CDSCO License for Stereotactic neuronavigation/ planning system

Comprehensive Guide to CDSCO Licensing for Stereotactic Neuronavigation/Planning System (Class B Medical Device)

At our consulting firm, with over 25 years of experience and having supported 500+ companies in medical device registration, we fully understand the complexities involved in obtaining regulatory approvals for advanced neurological devices like the Stereotactic Neuronavigation/Planning System. This device, classified as Class B by CDSCO, plays a critical role in neurosurgical procedures by providing real-time 3D positioning through analysis of MRI images, making regulatory compliance essential to ensure safety and efficacy.

CDSCO Regulatory Framework for Stereotactic Neuronavigation Systems

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. The Stereotactic Neuronavigation system falls under Class B due to its moderate risk profile involving critical patient data analysis and positioning accuracy. Compliance with CDSCO’s licensing ensures your device meets Indian safety standards and can be legally manufactured or imported.

Risk Classification and License Requirements

As a Class B device, the Stereotactic Neuronavigation/Planning System requires an MD5 manufacturing license if produced in India or an MD15 import license if imported. The MD5 license is issued by the State Licensing Authority and involves several steps including testing, audit, and documentation.

For detailed classification insights, you can refer to our Medical Device Classification resource.

Manufacturing License Process (MD5) for Class B Neurological Devices

1. Test License Application (Form MD13): Before applying for the manufacturing license, you must obtain a test license, valid for up to 2 years, which allows you to manufacture and test the device.

2. Product Testing: Conduct product testing at CDSCO-approved government laboratories to verify compliance with Indian standards. Refer to the list of Testing Laboratories authorized by CDSCO.

3. Document Preparation: Prepare all essential documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.

4. License Application (Form MD3): Submit your manufacturing license application online through the CDSCO MD Online Portal.

5. Audit by Notified Body: A mandatory audit by a CDSCO-recognized notified body is conducted to assess compliance with quality system regulations. Check the list of notified bodies for your region.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly to avoid delays.

7. Grant of License (Form MD5): Upon successful audit and document verification, the MD5 license is granted.

Manufacturing License Documents Required for Stereotactic Neuronavigation Systems

• Company Constitution documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing device design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management Guide)
• Test reports from CDSCO-approved laboratories
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (preferably ISO 13485 certified)

Import License Process (MD15) for Stereotactic Neuronavigation Systems

If you are an importer of this Class B device, the MD15 import license is mandatory and issued by the Central Licensing Authority. The process steps include:

1. Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate or equivalent, Device and Plant Master Files, Wholesale License, and Company Constitution.

2. Application Submission: File the license application on Form MD14 via the CDSCO MD Online Portal.

3. Query Resolution: Respond to any CDSCO department queries.

4. Grant of License: Once verified, the MD15 import license is issued.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate demonstrating market approval in the country of manufacture
• ISO 13485:2016 Quality Management System certification
• CE Marking Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution documents

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3 to 4 months, including:

  • Test license (MD13): 1.5 to 2 months
  • Product testing: 2 to 3 weeks
  • Audit scheduling and completion: 3 to 4 weeks
  • Query resolution and final approval: 3 to 4 weeks

• MD15 Import License: Typically 5 to 6 months from application submission to license grant.

Timely preparation and proactive responses to queries are key to staying within these timelines.

Government Fees and Costs

• MD5 Manufacturing License (Class B):

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

• MD15 Import License (Class B):

  • Site fee: $2,000 USD
  • Product fee: $1,000 USD per product

Additional costs include fees for product testing at government labs and audit charges by notified bodies.

Common Challenges and Solutions

• Delayed Testing: Testing laboratories can have backlogs; early booking and submission of samples can mitigate delays.

• Incomplete Documentation: Missing or improperly prepared Device Master Files or Risk Management Files often cause rejections. Our experts assist in preparing compliant, audit-ready documents.

• Audit Non-Compliance: Unprepared facilities or lack of QMS adherence can result in failed audits. Conducting pre-audit internal reviews and training staff is crucial.

• Query Resolution Delays: Slow responses to CDSCO queries can prolong the licensing process. Assign dedicated regulatory personnel for prompt action.

Expert Consultation and Support

Navigating CDSCO regulations for neurological Class B devices like the Stereotactic Neuronavigation system requires specialized expertise. Our team provides end-to-end support—from preparing test license applications, compiling robust documentation, coordinating with notified bodies, to managing audits and responding to regulatory queries.

Explore our detailed MD5 License Guide to understand the nuances of this process.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B under CDSCO rules.

2. Initiate Test License Application (MD13): Prepare and submit your test license application via the CDSCO MD Online Portal.

3. Plan Product Testing: Schedule testing with CDSCO-recognized labs early to avoid bottlenecks.

4. Prepare Documentation: Begin assembling your Device Master File, Plant Master File, Risk Management File, and other required documents.

5. Schedule Pre-Audit Readiness: Conduct internal audits and gap assessments.

6. Submit Manufacturing License Application (MD3) Online: Once test license and testing are complete.

7. Coordinate with Notified Body for Audit: Ensure full compliance and readiness.

8. Respond Promptly to Queries: Maintain open communication with CDSCO.

9. Receive MD5 License: Begin manufacturing and marketing your device legally in India.

For manufacturers and importers aiming to enter the Indian neurological device market with the Stereotactic Neuronavigation system, meticulous planning, expert guidance, and timely action are imperative. Contact us for a personalized consultation to streamline your CDSCO licensing journey.