CDSCO License for Lithotrite

Comprehensive Guide to CDSCO Licensing for Lithotrite Devices (Class B Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we understand the critical importance of obtaining the correct CDSCO licenses to enter the Indian market successfully. The Lithotrite, a Class B urology device used for the mechanical crushing of renal stones, requires careful navigation through India's regulatory framework to ensure compliance and timely approval.

CDSCO Regulatory Framework for Lithotrite (Class B Device)

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. The Lithotrite, classified as a Class B device due to its moderate risk profile, falls under the purview of State Licensing Authorities for manufacturing and Central Licensing Authority for import licenses.

Understanding the regulatory nuances specific to urology devices like the Lithotrite ensures your application aligns with the notified standards. The official notification (File No. 29/Misc./03/2020-DC (145)) dated 23.8.2021 confirms its classification and regulatory requirements.

Risk Classification and License Requirements for Lithotrite

The Lithotrite is a Class B medical device, which typically requires an MD5 manufacturing license and an MD15 import license if applicable. This classification mandates compliance with specific quality standards and testing protocols.

• Manufacturing License: MD5 (Application Form MD3) issued by the State Licensing Authority.
• Import License: MD15 (Application Form MD14) issued by the Central Licensing Authority.

Manufacturing License Process for Lithotrite (MD5)

1. Obtain Test License (Form MD13): Before applying for the manufacturing license, a test license is mandatory. This process typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing of the Lithotrite device at government-approved labs to validate safety and performance.
3. Document Preparation: Compile required documentation, including technical files and quality management systems.
4. Application Submission: Submit the manufacturing license application (Form MD3) through the CDSCO MD Online Portal.
5. Audit: Undergo an audit by a notified body listed in the Notified Bodies List for MD5 Audit.
6. Query Resolution: Address any queries raised by the department or notified body promptly.
7. License Grant: Upon successful completion, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required for Lithotrite

Preparation of comprehensive documentation is key to successful licensing. For a Class B device like Lithotrite, the following are essential:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist demonstrating compliance with safety and performance
• Risk Management File outlining identified risks and mitigation
• Product Test Reports from Government-approved Testing Laboratories (List of Testing Laboratories)
• Labeling and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 compliance)

Import License Process for Lithotrite (MD15)

If you plan to import the Lithotrite into India, the MD15 license is mandatory. The process includes:

1. Document Preparation: Assemble necessary documents, including manufacturing and quality certifications.
2. Application Submission: File the import license application Form MD14 via the CDSCO MD Online Portal.
3. Queries and Clarifications: Respond promptly to any departmental queries.
4. License Issuance: Upon satisfaction, the license is granted on Form MD15.

Notably, no test license is required for import licenses, but certifications such as CE Mark and ISO 13485:2016 are critical.

Import License Documents Required for Lithotrite

• Valid Manufacturing License from the Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

Our experience with over 500 companies shows that proactive document preparation and timely responses to queries significantly reduce processing delays.

Government Fees and Costs for Lithotrite Licensing

• MD5 Manufacturing License:
  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500
• MD15 Import License:
  • Site Fee (Class B): $2,000 (approx. INR 1.6 lakh)
  • Per Product Fee: $1,000 (approx. INR 80,000)

These fees are payable online through the CDSCO portal during the application process.

Common Challenges and Solutions

1. Incomplete Documentation: Missing or improperly prepared Device Master Files or Plant Master Files can delay approvals. We recommend using our detailed Device Master File Guide and Plant Master File Guide to ensure completeness.

2. Delays in Product Testing: Testing at government-approved labs can bottleneck the timeline. Early scheduling and coordination with testing labs (Testing Laboratories List) can mitigate this.

3. Audit Non-Compliance: Not adhering to notified body audit requirements may result in repeated audits. Familiarize yourself with the list of notified bodies and prepare thoroughly.

4. Query Resolution Delays: Prompt and clear responses to departmental queries are essential. We advise maintaining a dedicated regulatory liaison to manage communications.

Expert Consultation and Support

With our 25+ years of assisting over 500 medical device companies, we provide end-to-end support for CDSCO licensing of Lithotrite devices. From documentation to audit readiness and query management, our expert team ensures your application progresses seamlessly.

Our services include:

• Gap analysis for documentation and quality systems
• Coordination with notified bodies and testing labs
• Preparation of Device and Plant Master Files
• Regulatory strategy for import and manufacturing licenses
• Post-approval compliance assistance

Getting Started with Your CDSCO License Application for Lithotrite

1. Assess your product classification: Confirm the Lithotrite as Class B under CDSCO guidelines (Medical Device Classification).
2. Prepare your technical documentation: Utilize expert guides to develop robust Device and Plant Master Files.
3. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to begin testing approvals.
4. Engage with notified bodies early: Schedule audits and clarify requirements.
5. Compile and submit Manufacturing License Application (MD5): Once testing and audits are complete.
6. If importing, prepare import documentation and apply for MD15 license accordingly.

Taking these practical steps with experienced regulatory support substantially increases your chances of a smooth, timely CDSCO license grant for your Lithotrite device.

For personalized assistance tailored to your manufacturing or import scenario, contact us today to leverage our industry-leading expertise and ensure your compliance journey is efficient and successful.