CDSCO License for Leukotome

Comprehensive Guide to CDSCO Licensing for Leukotome (Class B Neurological Device)

Leukotome, a specialized neurological medical device designed to cut brain tissue (white matter) for leukotomy procedures, falls under the Class B risk category as per CDSCO regulations. Given its critical use in delicate brain surgeries, obtaining a CDSCO manufacturing license is paramount to ensure compliance with Indian medical device regulations and patient safety standards.

With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide you with detailed, practical guidance on navigating the regulatory pathway for Leukotome under the Class B category.

CDSCO Regulatory Framework for Leukotome

Leukotome is notified under the classification 29/Misc/03/2020-DC (201) dated 27.09.2021. Being a Class B device, the regulatory authority overseeing its manufacturing license is the State Licensing Authority. The licensing process is governed by the Medical Devices Rules, 2017, which align with the Global Harmonization Task Force (GHTF) principles, ensuring devices meet essential safety and performance standards.

You must submit your application through the CDSCO MD Online Portal, which streamlines the entire licensing process.

Risk Classification and License Requirements for Leukotome

• Device Risk Class: B (Low Moderate Risk)
• License Type: MD5 Manufacturing License
• Application Form: MD3
• Regulatory Authority: State Licensing Authority
• Typical Processing Time: 3-4 months (including test license, testing, audit)

This classification mandates a test license (Form MD13) before full license application, mandatory product testing at CDSCO-approved labs, and an audit by a notified body.

Learn more about Medical Device Classification.

Manufacturing License Process (MD5) for Leukotome

1. Obtain Test License (Form MD13): Apply for a test license which takes approximately 1.5 to 2 months. This enables you to manufacture test samples for product evaluation.
2. Product Testing: Conduct mandatory testing at government-approved testing laboratories to validate safety and performance requirements. Refer to the list of testing laboratories for authorized facilities.
3. Prepare Documents: Compile required documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, labels, Instructions for Use (IFU), and Quality Management System (QMS) documents.
4. Submit MD5 License Application (Form MD3): Upload your application along with all supporting documents on the CDSCO MD Online Portal.
5. Notified Body Audit: A notified body conducts a thorough audit of your manufacturing facility and QMS. Check the list of notified bodies to select an authorized auditor.
6. Query Resolution: Address any queries raised by the CDSCO or notified body promptly to avoid delays.
7. License Grant: Upon satisfactory review and audit clearance, the State Licensing Authority issues the MD5 license on Form MD5.

For an in-depth understanding, see our MD5 License Guide.

Manufacturing License Documents Required for Leukotome

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing process, and controls (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing facilities and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance
• Risk Management File per ISO 14971 principles (Risk Management Guide)
• Product Test Reports from approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System documentation (e.g., ISO 13485:2016 certificate)

Import License Process (MD15) for Leukotome

If you are importing Leukotome into India, the applicable CDSCO license is the Import License (MD15) granted by the Central Licensing Authority.

Key steps include:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate (if applicable), Device Master File, Plant Master File, Wholesale License, Company Constitution.
• Submission of application on the CDSCO MD Online Portal using Form MD14.
• Resolution of any queries raised by CDSCO.
• License grant on Form MD15.

The entire import license process typically takes 5-6 months. For more details, review our Import License Guide.

Import License Documents Required for Leukotome

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

Timeline and Processing Duration for Leukotome Licensing

Planning your timelines with buffer for audit scheduling and query resolution is critical to avoid delays.

Government Fees and Costs for Leukotome MD5 License

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

Additional costs to consider:

• Testing fees at government-approved labs
• Notified body audit charges
• Professional consultancy fees (if applicable)

Common Challenges and Solutions

• Delays in Product Testing: Ensure samples meet testing lab requirements and submit complete documentation to avoid retesting.
• Audit Non-compliance: Conduct a pre-audit internal assessment, maintain robust QMS, and ensure staff are trained on regulatory expectations.
• Document Gaps: Use checklist-based document preparation referencing regulatory guidelines and leverage our Device Master File guide and Plant Master File guide.
• Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries to maintain application momentum.

Expert Consultation and Support

Navigating CDSCO licensing for a Class B neurological device like Leukotome requires precision and regulatory expertise. Our team’s extensive experience in successfully guiding 500+ companies through the process ensures:

• Tailored regulatory strategy
• Complete and compliant documentation
• Liaison with notified bodies and CDSCO
• Efficient query management
• Timely license acquisition

Getting Started with Your CDSCO License Application for Leukotome

1. Assess Your Device Classification: Confirm that Leukotome is Class B and requires MD5 licensing.
2. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the submission process.
3. Engage with a Notified Body: Select an appropriate notified body early from the notified bodies list to schedule audits.
4. Initiate Test License Application (Form MD13): Submit your test license application to enable product testing.
5. Coordinate Product Testing: Send samples to CDSCO-approved labs and obtain test reports.
6. Prepare and Compile Documents: Utilize our guides on Device Master File and Plant Master File to ensure completeness.
7. Submit MD5 License Application (Form MD3): Upload all documents and pay applicable fees.
8. Prepare for Audit: Conduct internal pre-audit checks and train staff.
9. Respond to Queries Promptly: Maintain active communication with CDSCO and the notified body.

By following these steps and leveraging expert support, you can confidently navigate the regulatory requirements and bring your Leukotome device to the Indian market efficiently and compliantly.