CDSCO License for Foetal bladder shunt
Medical Device Information
Intended Use
A sterile non-bioabsorbable tubular device implanted in the bladder of a foetus with post-vesicular obstructive uropathy, to decompress the urinary tract for urine to pass from bladder into the amniotic sac, until the defect can be surgically repaired after birth
Comprehensive Guide to CDSCO Licensing for Foetal Bladder Shunt (Class C Medical Device)
As specialists with over 25 years of experience and having assisted 500+ medical device companies in India, we understand the critical importance of securing the correct CDSCO license for your product. The Foetal Bladder Shunt, a Class C obstetrical and gynecological medical device, requires meticulous adherence to the regulatory framework to ensure timely market entry and compliance.
Understanding the Foetal Bladder Shunt and Its Regulatory Importance
The Foetal Bladder Shunt is a sterile, non-bioabsorbable tubular implant designed to alleviate post-vesicular obstructive uropathy in foetuses by decompressing the urinary tract. This device facilitates urine passage from the bladder into the amniotic sac until surgical correction post-birth is possible. Given its life-critical intended use and invasive nature, the device falls under Class C risk classification, necessitating a rigorous regulatory pathway.
CDSCO Regulatory Framework for Obstetrical and Gynecological Devices
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. For Class C devices like the Foetal Bladder Shunt, the regulatory oversight is centralized and involves comprehensive evaluation including product testing, documentation, and audits under the Medical Device Rules, 2017.
For detailed classification, refer to our guide on Medical Device Classification.
Risk Classification and License Requirements for Foetal Bladder Shunt
- Risk Class: Class C (Moderate to high risk)
- License Type: MD9 Manufacturing License (Form MD7)
- Authority: Central Licensing Authority (CDSCO)
The MD9 license covers manufacturing of Class C and D devices and demands higher scrutiny compared to Class A/B devices.
MD9 Manufacturing License Process for Class C Devices
The entire licensing process for the Foetal Bladder Shunt typically spans 4 to 5 months and involves several key stages:
- Test License Application (Form MD13):
- Duration: 1.5 to 2 months
- Purpose: To manufacture the device for testing and evaluation
- Product Testing:
- Conducted at CDSCO-approved government laboratories to ensure compliance with essential principles and safety standards.
- Access the List of Testing Laboratories for authorized facilities.
- Documentation Preparation:
- Compilation of technical files including Device Master File and Plant Master File.
- Submission of MD9 License Application (Form MD7):
- Via the CDSCO MD Online Portal.
- Inspection and Audit:
- Conducted by CDSCO Inspectors to verify compliance with QMS and manufacturing practices.
- Resolution of Queries:
- Address any observations or deficiencies raised during audit.
- Grant of MD9 License (Form MD9):
For an in-depth walkthrough, see our MD9 License Guide.
Essential Documents Required for MD9 License Application
To streamline your application, ensure the following documents are meticulously prepared and submitted:
- Company Constitution Documents: Incorporation certificate, partnership deed, etc.
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Details: Qualifications and experience of key personnel
- Fire NOC and Pollution Control NOC: As applicable
- Device Master File (DMF): Detailed design, specifications, and manufacturing process. Our Device Master File guide provides comprehensive assistance.
- Plant Master File (PMF): Information on manufacturing facilities and quality systems. Refer to our Plant Master File Guide.
- Essential Principles Checklist: Compliance with Indian Medical Device Rules
- Risk Management File: Documented risk analysis and mitigation strategies. Learn more in our Risk Management guide.
- Test Reports from Approved Laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System Documents: ISO 13485:2016 certifications, SOPs
Import License Process (MD15) for Foetal Bladder Shunt
If you are an importer of the Foetal Bladder Shunt, the MD15 import license granted by the Central Licensing Authority is mandatory. The process typically takes 5 to 6 months and includes:
- Document preparation and submission via the CDSCO MD Online Portal
- Review and resolution of queries
- License grant on Form MD15
Required documents include:
- Manufacturing License (MD9) from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
Refer to our detailed Import License Guide for assistance.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation Preparation | 2 - 3 weeks |
| MD9 License Application & Audit | 1.5 - 2 months |
| Total Time | 4 - 5 months |
Government Fees and Cost Structure
- Test License (MD13): Typically included in overall costs
- MD9 License Application Fee: Rs. 50,000 per application
- Product Fee: Rs. 1,000 per product
These fees are payable through the CDSCO MD Online Portal during application submission.
Common Challenges in Licensing Foetal Bladder Shunt and Practical Solutions
- Document Gaps: Missing or incomplete Device Master File or Risk Management File often delays approvals. We recommend early preparation and expert review.
- Testing Delays: Limited availability of government-approved labs can bottleneck testing. Plan testing schedules well in advance.
- Audit Non-Compliance: Gaps in QMS documentation or facility readiness can trigger non-conformities during CDSCO inspections. Conduct mock audits beforehand.
- Query Resolution: Delayed responses to CDSCO queries extend timelines. Assign dedicated regulatory personnel to manage communication promptly.
Expert Consultation and Support
Navigating the CDSCO licensing pathway for Class C devices like the Foetal Bladder Shunt can be complex. Our expert consultants provide tailored support including:
- Gap analysis and documentation assistance
- Audit preparation and liaison with notified bodies
- Strategic planning to optimize timelines
- End-to-end application management
Getting Started with Your CDSCO License Application
- Assess Classification: Confirm your device is Class C using the CDSCO classification tool.
- Prepare Technical Files: Compile DMF, PMF, Risk Management File, and QMS documentation.
- Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with approved labs early.
- Complete Documentation: Address audit requirements fully.
- Submit MD9 License Application: Upload all documents and pay fees online.
- Prepare for CDSCO Audit: Engage with notified bodies and ensure compliance.
- Respond to Queries Promptly: Allocate resources for timely communication.
By following these steps and leveraging our 25+ years of regulatory expertise, manufacturers and importers of the Foetal Bladder Shunt can confidently navigate the CDSCO licensing process, ensuring compliance and faster market access.
For personalized assistance and to accelerate your licensing journey, feel free to contact us. Our proven track record in securing CDSCO approvals for Class C medical devices speaks volumes about our commitment and proficiency.
