CDSCO License for Hand pneumatic lithotripsy system, urinary
Medical Device Information
Intended Use
An assembly of devices, held by the operator, that uses pneumatically-created ballistic shock waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidneys, ureters, and bladder) for their removal.
Comprehensive Guide to CDSCO Licensing for Hand Pneumatic Lithotripsy System, Urinary (Class B Medical Device)
Introduction: Understanding the Hand Pneumatic Lithotripsy System and Its Regulatory Importance
The Hand Pneumatic Lithotripsy System, urinary, is a critical urology device designed to fragment urinary calculi using pneumatically-generated ballistic shock waves. As an operator-held assembly, it plays a vital role in minimally invasive stone removal procedures in the kidneys, ureters, and bladder. Given its significant clinical use and inherent risk profile, this device is classified as Class B under the Indian medical device regulations.
Compliance with the Central Drugs Standard Control Organization (CDSCO) licensing framework is mandatory before marketing or manufacturing such devices in India. Navigating the regulatory landscape ensures patient safety, product efficacy, and legal market access.
CDSCO Regulatory Framework for Hand Pneumatic Lithotripsy Systems
The CDSCO classifies medical devices based on risk, intended use, and complexity. The Hand Pneumatic Lithotripsy System falls under Class B, indicating a low-to-moderate risk profile. Consequently, the licensing process is governed by the State Licensing Authority through the MD5 license pathway.
This regulatory framework mandates strict adherence to quality management systems, product testing, and documentation standards to safeguard end-users and healthcare providers.
Risk Classification and License Requirements for Class B Devices
Class B devices like the Hand Pneumatic Lithotripsy System require an MD5 manufacturing license, which involves the following key steps:
- Obtaining a preliminary Test License (Form MD13) to facilitate product testing.
- Conducting product testing through CDSCO-recognized laboratories.
- Preparing comprehensive technical and quality documentation.
- Undergoing a factory audit by a notified body.
- Resolving any queries raised by the licensing authority.
- Final grant of MD5 license (Form MD5).
Our experience with over 500 companies has shown that understanding these steps and preparing meticulously significantly reduces delays.
Manufacturing License Process (MD5) for Hand Pneumatic Lithotripsy System
- Apply for Test License on Form MD13: This license permits initial product testing and takes approximately 1.5 to 2 months to process.
- Conduct Product Testing: Testing must be performed at a CDSCO-approved testing laboratory. You can find the list of approved testing laboratories here.
- Prepare Documentation: Compile all required documents, including the Device Master File (DMF) and Plant Master File (PMF).
- Apply for Manufacturing License on Form MD3: Submit the application via the CDSCO MD Online Portal.
- Factory Audit by Notified Body: The notified body will audit manufacturing facilities. Reference the list of notified bodies for audit arrangements.
- Resolve Queries: Address any observations raised during audit or technical review promptly.
- Grant of License: Upon satisfactory compliance, the State Licensing Authority will issue the MD5 license.
Manufacturing License Documents Required
For the Hand Pneumatic Lithotripsy System (Class B), the following documents are essential:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Details of Qualified Technical Staff (qualification and experience certificates)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) covering device specifications, design, and testing (learn more here)
- Plant Master File (PMF) detailing infrastructure and processes (detailed guide here)
- Essential Principles Checklist demonstrating compliance with Indian regulatory standards
- Risk Management File in accordance with ISO 14971 (risk management insights)
- Product Test Reports from government-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Ensuring completeness and accuracy at this stage is critical to avoid processing delays.
Import License Process (MD15) for Hand Pneumatic Lithotripsy System
If you are an importer of this device, the MD15 license issued by the Central Licensing Authority under CDSCO regulations is mandatory. The process includes:
- Compilation of import-related documentation.
- Submission of application on Form MD14 via the CDSCO MD Online Portal.
- Technical review and query resolution.
- Grant of Import License (Form MD15).
Unlike manufacturing, a test license is not required for import applications. However, product testing certificates from recognized bodies, ISO 13485:2016, CE certificates, Free Sale Certificates, and other supporting documents are mandatory.
Import License Documents Required
Key documents for the MD15 import license include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or Equivalent
- ISO 13485:2016 Certification
- CE Certificate or other relevant international approvals
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution Documents
The fees vary according to device class and number of products imported.
Timeline and Processing Duration
| License Type | Process Duration | Key Milestones |
|---|---|---|
| MD5 Manufacturing License | 3 to 4 months | Test license (1.5-2 months), audit, query resolution |
| MD15 Import License | 5 to 6 months | Document review, queries, final license grant |
Planning timelines realistically and preparing documents upfront can help you avoid common bottlenecks.
Government Fees and Costs
For Class B devices like the Hand Pneumatic Lithotripsy System, the fees are as follows:
MD5 Manufacturing License:
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
MD15 Import License:
- Application Fee: $2,000 per site
- Product Fee: $1,000 per product
Additional costs include testing fees charged by laboratories and audit fees by notified bodies. Budgeting for these expenses early ensures smooth financial planning.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with CDSCO-approved labs early and confirm testing capacity. Allocate 2-3 months buffer for retesting if required.
Challenge 2: Incomplete or Inadequate Documentation
- Solution: Use checklists and expert consultations to ensure all files, such as DMF and PMF, meet CDSCO expectations. Refer to our Device Master File guide for detailed insights.
Challenge 3: Audit Non-compliance
- Solution: Pre-audit your manufacturing facility against notified body standards. Maintaining a robust QMS and training staff on compliance reduces audit observations.
Challenge 4: Navigating Query Resolution
- Solution: Respond promptly and with comprehensive evidence to queries raised by CDSCO or notified bodies. This accelerates license grant.
Expert Consultation and Support
With over 25 years of regulatory consulting experience and having assisted 500+ companies, we offer tailored support for CDSCO licensing of the Hand Pneumatic Lithotripsy System. Our services include:
- Pre-assessment of product classification and applicable regulations
- Documentation preparation and review
- Coordination with testing laboratories and notified bodies
- Application submission and follow-up via the CDSCO MD Online Portal
- Audit readiness and compliance training
- Query management and liaison with CDSCO officials
Our hands-on approach helps you minimize risks and accelerate market entry.
Getting Started with Your CDSCO License Application for Hand Pneumatic Lithotripsy System
Step 1: Confirm your device’s risk class and licensing pathway. As a Class B device, the MD5 manufacturing license is applicable.
Step 2: Register on the CDSCO MD Online Portal to initiate your application process.
Step 3: Prepare and submit your Test License application (Form MD13). Plan for 1.5 to 2 months for processing.
Step 4: Coordinate product testing at approved laboratories and gather detailed reports.
Step 5: Assemble your Device Master File and Plant Master File, ensuring all technical and quality documents are complete.
Step 6: Apply for the MD5 manufacturing license (Form MD3) and schedule the notified body audit.
Step 7: Address any queries promptly and maintain open communication with authorities.
Step 8: Upon license grant, implement ongoing compliance and post-market surveillance to sustain regulatory status.
We recommend engaging with experienced consultants early in the process to avoid common pitfalls and expedite approvals. Our proven track record and deep regulatory expertise make us the ideal partner for your CDSCO licensing journey.
By following these detailed steps and leveraging our expert guidance, manufacturers and importers can confidently navigate the CDSCO licensing process for the Hand Pneumatic Lithotripsy System and successfully access the Indian medical device market.
