CDSCO License for Peritoneal dialysis system dialysate filter
Medical Device Information
Intended Use
A microporous device used to capture contamination particles of the dialysate before its instillation into the peritoneal cavity.
Comprehensive Guide to CDSCO Licensing for Peritoneal Dialysis System Dialysate Filter (Class C Medical Device)
Manufacturers and importers of the Peritoneal Dialysis System Dialysate Filter, a Class C medical device used in nephrology and renal care, must navigate the rigorous regulatory framework established by the Central Drugs Standard Control Organization (CDSCO) for market entry in India. This microporous device plays a critical role in patient safety by filtering contamination particles from dialysate prior to peritoneal cavity instillation, making compliance with CDSCO regulations imperative.
CDSCO Regulatory Framework for Peritoneal Dialysis System Dialysate Filter
India classifies medical devices into risk classes A, B, C, and D. Peritoneal dialysis system dialysate filters fall under Class C due to their invasive nature and significant impact on patient health. The CDSCO mandates that all Class C devices obtain a manufacturing license (MD9) granted by the Central Licensing Authority. This regulatory oversight ensures that the device meets essential safety, quality, and performance standards as per the notification 29/Misc./03/2020-DC (143).
Risk Classification and License Requirements
- Device Risk Class: Class C
- Regulatory Authority: Central Licensing Authority (CDSCO HQ)
- License Type: MD9 Manufacturing License (Form MD7)
- Applicable Notification: 29/Misc./03/2020-DC (143), dated 13.9.2021
Class C devices like the peritoneal dialysis dialysate filter require stringent testing, documentation, and audit processes before license issuance. Obtaining the MD9 license is a multi-step process that ensures compliance with Indian regulatory standards.
Manufacturing License Process (MD9)
The MD9 license process for Class C devices includes:
- Test License Application (Form MD13): Initially, manufacturers must apply for a test license to legally produce samples for testing. This phase typically takes 1.5 to 2 months.
- Product Testing: Samples must be evaluated by CDSCO-approved testing laboratories. Refer to the Testing Laboratories list for authorized facilities.
- Document Preparation: Comprehensive documentation must be prepared, including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality system documents.
- License Application (Form MD7): Submit the MD9 license application via the CDSCO MD Online Portal.
- Inspection & Audit: CDSCO inspectors conduct a detailed audit of manufacturing facilities and quality management systems.
- Query Resolution: Respond promptly to any queries raised by CDSCO during evaluation.
- License Grant: Upon satisfactory review, the MD9 manufacturing license is granted on Form MD9.
The entire process generally spans 4 to 5 months, depending on the preparedness of documents and promptness in addressing queries.
Manufacturing License Documents Required
For the peritoneal dialysis system dialysate filter, manufacturers must submit the following:
- Company Constitution documents (e.g., incorporation certificate)
- Proof of ownership or lease agreement for manufacturing premises
- Technical staff qualifications and experience certificates
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed device specifications and design controls (Guide to Device Master Files)
- Plant Master File (PMF): Manufacturing site details and quality systems (PMF Guide)
- Essential Principles Checklist demonstrating compliance with Indian standards
- Risk Management File detailing hazard analysis and mitigation (Risk Management Practices)
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Ensuring accuracy and completeness in these documents reduces back-and-forth with regulators.
Import License Process (MD15)
If you are an importer aiming to bring the peritoneal dialysis system dialysate filter into India, the MD15 import license is mandatory. This license is issued by the Central Licensing Authority and involves:
- Document preparation, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, and CE certification
- Submission of application on Form MD14 through the CDSCO MD Online Portal
- Resolution of any queries raised
- Grant of license on Form MD15
The import license process typically takes 5 to 6 months.
Import License Documents Required
- Valid manufacturing license of the device in the country of origin
- Free Sale Certificate issued by the foreign regulatory authority
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File & Plant Master File
- Wholesale License in India (if applicable)
- Company Constitution
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| MD9 License Application | 1 - 1.5 months |
| Inspection & Audit | Included above |
| Query Resolution | Variable |
| Total Time (MD9 License) | 4 to 5 months |
| Import License (MD15) | 5 to 6 months |
Government Fees and Costs
- MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
- Test License (MD13): Usually ₹10,000 (varies by state)
- Import License (MD15):
- Class C Device Fee: $3,000 per site
- $1,500 per product
Budgeting for these fees upfront helps avoid delays.
Common Challenges and Solutions
- Incomplete Documentation: Many applicants face rejections due to missing Device Master Files or inadequate risk management reports. We recommend using standardized templates and cross-checking against the Essential Principles Checklist.
- Delays in Testing: Testing backlogs at CDSCO-approved labs can cause delays. Engage early with testing labs from the Testing Laboratories list to schedule tests.
- Audit Non-Compliance: Prepare thoroughly for CDSCO audits by conducting internal mock audits and ensuring QMS compliance.
- Regulatory Updates: Stay updated on notifications like 29/Misc./03/2020-DC (143) that impact device classification and licensing.
Expert Consultation and Support
With over 25 years of experience and more than 500 successful CDSCO license approvals, we provide end-to-end support:
- Preparing robust Device and Plant Master Files
- Coordinating with notified bodies and testing laboratories
- Managing application submissions and audit readiness
- Providing regulatory intelligence and compliance strategy
Our expert consultants ensure your peritoneal dialysis system dialysate filter meets all regulatory requirements efficiently.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device is Class C using the Medical Device Classification tool.
- Prepare Documentation: Begin compiling your DMF, PMF, risk management files, and QMS documents.
- Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
- Engage Testing Labs: Coordinate sample testing at CDSCO-approved facilities.
- Submit MD9 License Application: Upon successful testing, apply via the portal.
- Prepare for Audit: Conduct internal audits and training to ensure compliance.
- Resolve Queries Promptly: Respond to CDSCO queries within stipulated timelines.
Starting early and following a structured approach will streamline your licensing journey, enabling timely market entry and compliance assurance.
For tailored assistance and to leverage our extensive regulatory expertise, contact us today and take the first step towards obtaining your CDSCO MD9 manufacturing license for your peritoneal dialysis system dialysate filter.
