CDSCO License for Radiographic film marking system
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 marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.
Comprehensive Guide to CDSCO Licensing for Radiographic Film Marking System (Class A Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices such as the Radiographic Film Marking System. This device, classified under risk Class A, plays a crucial role in interventional radiology by adding essential identification details onto radiographic films via visible light exposure. With over 25 years of expertise and having supported 500+ companies, we provide an in-depth, actionable guide to obtaining your CDSCO license efficiently and compliantly.
CDSCO Regulatory Framework for Radiographic Film Marking System
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. The Radiographic Film Marking System falls under Class A, which represents low-risk devices. As per Notification 29/Misc./03/2020-DC (146) dated 26.07.2021, this device is recognized and regulated within the interventional radiology category. Compliance with CDSCO ensures the device meets safety, efficacy, and quality standards before entering the Indian market.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- Applicable License: MD5 Manufacturing License (Application Form MD3)
- Authority: State Licensing Authority
Class A devices require a streamlined regulatory pathway with relatively shorter timelines and moderate costs, compared to higher-risk classes. However, strict adherence to documentation and procedural steps is essential for successful approval.
Manufacturing License Process (MD5)
The MD5 license process involves multiple critical steps:
Test License Application (Form MD13): Before full-scale manufacturing license application, companies must obtain a test license valid for 6 months. This step typically takes 1.5 to 2 months and allows product testing in government-approved labs.
Product Testing: Radiographic Film Marking Systems must undergo testing in a CDSCO-approved laboratory to confirm compliance with relevant standards. Refer to the Testing Laboratories list for authorized facilities.
Document Preparation: Compile comprehensive technical documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) evidence.
Application Submission (Form MD3): Apply for the MD5 manufacturing license via the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit by a notified body assesses compliance of manufacturing premises and processes. You can check the list of notified bodies.
Query Resolution: Address any observations or queries raised by the CDSCO or notified body promptly.
License Grant: Upon satisfactory compliance, the MD5 license is issued in Form MD5, authorizing manufacturing of the Radiographic Film Marking System.
For detailed guidance on the MD5 license, our MD5 License Guide offers step-by-step instructions.
Manufacturing License Documents Required
For your Radiographic Film Marking System MD5 license, ensure the following documents are prepared accurately:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File guide)
- Plant Master File (PMF): Manufacturing facility layout and processes (Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documentation (ISO 13485:2016 recommended)
Completeness and accuracy of these documents significantly reduce delays during the audit and review stages.
Import License Process (MD15)
If you are an importer of the Radiographic Film Marking System, an MD15 import license from the Central Licensing Authority is mandatory before bringing the device into India. The process includes:
- Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files
- Submission of application via CDSCO MD Online Portal
- Resolution of any queries from the department
- License grant typically within 5-6 months
For more insight, explore our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| MD5 License Application (MD3) | 7 – 10 days |
| Notified Body Audit | 4 – 6 weeks |
| Query Resolution & Grant | 2 – 3 weeks |
Total Estimated Time: Approximately 3 to 4 months
Planning ahead and maintaining proactive communication with CDSCO and notified bodies can help stay within these timelines.
Government Fees and Costs
- Test License (Form MD13): No separate fee
- MD5 Manufacturing License: ₹5,000 per application + ₹500 per product
- Testing and Audit Costs: Variable, depending on notified body and lab fees (typically ₹50,000 to ₹1,00,000)
Budgeting for these expenses upfront avoids surprises during the licensing process.
Common Challenges and Solutions
- Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. Conduct a thorough internal audit before submission.
- Test Report Rejection: Use only CDSCO-approved labs and verify test protocols align with Indian standards.
- Audit Non-Compliance: Prepare manufacturing sites per notified body checklists; pre-audit mock inspections are highly recommended.
- Slow Query Responses: Assign dedicated personnel for regulatory communication to ensure timely replies.
Our extensive hands-on experience enables us to anticipate and mitigate these hurdles efficiently.
Expert Consultation and Support
With more than 25 years of regulatory consulting experience and a track record of 500+ successful CDSCO licenses, we provide:
- Tailored document preparation assistance
- Liaison with notified bodies and CDSCO
- Pre-audit readiness assessments
- Comprehensive training on Indian regulatory requirements
Partnering with experts significantly enhances your chances of timely license approval.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your Radiographic Film Marking System as Class A (Medical Device Classification).
Initiate Test License Application: Submit Form MD13 for your test license via the CDSCO MD Online Portal.
Engage Certified Testing Labs: Schedule product testing promptly to avoid bottlenecks.
Prepare Comprehensive Documentation: Utilize our Device and Plant Master File guides to streamline preparation.
Apply for MD5 License: Once test reports are available, file Form MD3 online and arrange for notified body audit.
Respond to Queries Swiftly: Maintain open lines with CDSCO and notified bodies to resolve any observations.
By following these targeted steps, you position your Radiographic Film Marking System for successful entry into the Indian market with a valid CDSCO license.
