CDSCO License for Software for peritoneal dialysis treatment
Medical Device Information
Intended Use
A software that performs prescription simulation of peritoneal dialysis based on the results obtained from a peritoneal function test (PFT), a peritoneal equilibration test (PET) and a body composition analyzer. It supports preparation of a dialysis treatment plan.
Comprehensive Guide to CDSCO Licensing for Software Used in Peritoneal Dialysis Treatment (Class C Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having guided more than 500 companies through the CDSCO licensing maze, we understand the nuances involved in getting your software for peritoneal dialysis treatment approved in India. This specialized software performs prescription simulations based on peritoneal function tests (PFT), peritoneal equilibration tests (PET), and body composition analysis to aid clinicians in creating optimal dialysis treatment plans.
Given its critical role, the Central Drugs Standard Control Organization (CDSCO) classifies this software as a Class C medical device under notification 29/Misc./03/2020-DC (198) dated 13.9.2021. This mandates a stringent regulatory pathway, including obtaining an MD9 manufacturing license.
CDSCO Regulatory Framework for Peritoneal Dialysis Treatment Software
Software as a Medical Device (SaMD) has specific regulatory requirements in India. CDSCO governs such devices through the Medical Device Rules, 2017, and associated notifications. The software in question facilitates dialysis prescription simulation, impacting treatment decisions, hence its Class C risk classification.
You must comply with:
- Quality Management System (QMS) standards such as ISO 13485:2016
- Essential principles of safety and performance
- Risk management standards per ISO 14971
- Clinical evaluation and validation of software functions
For comprehensive classification details, refer to our Medical Device Classification guide.
Risk Classification and License Requirements
This peritoneal dialysis software is Class C, which means it poses moderate to high risk to patients if malfunctioning. Consequently, CDSCO mandates an MD9 manufacturing license granted by the Central Licensing Authority.
License Specifics for Class C Devices:
| License Type | Authority | Application Form | Timeline | Fees |
|---|---|---|---|---|
| MD9 Manufacturing License | Central Licensing Authority | MD7 | 4-5 months | Rs. 50,000 + Rs. 1,000 per product |
The complete process involves obtaining a test license (MD13), product testing, document submission, CDSCO inspection, and final license grant.
Manufacturing License Process (MD9) for Class C Software
Test License (Form MD13): Initial step to legally manufacture and test your software. This takes approximately 1.5 to 2 months.
Product Testing: Testing is mandatory through CDSCO-approved laboratories to validate software safety and performance. For your software, testing typically includes functionality, cybersecurity, and data integrity assessments.
Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and clinical evidence.
Application Submission (Form MD7): Apply on the CDSCO MD Online Portal with all necessary documents.
Audit and Inspection: CDSCO inspectors conduct audits of your manufacturing facility and QMS to ensure compliance.
Query Resolution: Address any observations or queries raised by CDSCO promptly.
License Grant (Form MD9): Upon satisfactory compliance, the MD9 manufacturing license is issued.
For a detailed walkthrough, see our MD9 License Guide.
Manufacturing License Documents Required
For software devices like peritoneal dialysis treatment simulators, you need to prepare and submit the following:
- Company Constitution and Incorporation Certificates
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff (especially software engineers and quality personnel)
- Fire and Pollution NOCs
- Device Master File (DMF) – detailing software design, development, validation, and maintenance processes (Guide here)
- Plant Master File (PMF) – describing manufacturing environment and facilities (Guide here)
- Essential Principles Checklist confirming compliance with safety and performance
- Risk Management File adhering to ISO 14971 principles (Risk Management insights)
- Test Reports from CDSCO-recognized labs (List of Testing Laboratories)
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents including SOPs, CAPA, and design controls
Import License Process (MD15) for Class C Devices
If you plan to import this software into India, an MD15 import license is mandatory. This license is granted by the Central Licensing Authority and has its own set of criteria:
- Application Form: MD14
- No test license required prior to application
- Documents include existing manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.
The process takes around 5 to 6 months and fees are:
| Class | Site Fee | Product Fee |
|---|---|---|
| Class C & D | Rs. 3,00,000 | Rs. 1,50,000 per product |
Apply via the CDSCO MD Online Portal. For more, see our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5-2 months |
| Product Testing | 1-1.5 months |
| Document Preparation | 2-3 weeks |
| Application Review & Audit | 1-1.5 months |
| Query Resolution | 2-4 weeks |
| License Grant (MD9) | Total 4-5 months |
Planning and proactive document management can reduce delays significantly.
Government Fees and Costs
- MD9 License Application: Rs. 50,000
- Per Product Fee: Rs. 1,000
- Test License (MD13) Fees: Approximately Rs. 5,000
- Testing Costs: Varies, expect Rs. 50,000 to Rs. 1,00,000 depending on testing scope
- Audit Fees: Paid to notified bodies conducting audits (Find notified bodies here)
Budgeting for these costs upfront will aid smooth execution.
Common Challenges and Solutions
Challenge 1: Delays in product testing due to limited accredited labs.
Solution: Engage early with CDSCO-recognized testing labs listed on their portal to schedule testing slots in advance.
Challenge 2: Incomplete or inconsistent documentation, especially for software validation and risk management.
Solution: Utilize expert consultants to prepare the Device Master File and Risk Management File aligned with international standards.
Challenge 3: Audit non-compliance due to inadequate QMS or facility readiness.
Solution: Conduct pre-audit internal reviews and gap analyses to ensure all processes meet CDSCO expectations.
Challenge 4: Prolonged query resolution leading to license delays.
Solution: Respond comprehensively and promptly to all CDSCO queries, providing additional evidence or clarifications as needed.
Expert Consultation and Support
Navigating the regulatory landscape for Class C software devices is complex. Our extensive experience enables us to offer tailored support:
- Preparation of technical documentation and master files
- Liaison with CDSCO and notified bodies
- Scheduling and oversight of product testing
- Training your team on compliance and audit readiness
Partnering with consultants who understand the regulatory nuances can cut your time to market by months.
Getting Started with Your CDSCO License Application
Assess Classification: Confirm your software’s Class C status per CDSCO guidelines.
Initiate Test License (MD13): Prepare and submit your application on the CDSCO MD Online Portal to legally begin testing and manufacturing.
Engage Testing Labs: Contact CDSCO-approved labs early to plan and execute necessary testing.
Document Compilation: Start compiling your Device Master File and Plant Master File; ensure risk management and essential principles are well documented.
Plan QMS Implementation: Align your quality system with ISO 13485 requirements and prepare for audit.
Apply for MD9 License (Form MD7): Once testing and documentation are ready, submit your application for the manufacturing license.
Prepare for Audit: Conduct mock audits internally or with consultants before the official CDSCO inspection.
Respond to Queries: Maintain responsive communication channels to address CDSCO’s questions quickly.
License Issuance: Upon successful audit and document approval, receive your MD9 manufacturing license.
Our team is ready to assist you at every step to ensure your peritoneal dialysis software reaches Indian patients safely and compliantly. Reach out for a consultation to kickstart your CDSCO licensing journey today.
