CDSCO License for Radiographic film illuminator
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs
Comprehensive Guide to CDSCO Licensing for Radiographic Film Illuminators (Class A)
Radiographic film illuminators play a crucial role in diagnostic radiology by providing a controlled light source to accurately view medical radiographs. Classified as Class A devices under the interventional radiology category, these devices have a low risk profile, which influences their regulatory pathway in India. With the CDSCO notification 29/Misc./03/2020-DC (146) dated 26.07.2021, compliance requirements have been clearly outlined for manufacturers and importers aiming to enter the Indian market.
Having supported over 500 medical device companies in obtaining CDSCO licenses, we understand the nuances involved in navigating the regulatory landscape for devices like radiographic film illuminators. This detailed guide covers everything you need to know—from classification and licensing processes to practical tips ensuring a smooth approval journey.
CDSCO Regulatory Framework for Radiographic Film Illuminators
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Since radiographic film illuminators fall under Class A devices (low risk), the regulatory framework is designed to be straightforward, balancing safety with ease of market access.
Notifications such as 29/Misc./03/2020-DC (146) provide the legal backing for these classifications and define the exact requirements manufacturers and importers must meet. Adherence to these regulations ensures your product is compliant with Indian standards and ready for commercial distribution.
Risk Classification and License Requirements
Radiographic film illuminators are classified as Class A devices. According to CDSCO:
- Class A Devices: Low risk
- License Type: MD5 Manufacturing License (if manufacturing in India)
- Licensing Authority: State Licensing Authority
- Application Form: MD3 for manufacturing license
This classification means the product is subject to state-level licensing, which typically has shorter processing times and lower fees compared to higher-risk classes.
Manufacturing License Process (MD5) for Radiographic Film Illuminators
For manufacturers intending to produce radiographic film illuminators in India, obtaining an MD5 license is mandatory. The process involves several key steps:
Test License (Form MD13): Initially, you must apply for a test license, which allows for product testing. This takes around 1.5 to 2 months.
Product Testing: Testing must be conducted at CDSCO-recognized testing laboratories to validate product safety and performance. You can refer to the list of testing laboratories to select an approved facility.
Document Preparation: Compile all required documentation, including technical and quality files.
Application Submission (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit of your manufacturing facility will be conducted by a notified body listed on the CDSCO portal, ensuring compliance with quality management systems and regulatory requirements. Check the notified bodies list to identify authorized auditors.
Query Resolution: Address any queries raised during the audit or application review promptly to avoid delays.
License Grant (Form MD5): Upon successful completion, the manufacturing license is granted, authorizing production.
The entire process typically takes 3 to 4 months.
Manufacturing License Documents Required for Radiographic Film Illuminators
To streamline your application, ensure you have the following documentation ready:
- Company Constitution (e.g., incorporation certificate)
- Proof of ownership or lease of manufacturing premises
- Technical staff qualifications and experience proofs
- Fire and Pollution NOCs (No Objection Certificates)
- Device Master File (DMF): Detailed documentation on device design, intended use, and technical specifications. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Information about your manufacturing facility, equipment, and processes. Refer to our Plant Master File guide for best practices.
- Essential Principles Checklist ensuring compliance with regulatory standards
- Risk Management File documenting hazard analysis and mitigation, as detailed in our Risk Management guide
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, typically ISO 13485:2016 certification
Import License Process (MD15) for Radiographic Film Illuminators
If you are an importer of radiographic film illuminators, you must obtain an MD15 import license from the Central Licensing Authority. The process involves:
Document Compilation: Prepare necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
Queries and Clarifications: Respond to any department queries promptly.
License Grant (Form MD15): Upon approval, the import license is issued.
Import licensing generally takes 5 to 6 months.
Import License Documents Required
Key documents for MD15 import license include:
- Valid manufacturing license from the country of origin
- Free Sale Certificate (certifying the product is sold freely in the country of origin)
- ISO 13485:2016 certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
Timeline and Processing Duration
| License Type | Processing Time | Key Milestones |
|---|---|---|
| MD5 Manufacturing | 3-4 months | Test license (1.5-2 months), product testing, audit, license grant |
| MD15 Import | 5-6 months | Document review, queries, license grant |
Planning your project timelines with these durations in mind is essential to avoid market entry delays.
Government Fees and Costs for Radiographic Film Illuminators
For your Class A radiographic film illuminator:
MD5 License:
- Application fee: Rs 5,000
- Per product fee: Rs 500
MD15 Import License:
- Site fee: $1,000
- Per product fee: $50
Additional costs may include testing fees, audit charges, and consultancy fees if you opt for expert assistance.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with CDSCO-recognized laboratories early and confirm testing schedules. Prioritize submission of complete samples and documentation to avoid retesting.
Challenge 2: Incomplete or Non-compliant Documentation
- Solution: Use checklists and expert reviews to ensure all files, especially Device and Plant Master Files, meet CDSCO standards.
Challenge 3: Audit Non-conformities
- Solution: Conduct pre-audit internal assessments and train your technical and quality teams thoroughly.
Challenge 4: Regulatory Queries and Clarifications
- Solution: Respond promptly and accurately, providing supporting evidence and referencing regulatory guidelines.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, especially when balancing technical, regulatory, and operational demands. With over 25 years of experience and a track record of assisting 500+ companies, we provide tailored consulting services to:
- Prepare and review comprehensive Device and Plant Master Files
- Facilitate product testing with government-approved labs
- Coordinate audits with notified bodies
- Assist in timely resolution of regulatory queries
- Streamline application submission via the CDSCO MD Online Portal
Our clients benefit from minimized delays, optimized costs, and increased approval success rates.
Getting Started with Your CDSCO License Application for Radiographic Film Illuminators
To initiate your CDSCO licensing journey, follow these practical steps:
Assess Device Classification: Confirm your device’s Class A status using CDSCO guidelines or our Medical Device Classification resource.
Prepare Documentation: Begin compiling your Device Master File and Plant Master File with detailed technical and manufacturing information.
Apply for Test License: Submit Form MD13 for the test license via the CDSCO MD Online Portal. This step is critical before manufacturing license application.
Schedule Product Testing: Coordinate with approved testing laboratories early to avoid bottlenecks.
Plan Your Audit: Identify and liaise with notified bodies for facility audits once product testing is complete.
Submit Manufacturing License Application: Complete Form MD3 submission through the CDSCO portal.
Prepare for Queries: Allocate resources to promptly address any department or auditor queries.
Obtain License and Commence Manufacturing: Upon license grant (MD5), you are authorized to manufacture and distribute radiographic film illuminators in India.
For importers, the process starts with document compilation and Form MD14 submission for MD15 license.
By following these steps and leveraging expert advice, your radiographic film illuminator can successfully navigate the CDSCO regulatory process, ensuring timely market access and regulatory compliance.
For personalized support or detailed consultancy, reach out to our team of seasoned regulatory experts ready to guide you through every stage of CDSCO licensing.
