CDSCO License for Intracorporeal lithotripsy suction system
Medical Device Information
Intended Use
An assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy.
Comprehensive Guide to CDSCO Licensing for Intracorporeal Lithotripsy Suction System (Class B Medical Device)
Introduction: Understanding Your Intracorporeal Lithotripsy Suction System and Regulatory Importance
The Intracorporeal Lithotripsy Suction System is a specialized medical device designed to work alongside intracorporeal lithotripsy to efficiently evacuate irrigation fluid and urinary stone fragments from the kidneys, ureters, and bladder. Classified under urology devices, this assembly plays a critical role in minimally invasive procedures for urinary calculi management.
Given its direct contact with body fluids and involvement in surgical procedures, regulatory compliance with the Central Drugs Standard Control Organisation (CDSCO) is mandatory before manufacturing or importing this Class B device in India. Navigating the CDSCO licensing framework ensures patient safety, legal compliance, and smooth market entry.
CDSCO Regulatory Framework for the Intracorporeal Lithotripsy Suction System
The CDSCO regulates medical devices based on risk classification, with Class B devices like the Intracorporeal Lithotripsy Suction System categorized as low to moderate risk. The regulatory framework for such devices involves obtaining a manufacturing license (MD5) or import license (MD15) depending on your business model.
The relevant notification governing this device is File No. 29/Misc./03/2020-DC (145), dated 23.8.2021, which officially classifies and governs compliance requirements.
Risk Classification and License Requirements for Class B Devices
Class B devices require a manufacturing license under Form MD3 (MD5 License) issued by the State Licensing Authority. This process involves:
- Obtaining a Test License (Form MD13) initially
- Product testing in government-approved labs
- Document submission and audit by a Notified Body
For detailed classification insights, refer to our Medical Device Classification guide.
Manufacturing License Process for Intracorporeal Lithotripsy Suction System (MD5 License)
Our extensive experience assisting over 500 companies confirms that the MD5 license process for Class B devices spans approximately 3 to 4 months. The critical steps include:
Apply for Test License (MD13): This preliminary license is essential to conduct product testing and typically takes 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved laboratories. You can find the list of testing laboratories here.
Documentation Preparation: Assemble comprehensive documents including Device Master File, Plant Master File, and Risk Management File.
Apply for MD5 License (Form MD3): Submit the application via the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit is conducted by a notified body to verify compliance. Check the list of notified bodies.
Query Resolution: Address any queries from the CDSCO or notified body promptly to avoid delays.
Grant of License: Upon successful audit and document approval, the license is granted on Form MD5.
Manufacturing License Documents Required
Manufacturers must submit the following documents for the MD5 license:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of ownership or lease agreement of manufacturing premises
- Qualification and experience details of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design and manufacturing processes (DMF Guide)
- Plant Master File (PMF): Details of manufacturing facilities (PMF Guide)
- Essential Principles Checklist verifying compliance with Indian regulations
- Risk Management File documenting hazard analyses and mitigation (Risk Management Guide)
- Product Test Reports from CDSCO-approved labs
- Labels, Instructions for Use (IFU), and packaging details
- Quality Management System (QMS) documents, usually ISO 13485 certified
Import License Process for Intracorporeal Lithotripsy Suction System (MD15 License)
For importers, the MD15 license is mandatory and granted by the Central Licensing Authority. The process takes approximately 5 to 6 months and involves:
- Comprehensive document preparation including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, and ISO 13485:2016 certification
- Submission of application on the CDSCO MD Online Portal
- Review and query resolution by CDSCO
- Grant of MD15 license
Unlike manufacturing, the import process does not require a test license but demands more stringent documentation.
Import License Documents Required
Key documents for MD15 application include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Quality Management System certification
- CE Certificate for device conformity
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution and address proof
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Documentation Preparation | 2 to 3 weeks |
| MD5 Application & Audit | 1.5 to 2 months |
| Total Manufacturing License | Approx 3 to 4 months |
For import licenses (MD15), expect 5 to 6 months total processing time.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B) | Rs. 5,000 | Rs. 500 |
Note: Fees are payable online during application submission.
Additional costs include notified body audit charges (vary by body), testing fees at government labs, and preparation of technical documents. Budgeting for approximately Rs. 1,00,000 to Rs. 2,00,000 for end-to-end compliance is prudent.
Common Challenges and Solutions
1. Delays in Test License Grant: Often caused by incomplete documentation or lack of clarity in device description. Solution: Prepare detailed and precise application dossiers and engage consultants if needed.
2. Product Testing Failures: Non-compliance with Indian standards can cause repeated testing delays. Solution: Pre-validate product specifications and conduct internal quality audits.
3. Audit Non-Compliance: Missing QMS elements or plant deficiencies may lead to audit failures. Solution: Ensure ISO 13485 certification and readiness for notified body audits.
4. Query Resolution Delays: Slow responses to CDSCO queries elongate timelines. Solution: Maintain a dedicated regulatory liaison team for immediate attention.
Expert Consultation and Support
With over 25 years of regulatory consulting experience and over 500 successful CDSCO license applications, we provide end-to-end support including:
- Gap analysis and readiness assessment
- Document preparation and review
- Liaison with CDSCO officials and notified bodies
- Mock audits and training
Our proven track record ensures faster approvals and mitigates costly delays.
Getting Started with Your CDSCO License Application
To initiate your license process for the Intracorporeal Lithotripsy Suction System:
Assess your device classification and confirm required license type. For this Class B device, plan for an MD5 manufacturing license.
Gather all mandatory documents listed above. Leverage our Device Master File guide and Plant Master File guide to streamline documentation.
Apply for the Test License (Form MD13) on the CDSCO MD Online Portal.
Coordinate with CDSCO-approved labs for product testing.
Schedule your notified body audit early to align with your license application timeline.
Submit the MD5 license application (Form MD3) online, monitor the application status, and respond promptly to any queries.
Starting early and engaging expert consultants can significantly ease the process. Contact us today to leverage our expertise for a seamless CDSCO licensing journey.
This detailed roadmap is tailored specifically for manufacturers and importers of the Intracorporeal Lithotripsy Suction System seeking compliance with Indian medical device regulations. Our insights ensure you meet all regulatory expectations while minimizing risks and delays.
