CDSCO License for Radiographic film
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
Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Comprehensive Guide to CDSCO Licensing for Radiographic Film (Class A Medical Device)
Radiographic film plays a vital role in diagnostic radiology by capturing detailed images during radiologic procedures. This Class A medical device, categorized under Interventional Radiology and notified under 29/Misc./03/2020-DC (146) dated 26.07.2021, requires strict regulatory compliance to enter the Indian market. With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide you with an actionable roadmap to navigate the licensing process efficiently.
CDSCO Regulatory Framework for Radiographic Film
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules (MDR) 2017. Radiographic film, classified as a Class A device due to its low risk profile, mandates obtaining a manufacturing license (MD5) from the State Licensing Authority.
The regulatory system ensures that devices comply with safety, quality, and performance standards before market entry. Compliance with essential principles, risk management, and quality management systems (QMS) is critical.
Risk Classification and License Requirements for Radiographic Film
According to the Medical Device Classification, radiographic film falls under Class A — the lowest risk category. This classification implies that manufacturers must obtain the MD5 license (Application Form MD3) for manufacturing, which is state-level regulated.
Key points for Class A devices:
- MD5 license required for manufacturing
- Test license (MD13) mandatory before MD5 application
- Audit by a notified body
- Compliance with essential principles and risk management
Manufacturing License Process (MD5) for Radiographic Film
The MD5 license application process typically takes 3 to 4 months, encompassing several integral steps:
Test License (Form MD13) Acquisition: Before the MD5 license, manufacturers must obtain a test license to legally manufacture and test the product. This takes approximately 1.5 to 2 months.
Product Testing: Radiographic film samples must be tested in government-approved laboratories. Testing covers physical, chemical, and performance parameters.
Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documentation.
Application Submission: Submit the MD5 application (Form MD3) via the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a notified body listed in the Notified Bodies List for MD5 Audit follows the application.
Resolution of Queries: Respond promptly to any departmental or audit queries.
Grant of License: Upon satisfactory audit and document review, the MD5 license is granted on Form MD5.
Manufacturing License Documents Required
For radiographic film manufacturing license, the following documents must be meticulously compiled:
- Company Constitution and Incorporation Certificates
- Proof of Ownership/Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailing specifications, manufacturing process, raw materials (Refer our Device Master File Guide)
- Plant Master File (PMF): Outlining manufacturing facility and quality systems (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File (per Risk Management standards)
- Test Reports from Government-Approved Testing Laboratories (List of Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 preferred)
Import License Process (MD15) for Radiographic Film
If you are an importer intending to bring radiographic film into India, you must obtain an Import License (MD15) from the Central Licensing Authority. This process generally takes 5 to 6 months.
Key steps include:
- Document preparation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate.
- Submit application on the CDSCO MD Online Portal using Form MD14.
- Address queries raised by the CDSCO Central Licensing Authority.
- Obtain Import License (Form MD15).
Refer to our detailed Import License Guide for more.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Importer details
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| MD5 Application Processing | 1.5 - 2 months |
| Audit and Queries | 3 - 4 weeks |
Total Estimated Time: Approximately 3 to 4 months for manufacturing license.
Government Fees and Costs
- Application fee for MD5 license: INR 5,000
- Fee per product: INR 500
Additional costs to consider:
- Testing fees charged by government-approved labs
- Notified body audit fees
- Consultancy or regulatory support fees
Common Challenges and Solutions
Challenge: Delays in test license approval
- Solution: Prepare and submit a complete and accurate application with all necessary documents to prevent back-and-forth requests.
Challenge: Insufficient risk management documentation
- Solution: Develop a robust Risk Management File aligned with ISO 14971 standards.
Challenge: Audit non-compliance
- Solution: Conduct internal pre-audits and ensure your QMS and manufacturing processes meet notified body expectations.
Challenge: Unclear labeling and IFU
- Solution: Follow CDSCO guidelines strictly, ensuring accurate and compliant labeling.
Expert Consultation and Support
Navigating CDSCO regulations can be complex, especially for first-time applicants. With our extensive experience helping over 500 manufacturers and importers, we offer:
- Tailored regulatory strategy for radiographic film
- Assistance with document preparation including DMF and PMF
- Coordination with notified bodies and testing labs
- End-to-end application management on the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
- Assess your product classification: Confirm radiographic film as Class A.
- Prepare your technical documentation: Focus on DMF, PMF, risk management, and QMS.
- Apply for the Test License (Form MD13): Submit on the CDSCO MD Online Portal.
- Plan product testing: Coordinate with government-approved labs early.
- Schedule notified body audit: Choose a notified body from the official list and prepare your facility.
- Submit MD5 application (Form MD3): Post testing and audit readiness.
- Respond promptly to queries: Maintain active communication with CDSCO.
By following this structured approach, you can confidently secure your MD5 manufacturing license for radiographic film and enter the Indian market with compliance assured. For personalized guidance and support, connect with our expert regulatory consultants today.
