CDSCO License for Piezoelectric lithotripsy system

Comprehensive Guide to CDSCO Licensing for Piezoelectric Lithotripsy Systems (Class C Medical Device)

As a trusted regulatory consultancy with over 25 years of experience assisting 500+ medical device manufacturers and importers, we understand the critical importance of navigating the CDSCO licensing process smoothly and efficiently. The piezoelectric lithotripsy system, classified as a Class C medical device under CDSCO regulations, plays a vital role in urology by non-invasively disintegrating kidney and urinary stones using focused shock waves generated by piezoelectric elements. Given its complexity and higher risk classification, obtaining the correct license is crucial to legally manufacture or import this device into India.

CDSCO Regulatory Framework for Piezoelectric Lithotripsy Systems

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules (MDR) 2017. The piezoelectric lithotripsy system falls under Class C due to its invasive and therapeutic nature, requiring a centralized licensing process. The regulatory framework mandates conformity with safety, performance, and quality standards, including compliance with Essential Principles and risk management protocols.

Risk Classification and License Requirements

• Device: Piezoelectric Lithotripsy System
• Risk Class: Class C
• License Type: MD9 (Manufacturing License for Class C/D Devices)
• Regulatory Authority: Central Licensing Authority, CDSCO

Class C devices like this require rigorous scrutiny including product testing, documentation review, and factory audit before license approval. For detailed classification criteria, refer to our Medical Device Classification guide.

Manufacturing License Process (MD9 License)

The MD9 license process involves several essential stages:

1. Test License Application (Form MD13): Initiate with a test license to legally produce samples for testing. Processing time is typically 1.5 to 2 months.

2. Product Testing: Get your device tested at CDSCO-approved laboratories. Testing ensures compliance with applicable standards. You can find a list of approved Testing Laboratories here.

3. Document Preparation: Compile a comprehensive dossier including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System documentation.

4. License Application Submission (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Inspection and Audit: CDSCO inspectors conduct a thorough audit of your manufacturing facility and documentation.

6. Query Resolution: Address any queries raised by CDSCO during the review process promptly.

7. Grant of License (Form MD9): Upon satisfactory compliance, the license is granted.

For a step-by-step walkthrough, see our detailed MD9 License Guide.

Manufacturing License Documents Required

Successful license application hinges on meticulous documentation. For your piezoelectric lithotripsy system, prepare the following:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing, and performance (see our Device Master File Guide)
• Plant Master File (PMF) describing manufacturing environment and processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System documentation, preferably ISO 13485:2016 certification

Import License Process (MD15 License)

If you intend to import the piezoelectric lithotripsy system, the import license (MD15) is mandatory:

1. Document Preparation: Assemble manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, and company constitution.

2. License Application: Submit Form MD14 for MD15 license via the CDSCO MD Online Portal.

3. Review and Query Resolution: CDSCO evaluates documents and may raise queries.

4. Grant of License: Upon satisfactory compliance, MD15 license is issued.

Refer to our Import License Guide for detailed insights.

Timeline and Processing Duration

• MD9 Manufacturing License: Approximately 4 to 5 months

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 1 to 1.5 months
  • Audit and Review: 1 to 1.5 months

• MD15 Import License: Approximately 5 to 6 months

Based on our extensive experience, proactive document preparation and rapid response to CDSCO queries can significantly reduce delays.

Government Fees and Costs

• MD9 License Application Fee: Rs. 50,000 per application
• Per Product Fee: Rs. 1,000 for each product included
• Testing Costs: Varies based on test scope; typically Rs. 1-2 lakhs for complex devices
• Audit Fees: Usually borne by the applicant as per notified body charges

Note that these fees are subject to change; always verify current fees on the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or inadequate product testing.

Solution: Engage experienced consultants early to audit your documentation and coordinate with CDSCO-approved laboratories. Utilize our comprehensive checklists and guides to avoid common pitfalls.

Challenge: Difficulty in scheduling timely audits by CDSCO inspectors.

Solution: Schedule audits well in advance and ensure all manufacturing processes comply strictly with GMP and ISO standards.

Challenge: Managing multiple product variants within a single license application.

Solution: Prepare separate technical documentation for each product variant and clearly delineate them in the license application.

Expert Consultation and Support

Our team has helped over 500 companies successfully navigate the CDSCO licensing landscape. We provide end-to-end support from initial classification, documentation preparation, liaison with notified bodies, to post-approval compliance. Leveraging our expertise reduces approval timelines and mitigates regulatory risks.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm the Class C status and regulatory pathway.
2. Create a Project Timeline: Allocate 5-6 months for the end-to-end process.
3. Prepare Documentation: Develop your DMF, PMF, risk management files, and QMS documentation.
4. Initiate Test License (MD13): Apply via the CDSCO MD Online Portal to start sample production.
5. Coordinate Product Testing: Engage CDSCO-approved labs early to avoid bottlenecks.
6. Compile and Submit MD9 License Application: Once testing is complete, submit Form MD7 with all required documents.
7. Prepare for Audits: Schedule and prepare for CDSCO inspections.
8. Monitor Application Status: Promptly respond to any queries.

Embarking on this journey with professional assistance enhances your chance of success. Contact us to leverage our proven regulatory strategies tailored specifically for piezoelectric lithotripsy systems and Class C medical devices.

By following these carefully outlined steps, you can confidently achieve compliance and bring your innovative urology devices to the Indian market.