CDSCO License for Software for urodynamic measurement system
Medical Device Information
Intended Use
A software, which is designed to process data obtained from a urodynamic measurement system. The resultant data are provided for diagnosis, etc.
Comprehensive Guide to CDSCO Licensing for Software Urodynamic Measurement Systems (Class B)
As a trusted regulatory consultancy with over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we understand the nuances and challenges of bringing medical device software into the Indian market. This guide specifically addresses the regulatory pathway for the Software for Urodynamic Measurement System, classified as a Class B medical device under CDSCO notification 29/Misc./03/2020-DC (198) dated 13.9.2021.
Understanding the Device and Its Regulatory Importance
Software for urodynamic measurement systems processes physiological data to assist in diagnosing urinary tract function. Given its diagnostic role, regulatory oversight ensures the software meets quality, safety, and performance standards before market entry. Compliance with CDSCO regulations not only ensures patient safety but also builds confidence among healthcare providers and end-users.
CDSCO Regulatory Framework for Software as a Medical Device (SaMD)
In India, software that qualifies as a medical device falls under the purview of the Central Drugs Standard Control Organization (CDSCO). The device you manufacture or import is classified as Class B, which means it poses a moderate risk and requires a manufacturing license from the State Licensing Authority via an MD5 license.
The relevant notification for this device is 29/Misc./03/2020-DC (198) dated 13th September 2021, which explicitly includes software medical devices under regulatory oversight.
Risk Classification and License Requirements for Class B Software
Class B devices like your software require an MD5 license (Manufacturing License for Class A and B medical devices). The MD5 license process involves:
- Obtaining a Test License (Form MD13) first
- Product testing from CDSCO-approved laboratories
- Compilation and submission of detailed documents, including Device Master File and Plant Master File
- Audit by a notified body
- Resolution of any regulatory queries
The entire process typically takes 3 to 4 months to complete.
Manufacturing License Process (MD5) for Class B Software
Apply for Test License (Form MD13): Initiate your application for a test license on the CDSCO MD Online Portal. The test license is valid for 1.5 to 2 months and allows you to submit your software for mandatory testing.
Product Testing: Your software must undergo performance and safety testing at CDSCO-approved labs. Refer to the official list of testing laboratories for accredited facilities.
Document Preparation: Compile all necessary documents as per CDSCO requirements, including technical files, quality management system documentation, and evidence of compliance with essential principles.
Submit License Application (Form MD3): After successful testing, apply for the manufacturing license (MD5) using Form MD3 on the MD Online Portal.
Audit by Notified Body: A notified body from the CDSCO list will audit your manufacturing premises and quality systems.
Query Resolution and License Grant: Address any queries from the regulatory department or notified body promptly. Upon satisfactory resolution, the MD5 license will be granted.
Manufacturing License Documents Required
For your software urodynamic measurement system, prepare the following key documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Technical Staff Qualifications and Experience Records
- Fire NOC and Pollution Control Clearance
- Device Master File (DMF): Detailed software design, development, validation, and maintenance processes (Learn more about DMFs)
- Plant Master File (PMF): Manufacturing processes, quality control, and facility description (Guide to PMF)
- Essential Principles Compliance Checklist
- Risk Management File detailing software risk analysis and mitigation (Implement Risk Management)
- Test Reports from approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process (MD15) for Software Devices
If you plan to import this software, the import license (MD15) is granted by the Central Licensing Authority. Import licenses take approximately 5 to 6 months.
Key steps include:
- Preparing comprehensive documentation including existing manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files
- Applying via Form MD14 on the CDSCO MD Online Portal
- Responding to regulatory queries
- Receiving the MD15 import license
The MD15 license process does not require a test license.
Import License Documents Required
- Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for import
- Company Constitution and Incorporation documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Compilation | 2 – 3 weeks |
| Application Submission (MD5) | Immediate after docs |
| Audit and Query Resolution | 4 – 6 weeks |
| Total for MD5 License | 3 to 4 months |
For import licenses (MD15), expect approximately 5 to 6 months overall.
Government Fees and Costs
For your Class B software device, the fee structure is as follows:
- Test License (MD13): No separate fees stated but included in overall process
- MD5 Manufacturing License:
- Rs. 5,000 per application
- Rs. 500 per product
Additional costs may include:
- Testing lab fees (varies by lab and scope)
- Notified body audit fees
- Consultancy or legal support fees if engaged
Common Challenges and Practical Solutions
Challenge: Delay in obtaining test reports from approved labs.
Solution: Engage with labs early and confirm timelines. Choose labs familiar with software testing for medical devices.
Challenge: Non-compliance with Quality Management System (QMS) requirements.
Solution: Implement and maintain ISO 13485:2016 QMS, focusing on software lifecycle documentation.
Challenge: Queries related to Device Master File completeness.
Solution: Prepare comprehensive technical files covering software development lifecycle, validation, risk management, and maintenance.
Challenge: Audit non-conformities.
Solution: Conduct internal audits prior to notified body inspections to ensure compliance.
Expert Consultation and Support
Navigating CDSCO licensing for medical device software can be complex. With our extensive experience assisting over 500 companies, we provide tailored support to streamline your application, including:
- Gap analysis of your current documentation
- Preparation of Device and Plant Master Files
- Risk management strategy development
- Coordinating with notified bodies and testing labs
- End-to-end application management on the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
Step 1: Confirm your device classification and regulatory pathway by reviewing the official CDSCO classification notification or our detailed Medical Device Classification guide.
Step 2: Register your organization on the CDSCO MD Online Portal and initiate the test license application (Form MD13).
Step 3: Identify and engage a CDSCO-approved testing laboratory early to schedule your software testing.
Step 4: Begin compiling your Device Master File and Plant Master File. Utilize our comprehensive guides on Device Master Files and Plant Master Files.
Step 5: Prepare your Quality Management System documentation aligned with ISO 13485:2016 and ensure robust risk management processes.
Step 6: Upon receiving test reports, submit your MD5 license application (Form MD3) and prepare for the notified body audit.
Step 7: Address audit findings and regulatory queries swiftly to ensure timely license grant.
Embarking on this process with expert guidance can significantly reduce delays and improve the chances of a successful, first-time approval. Contact us today to leverage our proven expertise in CDSCO licensing for Class B medical device software.
By following this detailed, step-by-step approach tailored specifically for software urodynamic measurement systems, manufacturers and importers can confidently navigate the Indian regulatory landscape and bring their innovative solutions to market.
