CDSCO License for Ultrasonic lithotripsy system
Medical Device Information
Intended Use
An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder.
Comprehensive Guide to CDSCO Licensing for Ultrasonic Lithotripsy Systems (Class B)
As a medical device regulatory consultancy with over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we understand the nuances and critical importance of timely compliance. In this guide, we focus on the Ultrasonic Lithotripsy System—a Class B urology device used for the intracorporeal fragmentation of stones in the kidney, ureter, and bladder. This device, notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, requires precise adherence to CDSCO regulations for successful market entry in India.
Understanding the CDSCO Regulatory Framework for Ultrasonic Lithotripsy Systems
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Since the Ultrasonic Lithotripsy System falls under Class B (low-moderate risk), the regulatory pathway mandates obtaining an MD5 manufacturing license for domestic production or an MD15 import license for overseas manufacturers or importers.
Risk Classification and License Requirements for Ultrasonic Lithotripsy Systems
According to the Medical Device Classification, Class B devices like ultrasonic lithotripsy systems require:
- Manufacturing License: MD5 License (Form MD3) issued by the State Licensing Authority
- Import License: MD15 License (Form MD14) issued by the Central Licensing Authority
This classification dictates the documentation, testing, audit, and fees applicable.
Step-by-Step Manufacturing License Process (MD5) for Ultrasonic Lithotripsy Systems
- Apply for Test License (Form MD13): Before the full manufacturing license, obtain a test license which takes about 1.5 to 2 months. This allows initial product testing.
- Product Testing: Get the ultrasonic lithotripsy system tested at a CDSCO-approved testing laboratory. Refer to the Testing Laboratories list for accredited facilities.
- Document Preparation: Compile all necessary documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
- Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: Engage with a notified body for the mandatory audit. Check the list of notified bodies to select one.
- Query Resolution: Address any queries from CDSCO or the notified body promptly.
- License Grant: Post successful audit and compliance, the MD5 license is granted on Form MD5.
Essential Documents Required for MD5 License Application
- Company Constitution (e.g., MOA/AOA)
- Proof of Premises Ownership or Lease Agreement
- Qualification and Experience Certificates of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF) – comprehensive technical dossier (Device Master File Guide)
- Plant Master File (PMF) – manufacturing facility details (Plant Master File Guide)
- Essential Principles Checklist
- Risk Management File (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 compliance)
Import License Process (MD15) for Ultrasonic Lithotripsy Systems
For importers, the MD15 license application requires:
- Document Compilation: Unlike manufacturing, no test license is required. Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
- Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
- Queries Resolution: Promptly respond to any departmental queries.
- License Grant: After review, CDSCO issues the MD15 Import License.
Documents Required for MD15 Import License
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution Documents
Timelines and Processing Durations
| License Type | Process Duration |
|---|---|
| MD5 Manufacturing | 3 to 4 months total |
| (Including Test License and Audit) | |
| MD15 Import | 5 to 6 months |
The test license phase for MD5 takes about 1.5–2 months, followed by testing, audit, and final approval.
Government Fees and Costs Breakdown
| License Type | Base Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B) | Rs 5,000 | Rs 500 |
| MD15 (Class B) | $2,000 (approx Rs 1.6 Lakh) | $1,000 (approx Rs 80,000) |
Manufacturers must budget for notified body audit fees and testing charges separately.
Common Challenges and Practical Solutions
- Delayed Testing: Lab backlogs can cause delays. Pre-book testing slots at CDSCO-approved labs early.
- Incomplete Documentation: Ensure thorough preparation of Device and Plant Master Files with cross-functional inputs.
- Audit Non-Compliance: Conduct internal audits and gap analyses before notified body visits.
- Query Responses: Designate a dedicated liaison to respond promptly to CDSCO queries to avoid unnecessary delays.
Expert Consultation and Support
With our extensive experience, we provide end-to-end support—from gap analysis, document preparation, audit facilitation to post-license compliance. Our team has successfully navigated regulatory complexities for over 500 medical device companies, including those manufacturing ultrasonic lithotripsy systems.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class B status using the Medical Device Classification tool.
- Engage a Notified Body Early: Select an appropriate notified body from the official list.
- Initiate Test License Application: For manufacturers, apply for Form MD13 via the CDSCO MD Online Portal.
- Prepare Documentation: Start compiling your Device Master File and Plant Master File.
- Schedule Product Testing: Coordinate with CDSCO-approved labs to test your ultrasonic lithotripsy system.
- Plan for Audit: Conduct internal audits to ensure compliance before the notified body visit.
- Submit Final License Application: Complete and upload Form MD3 for MD5 license or Form MD14 for MD15 import license.
Navigating CDSCO licensing for Class B devices like the Ultrasonic Lithotripsy System requires precision and timely action. Partnering with experienced consultants can streamline the process, reduce risks of rejection, and expedite market access. Contact us to leverage our deep regulatory expertise and get your device approved efficiently.
For more detailed insights, explore our guides on MD5 License, MD15 Import License, and Risk Management.
