CDSCO License for Electromechanical lithotripsy system, intracorporeal

Comprehensive Guide to CDSCO Licensing for Electromechanical Lithotripsy System (Intracorporeal) – Class B Medical Device

As a trusted regulatory consultancy with over 25 years of experience and having supported more than 500 companies in navigating the Indian medical device approval landscape, we understand the intricacies involved in obtaining a CDSCO manufacturing or import license. This guide focuses specifically on the Electromechanical Lithotripsy System, Intracorporeal, a Class B urology device, designed to fragment urinary tract calculi via electromechanical shock waves.

Introduction: Device Overview and Regulatory Importance

The Electromechanical Lithotripsy System is a sophisticated assembly intended for intracorporeal fragmentation of kidney, ureter, and bladder stones. As a Class B device, it poses a moderate risk and thus requires compliance with CDSCO’s manufacturing license framework. Given its critical role in urological procedures, ensuring regulatory compliance is not only a legal mandate but a commitment to patient safety and product efficacy.

CDSCO Regulatory Framework for Electromechanical Lithotripsy System

Regulation of medical devices in India falls under the purview of the Central Drugs Standard Control Organization (CDSCO). For Class B devices like the Electromechanical Lithotripsy System, the MD5 license, granted by the State Licensing Authority, governs manufacturing permissions.

This process ensures manufacturers meet quality standards, including adherence to Good Manufacturing Practices (GMP), and that devices conform to applicable safety and performance requirements.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk)
• Applicable License: MD5 (Manufacturing License under Form MD3)
• Regulatory Authority: State Licensing Authority

You can verify device classification and regulatory requirements through our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

Obtaining an MD5 license for your Electromechanical Lithotripsy System involves a multi-step process:

1. Test License Application (Form MD13): Initiates product testing; duration approx 1.5–2 months.
2. Product Testing: Mandatory testing at government-approved labs for safety and performance.
3. Document Preparation: Compilation of technical, quality, and compliance documents.
4. License Application (Form MD3): Submission of manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: On-site audit by an approved notified body. Find the list of notified bodies here.
6. Queries and Resolution: Address any issues raised during audit or by CDSCO.
7. Grant of License (Form MD5): Upon successful completion, the license is granted.

Manufacturing License Documents Required

To streamline your application, ensure the following documents are complete and up-to-date:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff with Qualifications and Experience
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF): Detailed device design and manufacturing information (Device Master File Guide)
• Plant Master File (PMF): Manufacturing facility details (Plant Master File Guide)
• Essential Principles Checklist (Compliance with Indian Medical Device Rules)
• Risk Management File (per ISO 14971 standards) (Risk Management Guide)
• Test Reports from Government Approved Laboratories (Testing Laboratories List)
• Product Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 Certification

Import License Process (MD15) for Electromechanical Lithotripsy Systems

If you plan to import this device into India, the MD15 license granted by the Central Licensing Authority applies. The process typically takes 5-6 months and requires:

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Application is submitted on the CDSCO MD Online Portal using Form MD14.

Timeline and Processing Duration

For your Electromechanical Lithotripsy System (Class B):

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (can overlap with document prep)
• Document Preparation: 2 to 3 weeks (if well-organized)
• License Application & Audit: 1 to 2 months
• Total: Approximately 3 to 4 months from start to finish

Government Fees and Costs

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Note: Delays in audit readiness or incomplete documentation can increase total costs indirectly by extending the timeline.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Pre-select government-approved testing labs and schedule tests early. Maintain clear communication with labs.

Challenge 2: Incomplete Documentation

• Solution: Use checklists and templates for DMF, PMF, Risk Management Files, and Quality Systems. Engage experienced consultants to review before submission.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal audits and gap analysis based on notified body criteria. Prepare your technical and quality teams for onsite inspections.

Challenge 4: Resolving CDSCO Queries

• Solution: Respond promptly and comprehensively with supporting evidence. Keep a dedicated regulatory liaison for efficient communication.

Expert Consultation and Support

Our regulatory experts have facilitated successful CDSCO licenses for over 500 medical device manufacturers and importers. We offer:

• End-to-end application management
• Document preparation and review
• Pre-audit readiness assessments
• Liaison with notified bodies and CDSCO officials

Learn more about our MD5 licensing services in our MD5 License Guide.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class B.
2. Prepare Technical Documentation: Develop or update your Device and Plant Master Files.
3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal, initiating product testing.
4. Schedule Product Testing: Coordinate with notified government testing labs.
5. Compile Complete License Application: Gather all required documents, including QMS certificates and NOCs.
6. Engage Notified Body for Audit: Select from the list of notified bodies for your onsite audit.
7. Submit Application for MD5: File the application through the online portal and monitor progress regularly.

Starting early and engaging experienced regulatory professionals can significantly ease the process and ensure timely market access for your Electromechanical Lithotripsy System. Contact us to leverage our expertise and accelerate your CDSCO licensing journey.