential hazards and mitigation (Learn more about Risk Management)
• Product test reports from accredited labs
• Labels and Instructions For Use (IFU) complying with CDSCO standards
• Quality Management System (QMS) documentation aligned with ISO 13485:2016

Import License Process (MD15) for Radiographic Intensifying Screens

If you intend to import radiographic intensifying screens, an MD15 license is mandatory. The steps include:

• Document preparation including your manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files
• Application submission on the CDSCO MD Online Portal using Form MD14
• Resolution of any queries posed by CDSCO
• Final grant of the MD15 import license

Note that unlike manufacturing licenses, a test license is not required for import licenses. The process typically spans 5-6 months.

Import License Documents Required

• Valid manufacturing license issued by the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale drug license if applicable
• Company constitution documents

Timeline and Processing Duration

Government Fees and Costs

For manufacturing radiographic intensifying screens (Class A) under MD5 license:

• Application fee: ₹5,000 per application
• Product fee: ₹500 per product

Import license fees under MD15 vary by device class; for Class A devices, expect approximately $1,000 per site plus$50 per product.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to laboratory backlog.

Solution: Engage early with approved testing labs and submit samples promptly after receiving the test license.

Challenge: Incomplete or inconsistent documentation causing audit observations.

Solution: Use our comprehensive checklists and templates for the Device and Plant Master Files and ensure QMS documents meet ISO standards.

Challenge: Query resolution delays due to lack of clarity.

Solution: Maintain open communication with CDSCO officers and respond to queries clearly and promptly, supported by evidence.

Expert Consultation and Support

Navigating CDSCO licensing intricacies requires expert guidance. Our team has successfully helped over 500 companies obtain licenses for Class A devices like radiographic intensifying screens. We offer end-to-end support including document preparation, liaison with notified bodies, and audit readiness to streamline your licensing journey.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your device is Class A under CDSCO rules using the Medical Device Classification resource.
2. Prepare essential documentation: Begin compiling your Device Master File, Plant Master File, and QMS documentation.
3. Apply for test license (MD13): Submit your application through the CDSCO MD Online Portal to initiate product testing.
4. Coordinate product testing: Select an approved testing laboratory and dispatch samples promptly.
5. Develop a compliance roadmap: Plan for audit scheduling and pre-audit readiness with a notified body.
6. Submit your MD5 license application: Once testing is successful and documentation is complete, file the application using Form MD3.

Embarking on your CDSCO licensing process with clear, actionable steps and experienced guidance ensures timely market access for your radiographic intensifying screens. Contact us today to leverage our proven expertise and accelerate your regulatory approvals.