CDSCO License for Software for using with mammography- combined diagnostic X- ray system
Medical Device Information
Intended Use
A software, which is designed to processes data obtained from a combined diagnostic mammography-radiography system.
Comprehensive Guide to CDSCO Licensing for Software Used with Mammography – Combined Diagnostic X-Ray System (Class B Medical Device)
With over 25 years of experience assisting more than 500 medical device companies, we understand the critical nuances involved in navigating the CDSCO licensing pathway for software devices, especially those like the Software for use with Mammography – Combined Diagnostic X-Ray Systems classified as Class B devices. This software plays a pivotal role in processing data from combined diagnostic mammography-radiography systems, a key diagnostic tool in breast cancer screening and diagnosis.
Understanding the CDSCO Regulatory Framework for Mammography Software (Class B Medical Device)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. As per the notification [29/Misc./03/2020-DC (198)] dated 13.09.2021, software intended to process data obtained from combined diagnostic mammography-radiography systems falls under Class B risk category. This classification mandates adherence to regulatory provisions including licensing, quality management, testing, and audits.
Risk Classification and Licensing Requirements for Class B Medical Software
Class B devices represent low to moderate risk and require a State Licensing Authority approval for manufacturing licenses (MD5 license). This contrasts with Class C and D devices which require Central Licensing Authority approval (MD9 license).
Specifically for software related to diagnostic imaging:
- Risk Class: B
- Applicable License: MD5 (Manufacturing License for Class A and B devices)
- Regulatory Authority: State Licensing Authority
This classification means the entire licensing process includes a test license, product testing, document submission, audit by a notified body, followed by license grant.
Detailed Manufacturing License Process (MD5) for Software Devices
The MD5 licensing process can be broken down into distinct steps:
Test License Application (Form MD13): Obtain a test license to legally manufacture the software prototype for testing. This typically takes 1.5 to 2 months.
Product Testing: The software must be tested at CDSCO-approved government labs to verify conformity with safety and performance standards. Refer to the list of testing laboratories for authorized facilities.
Document Preparation: In parallel, prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, QMS documents, and others.
License Application Submission: File the license application via the CDSCO MD Online Portal using Form MD3.
Notified Body Audit: A qualified notified body conducts an onsite audit of your manufacturing facility and QMS. Check the list of notified bodies for authorized auditors.
Query Resolution: Address any queries raised by CDSCO or the notified body promptly to avoid delays.
Grant of MD5 License: Upon successful audit and document approval, the State Licensing Authority issues the manufacturing license on Form MD5.
Essential Documents Required for MD5 License Application
For Class B software devices like the mammography diagnostic software, the following are mandatory:
- Company Constitution documents (e.g., Incorporation Certificate)
- Proof of ownership or valid lease of manufacturing premises
- Qualification and experience certificates of technical personnel
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design, development, and validation data. Our Device Master File guide explains preparation best practices.
- Plant Master File (PMF): Details of manufacturing premises, processes, and quality systems.
- Essential Principles Compliance Checklist confirming alignment with the regulatory safety requirements
- Risk Management File demonstrating hazard analysis and mitigation measures. Learn more about risk management implementation.
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 compliance evidence
Import License Process (MD15) for Mammography Software
While the focus here is on manufacturing licenses, importers must obtain an MD15 import license from the Central Licensing Authority. The MD15 license application uses Form MD14 and generally takes about 5-6 months. Requirements include a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), DMF, PMF, and wholesale license.
More details can be found in our Import License Guide.
Timeline and Processing Duration for MD5 License
- Test License (MD13): 1.5 to 2 months
- Product Testing: 1 to 1.5 months depending on lab capacity
- Document Preparation: Can be concurrent but typically 1 month
- Application Submission and Audit: 1 to 1.5 months
- Total Duration: Approximately 3 to 4 months from start to finish
Government Fees and Cost Structure for Class B Software Devices
- Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
Note that these fees are payable via the CDSCO MD Online Portal at the time of application submission.
Common Challenges and Practical Solutions
Challenge 1: Delayed product testing due to lab backlogs
- Solution: Engage with CDSCO-approved labs early and schedule testing slots in advance.
Challenge 2: Incomplete documentation causing audit delays
- Solution: Utilize comprehensive checklists and expert consultation to ensure all required documents, such as the DMF and PMF, are complete and up-to-date.
Challenge 3: Non-compliance with Essential Principles
- Solution: Conduct thorough internal audits against the Essential Principles Checklist before submission.
Challenge 4: Audit scheduling conflicts with notified bodies
- Solution: Coordinate early with notified bodies listed on the CDSCO Notified Bodies List to confirm availability.
Expert Consultation and Support
Our extensive experience in CDSCO licensing enables us to provide tailored support—from initial classification advice to document preparation, audit facilitation, and post-approval compliance. We have successfully guided over 500 companies through the complex regulatory landscape for software medical devices.
Getting Started with Your CDSCO License Application for Mammography Software
Confirm Device Classification: Verify your software device’s classification as Class B using resources such as the Medical Device Classification guide.
Prepare Test License Application: Initiate your test license (Form MD13) via the CDSCO MD Online Portal.
Coordinate Testing: Identify and engage with an appropriate government-approved testing laboratory early.
Compile Documentation: Begin assembling your Device Master File, Plant Master File, Risk Management File, and other required documents.
Plan for Audit: Schedule the notified body audit in advance to align with your license application timeline.
Engage Expert Consultants: Consider partnering with experienced regulatory consultants to streamline the process, minimize errors, and reduce approval timelines.
By following these actionable steps and leveraging expert support, manufacturers of mammography diagnostic software can efficiently navigate the CDSCO licensing process, ensuring timely market entry and compliance with Indian regulatory standards.
