CDSCO License for Endolymphatic shunt

Understanding Endolymphatic Shunt and Its Regulatory Significance

An Endolymphatic Shunt is a critical internal prosthetic replacement device designed to be implanted to alleviate vertigo symptoms. Given its invasive nature and implantation within the human body, it is classified as a Class C medical device under the CDSCO framework. This classification reflects a moderate to high risk, emphasizing stringent regulatory compliance to ensure patient safety and product efficacy.

Our 25+ years of regulatory expertise and support to over 500 medical device companies uniquely positions us to guide manufacturers and importers through the complex CDSCO licensing process specific to devices like the Endolymphatic Shunt.

CDSCO Regulatory Framework for Endolymphatic Shunts

The Central Drugs Standard Control Organization (CDSCO) governs the manufacturing, import, and sale of medical devices in India. For Class C devices such as the Endolymphatic Shunt, licenses are granted by the Central Licensing Authority. Regulatory compliance includes adherence to the Medical Device Rules 2017, including the specific notification 29/Misc/3/2017-DC (292) dated 06.06.2018, which governs this device category.

Risk Classification and License Requirements for Endolymphatic Shunts

Endolymphatic Shunts are categorized as Class C devices due to their implanted nature and potential risk factors. This classification mandates the acquisition of an MD9 manufacturing license for domestic production and an MD15 import license for imported devices.

MD9 Manufacturing License (Form MD7): Required for manufacturing Class C devices within India.
MD15 Import License (Form MD14): Required for importing Class C devices into India.

For detailed classification insights, visit our Medical Device Classification guide.

Manufacturing License Process for Endolymphatic Shunts (MD9)

Obtaining an MD9 license involves a comprehensive multi-step process:

Test License Application (Form MD13): Initiate by applying for a test license, which takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to validate safety and performance. Refer to the Testing Laboratories list.
Document Preparation: Assemble all required documentation (detailed below).
License Application (Form MD7): Submit the MD9 manufacturing license application via the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors conduct audits of facilities and quality management systems.
Query Resolution: Address any queries raised by the CDSCO during the review.
License Grant: Upon successful completion of all steps, the MD9 license is granted.

For an in-depth understanding, consult our MD9 License Guide.

Manufacturing License Documents Required for Endolymphatic Shunts

The documentation is critical and meticulous. Key documents include:

Company Constitution and Registration Proof
Proof of Ownership or Lease Agreement of Manufacturing Premises
Details and Qualifications of Technical Staff
Fire Safety NOC and Pollution Control NOC
Device Master File (DMF): Comprehensive technical data on the Endolymphatic Shunt. Learn more in our Device Master File guide.
Plant Master File (PMF): Details about the manufacturing facility complying with regulatory standards. See our Plant Master File Guide.
Essential Principles Checklist verifying compliance with safety and performance standards
Risk Management File demonstrating risk assessment and mitigation, tailored to implantable devices. Explore best practices in Risk Management.
Product Test Reports from CDSCO-approved labs
Labels and Instructions for Use (IFU) complying with Indian regulations
Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process for Endolymphatic Shunts (MD15)

For importers, the MD15 license is mandatory. The process typically spans 5-6 months and comprises:

Document Preparation: Gather all necessary documents prior to application.
License Application (Form MD14): Submit through the CDSCO MD Online Portal.
Review and Queries: CDSCO evaluates the submission and raises queries if required.
License Grant: Upon satisfactory review, the MD15 import license is issued.

Unlike the manufacturing license, a test license is not mandatory here, but compliance with standards and documentation is rigorously assessed.

Import License Documents Required for Endolymphatic Shunts

Key documentation includes:

Valid Manufacturing License from the country of origin
Free Sale Certificate issued by the foreign regulatory authority
ISO 13485:2016 Certification
CE Certificate or equivalent international certification
Device Master File and Plant Master File
Wholesale Drug License (if applicable)
Company Constitution and Registration Proof
Details of the Indian importer

Refer to our detailed Import License Guide for comprehensive support.

Timeline and Processing Duration for Endolymphatic Shunt Licenses

MD9 Manufacturing License: Approximately 4 to 5 months total.
- Test License (MD13): 1.5 to 2 months
- Product Testing: 2 to 3 weeks
- Audit and Query Resolution: 1 to 1.5 months
MD15 Import License: Approximately 5 to 6 months.

Planning well ahead is essential to align market entry with regulatory approvals.

Government Fees and Costs for Endolymphatic Shunt Licensing

MD9 Manufacturing License:
- Application Fee: Rs 50,000
- Per Product Fee: Rs 1,000
MD15 Import License:
- Site Fee for Class C devices: $3,000
- Per Product Fee: $1,500

These fees are payable online during application submission on the CDSCO portal.

Common Challenges and Solutions When Licensing Endolymphatic Shunts

Challenge 1: Document Gaps and Non-Compliance

Solution: Utilize detailed checklists and consult with regulatory experts to ensure completeness. Our experience shows that missing Device Master File elements often delay processing.

Challenge 2: Delays in Product Testing

Solution: Pre-select CDSCO-approved labs early and schedule testing to avoid bottlenecks. Refer to the official Testing Laboratories.

Challenge 3: Audit Non-Conformities

Solution: Conduct pre-audit internal reviews to align QMS and plant standards with CDSCO expectations. Engage notified bodies early; see the Notified Bodies List.

Challenge 4: Query Management

Solution: Provide clear, prompt, and detailed responses to regulatory queries to expedite approvals.

Expert Consultation and Support for Endolymphatic Shunt Manufacturers and Importers

Navigating the CDSCO landscape for Class C implantable devices demands expertise. Our consultancy offers:

End-to-end application preparation and submission
Regulatory gap analysis and compliance audits
Training on regulatory requirements and QMS implementation
Liaison with CDSCO and notified bodies

Our track record with over 500 successful CDSCO license approvals speaks for itself.

Getting Started with Your CDSCO License Application for Endolymphatic Shunts

Classify Your Device: Confirm Class C status and regulatory requirements.
Prepare Documentation: Begin compiling the Device Master File, Plant Master File, and Risk Management File.
Apply for Test License (MD13): Initiate testing phase to validate product safety.
Engage Approved Testing Labs: Schedule and complete product testing promptly.
Submit Manufacturing License Application (MD7): Once test reports are ready, submit your MD9 application.
Prepare for Audit: Ensure your facility and QMS are audit-ready.
Respond to Queries: Maintain open communication channels with CDSCO.
Plan Import License Application: If importing, concurrently prepare MD15 application documents.

Submit your applications through the CDSCO MD Online Portal, and leverage our consulting expertise for a smooth, timely approval process.

By following these pragmatic steps and leveraging our deep regulatory experience, manufacturers and importers of Endolymphatic Shunts can confidently navigate the CDSCO licensing pathway and bring this critical medical device to the Indian market efficiently and compliantly.