CDSCO License for Automated peritoneal dialysis system
Medical Device Information
Intended Use
An active medical devices intended to perform peritoneal dialysis.
Comprehensive Guide to CDSCO Licensing for Automated Peritoneal Dialysis Systems (Class C Medical Device)
Automated Peritoneal Dialysis Systems are critical active medical devices designed for nephrology and renal care, facilitating efficient peritoneal dialysis treatment. Due to their complexity and patient impact, these devices fall under Class C risk classification as per CDSCO regulations, requiring stringent regulatory compliance before market entry in India.
With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we provide you with a detailed roadmap for acquiring your manufacturing and import licenses for Automated Peritoneal Dialysis Systems, ensuring smooth regulatory approval and faster market access.
CDSCO Regulatory Framework for Automated Peritoneal Dialysis Systems
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India under the Medical Device Rules, 2017. Automated Peritoneal Dialysis Systems, notified under 29/Misc./03/2020-DC (143) dated 13.9.2021, are active medical devices that require compliance with the essential principles of safety and performance.
As a Class C device, these systems are considered moderate to high risk, requiring central licensing authority approval for manufacturing and import.
Risk Classification and License Requirements
- Risk Class: C
- Regulatory Authority: Central Licensing Authority (CDSCO, New Delhi)
- Manufacturing License: MD9 (Form MD7)
- Import License: MD15 (Form MD14)
- Applicable Notifications: 29/Misc./03/2020-DC (143) dated 13.9.2021
For Class C medical devices like Automated Peritoneal Dialysis Systems, the manufacturing license is issued by the central licensing authority after successful testing, audit, and compliance verification.
Manufacturing License Process for Class C Devices (MD9 License)
Obtaining an MD9 manufacturing license involves several critical steps, generally spanning 4-5 months:
- Test License Application (Form MD13): Initiate by applying for a test license, valid for 6 months, allowing product testing in CDSCO-approved laboratories.
- Product Testing: Conduct mandatory safety and performance tests at government-approved labs listed on the CDSCO Testing Laboratories portal.
- Document Preparation: Compile Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and other required documents.
- Submission of Manufacturing License Application (Form MD7) via the CDSCO MD Online Portal:
- CDSCO Inspection and Audit: CDSCO inspectors audit your manufacturing premises for GMP compliance.
- Resolution of Queries: Promptly address any queries raised by CDSCO during the review.
- Grant of MD9 License (Form MD9): Upon satisfaction, CDSCO issues the manufacturing license.
Practical Tip:
Engage with a notified body early in the process for pre-audit consultation. Refer to the list of notified bodies authorized for Class C device audits.
Manufacturing License Documents Required
For the MD9 license, prepare the following key documents:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of ownership or lease of manufacturing premises
- Qualification and experience certificates of technical staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (DMF Guide)
- Plant Master File (PMF) showcasing facility layout and quality systems (PMF Guide)
- Essential Principles Checklist ensuring compliance with safety and performance standards
- Risk Management File demonstrating a robust risk analysis and mitigation strategy (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Product labels and Instructions for Use (IFU) compliant with Indian regulations
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certified
Import License Process for Automated Peritoneal Dialysis Systems (MD15 License)
Importers must obtain an MD15 license from CDSCO’s central authority. The process generally takes 5-6 months and includes:
- Document Preparation: Gather necessary documents including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device and Plant Master Files, Wholesale Drug License, and Company Constitution.
- Application Submission: File the application using Form MD14 through the CDSCO MD Online Portal.
- Review and Query Resolution: CDSCO reviews your application and communicates any clarifications.
- Grant of Import License (Form MD15): After satisfying all requirements, CDSCO issues the import license.
Important:
Test licenses are not required for import applications, but compliance with all documentation and certifications is critical.
Import License Documents Required
- Manufacturing License issued by the regulatory authority of the exporting country
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent certification
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and incorporation documents
- Product labels and IFU compliant with CDSCO regulations
Timeline and Processing Duration
| License Type | Processing Authority | Approximate Duration | Notes |
|---|---|---|---|
| MD9 Manufacturing | Central Licensing Authority | 4-5 months | Includes test license phase |
| MD15 Import | Central Licensing Authority | 5-6 months | No test license required |
Real-world experience indicates that early and complete document submission can reduce follow-up queries and accelerate approvals.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee | Total Cost Example for 3 Products |
|---|---|---|---|
| MD9 Manufacturing | Rs 50,000 | Rs 1,000 | Rs 53,000 |
| MD15 Import | USD 3,000/site | USD 1,500/product | USD 7,500 (for 3 products) |
Fees must be paid online via the CDSCO portal. Budgeting accurately helps avoid delays.
Common Challenges and Solutions
- Incomplete Documentation: Frequently encountered; ensure all files like DMF, PMF, and Risk Management Files are comprehensive and updated.
- Delayed Test Reports: Partner only with CDSCO-approved labs to avoid re-testing or rejection.
- Audit Non-Compliance: Pre-audit readiness with expert consultants minimizes non-conformities.
- Query Backlogs: Assign dedicated regulatory personnel to respond promptly.
Expert Consultation and Support
Our consultancy leverages deep expertise to guide you through every step—document preparation, testing coordination, audit assistance, and follow-up with CDSCO. We have successfully facilitated MD9 and MD15 licenses for over 500 companies, specializing in nephrology devices.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class C using the Medical Device Classification resource.
- Register on CDSCO MD Online Portal: Create your account to submit applications smoothly.
- Initiate Test License Application: For manufacturing, begin with Form MD13.
- Engage Accredited Testing Labs: Coordinate product testing early to meet timelines.
- Prepare and Organize Key Documents: Utilize our Device Master File and Plant Master File guides.
- Schedule a Pre-Audit Consultation: Work with notified bodies for insights into compliance readiness.
Embarking on your CDSCO licensing journey with thorough preparation and expert guidance ensures timely approval and successful market entry for your Automated Peritoneal Dialysis System in India. Reach out to our regulatory consultants today to kick-start your application process.
