CDSCO License for Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use

Comprehensive Guide to CDSCO Licensing for Electrohydraulic/Pneumatic Lithotripsy System Probe, Urinary, Single-Use

As a device designed for urological applications, the Electrohydraulic/Pneumatic Lithotripsy System Probe (single-use) plays a crucial role in the non-invasive fragmentation of urinary tract calculi. Classified as a Class B medical device under CDSCO regulations, obtaining the correct license is essential for legal manufacturing and marketing in India. With over 25 years of experience and having supported 500+ companies through the CDSCO licensing process, we provide you with detailed, practical guidance tailored specifically to this device.

Understanding the Device and Regulatory Importance

This single-use, sterile lithotripsy probe transmits shock waves from electrohydraulic or pneumatic sources directly to urinary calculi, facilitating efficient in situ fragmentation. Due to its direct contact with internal tissues and its critical role in patient safety, regulatory compliance is paramount. The Central Drugs Standard Control Organization (CDSCO) mandates stringent evaluation to ensure safety, efficacy, and quality before market entry.

CDSCO Regulatory Framework for Electrohydraulic/Pneumatic Lithotripsy Probes

The regulatory framework is based on risk classification and intended use. As a Class B device, the probe falls under the moderate risk category, necessitating a manufacturing license from the State Licensing Authority through the MD5 licensing pathway. The relevant notification for this device is File No. 29/Misc./03/2020-DC (145), dated 23.8.2021.

Risk Classification and License Requirements

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

Class B devices require compliance with prescribed standards, testing, and audits conducted by notified bodies, ensuring adherence to quality and safety norms.

Manufacturing License Process for Electrohydraulic/Pneumatic Lithotripsy System Probe (MD5)

The MD5 licensing process typically spans 3 to 4 months and involves the following stages:

1. Test License Acquisition (Form MD13): Initial step to allow sample testing; processing takes approximately 1.5 to 2 months.
2. Product Testing: Conducted at government-approved testing laboratories to verify compliance with Indian standards. Refer to the list of testing laboratories for accredited labs.
3. Document Preparation: Comprehensive compilation of technical and quality documentation.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: An on-site audit according to notified body guidelines. Check the list of notified bodies for suitable auditors.
6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body.
7. Grant of License (Form MD5): Upon satisfactory compliance, the manufacturing license is issued.

Manufacturing License Documents Required

For a Class B device such as this lithotripsy probe, prepare the following documentation:

• Company Constitution and Incorporation Documents: Proof of legal entity.
• Proof of Ownership or Lease of Manufacturing Premises: To establish site control.
• Technical Staff Qualification and Experience Certificates: To demonstrate competent personnel.
• No Objection Certificates (NOC): Fire safety and pollution control clearances.
• Device Master File (DMF): Detailed device specifications, design, and manufacturing processes. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Description of manufacturing facilities and quality systems. Refer to our Plant Master File guide.
• Essential Principles Checklist: Compliance with Indian regulatory requirements.
• Risk Management File: Demonstrating identified risks and mitigation strategies, aligned with ISO 14971. Learn more about implementing risk management.
• Product Test Reports: From government-approved laboratories.
• Labels and Instructions for Use (IFU): In compliance with CDSCO labeling standards.
• Quality Management System (QMS) Documents: Proof of ISO 13485 certification and internal quality procedures.

Import License Process (MD15) for Electrohydraulic/Pneumatic Lithotripsy Probes

For companies importing this device into India, an Import License (MD15) issued by the Central Licensing Authority is mandatory. The process generally takes 5 to 6 months and includes:

• Document preparation including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
• Submission of application via the CDSCO MD Online Portal.
• Queries resolution and final license grant.

The detailed import license guide can be found here.

Import License Documents Required

• Valid Manufacturing License from the exporting country
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate
• Device Master File
• Plant Master File
• Wholesale License for India
• Company Constitution

Timeline and Processing Duration

Total Time: Approximately 3 to 4 months for manufacturing license (MD5) for Class B devices.

Government Fees and Costs

• Test License (MD13): Minimal, included in the overall process.
• MD5 Application Fee: ₹5,000 per application.
• Per Product Fee: ₹500 per product.
• Testing and Audit Costs: Variable depending on notified body and testing lab fees; budget approximately ₹1,00,000 to ₹2,00,000 for comprehensive testing and audits.

Common Challenges and Solutions

• Delayed Testing Reports: Partner with accredited labs early to schedule testing and minimize delays.
• Incomplete Documentation: Utilize checklists and expert consultation to ensure completeness.
• Audit Non-Compliance: Prepare thoroughly with internal pre-audits and address previous observations.
• Query Resolution Delays: Assign dedicated regulatory personnel to monitor and respond promptly.

Expert Consultation and Support

Navigating CDSCO regulations demands precision and experience. We provide hands-on support at every step—from documentation to audit readiness—ensuring your Electrohydraulic/Pneumatic Lithotripsy System Probe gains timely approval. Our proven track record with over 500 medical device companies guarantees you receive practical, actionable advice tailored to your unique challenges.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class B status and eligibility for MD5 licensing.
2. Gather Initial Documentation: Begin compiling company documents, technical files, and facility information.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate testing.
4. Select Testing Laboratory and Notified Body: Choose from government-approved entities to conduct product testing and audits.
5. Prepare Device and Plant Master Files: Use our detailed guides to create compliant files.
6. Plan for Audit: Conduct internal audits and ensure quality systems meet requirements.
7. Submit Manufacturing License Application: Apply using Form MD3 on the online portal.
8. Respond to Queries Promptly: Maintain open communication with CDSCO officials.

Embarking on this journey with expert guidance streamlines your path to market entry. Contact us to leverage our deep expertise and ensure a smooth licensing process for your Electrohydraulic/Pneumatic Lithotripsy System Probe.

For further information on device classification, visit our Medical Device Classification resource.