CDSCO License for An endolymphatic shunt tube with valve

Introduction to Endolymphatic Shunt Tube with Valve and Its Regulatory Importance

An endolymphatic shunt tube with valve is a specialized internal prosthetic replacement device designed to alleviate vertigo and hearing loss by regulating inner ear pressure. This critical medical device features a pressure-limiting valve integrated with an implantable tube, making it a Class C medical device under Indian regulations. Given its invasive nature and risk profile, obtaining the correct CDSCO license is essential to legally manufacture or import this device into the Indian market.

Navigating the regulatory landscape for such a device can be complex. With over 25 years of experience and having supported 500+ companies, we understand the intricacies involved and can guide you through a smooth licensing process.

CDSCO Regulatory Framework for Endolymphatic Shunt Tube with Valve

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India as per the Medical Device Rules, 2017. The endolymphatic shunt tube with valve falls under the category of internal prosthetic replacements and is classified as a Class C device due to its moderate to high risk.

This classification mandates a license from the Central Licensing Authority, involving a rigorous process including product testing, documentation, and audits to ensure patient safety and compliance with Indian standards.

Risk Classification and License Requirements for Class C Devices

According to the Medical Device Classification, Class C devices represent moderate to high risk devices that require:

• An MD9 manufacturing license (Form MD7) for domestic manufacturing
• An MD15 import license (Form MD14) for importing the device into India

For the endolymphatic shunt tube with valve, the MD9 license is mandatory if manufacturing locally. This license is granted by the Central Licensing Authority after fulfilling all regulatory requirements.

Manufacturing License Process (MD9) for Endolymphatic Shunt Tube with Valve

Step 1: Obtain a Test License (Form MD13)

Before applying for the MD9 license, manufacturers must first secure a test license on Form MD13. This license permits initial testing of the device in government-approved laboratories.

Step 2: Product Testing

The device must undergo rigorous testing at CDSCO-recognized labs. Refer to the list of testing laboratories to select an approved facility. Testing typically covers biocompatibility, mechanical integrity, and functional performance of the valve and tube.

Step 3: Documentation Preparation

Prepare comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

Step 4: Application Submission (Form MD7)

Submit the manufacturing license application on Form MD7 via the CDSCO MD Online Portal along with all required documents.

Step 5: Audit by CDSCO Inspectors

Following document review, CDSCO inspectors conduct audits to verify compliance with Good Manufacturing Practices (GMP) and the QMS.

Step 6: Address Queries

Respond promptly to any queries or deficiencies raised during the audit or document review to avoid delays.

Step 7: License Grant (Form MD9)

Upon successful completion of all steps, the MD9 manufacturing license is granted, authorizing you to produce the device in India.

For a detailed walkthrough, view our MD9 License Guide.

Manufacturing License Documents Required for Class C Device

1. Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
2. Proof of ownership/lease of manufacturing premises
3. Qualification and experience details of technical staff
4. Fire NOC and Pollution Control Board NOC
5. Device Master File detailing design and specifications (Device Master File Guide)
6. Plant Master File describing manufacturing processes (Plant Master File Guide)
7. Essential Principles Checklist confirming compliance with safety and performance
8. Risk Management File as per ISO 14971 standards (Risk Management)
9. Test Reports from CDSCO-approved labs
10. Product Labels and Instructions for Use (IFU)
11. Quality Management System documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Endolymphatic Shunt Tube with Valve

If you intend to import this Class C device into India, the MD15 license is mandatory.

Application Steps:

• Compile required documents including manufacturing license, free sale certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
• Submit the application on the CDSCO MD Online Portal using Form MD14.
• Address any departmental queries.
• Upon satisfactory review, the license is granted.

Refer to our Import License Guide for detailed insights.

Import License Documents Required

1. Valid manufacturing license (MD9 or equivalent)
2. Free Sale Certificate from country of origin
3. ISO 13485:2016 certification
4. CE Certificate or equivalent regulatory approval
5. Device Master File
6. Plant Master File
7. Wholesale License (if applicable)
8. Company Constitution

Timeline and Processing Duration

• Test License (Form MD13): Approximately 1.5 to 2 months
• Product Testing: 1 to 2 months depending on lab availability
• MD9 License Application to Grant: 2 to 3 months

Total estimated timeline: 4 to 5 months from start to finish for the manufacturing license.

For the import license (MD15), the process typically takes 5 to 6 months.

Government Fees and Costs

• MD9 Manufacturing License: Rs. 50,000 per application + Rs. 1,000 per product
• Test License: Included within MD9 process costs
• Import License (MD15): Class C & D devices attract Rs. 3,000 per site + Rs. 1,500 per product

Additional costs may include testing fees at government-approved labs and fees charged by notified bodies during audits.

Common Challenges and Practical Solutions

• Delayed Test Reports: Early booking of government-approved labs is critical due to high demand. Utilize the Testing Laboratories list to identify options.

• Incomplete Documentation: Maintain a checklist and adopt templates for Device and Plant Master Files to avoid rejection.

• Audit Non-Compliance: Conduct mock audits and internal quality reviews prior to CDSCO inspection.

• Query Resolution Delays: Assign a dedicated regulatory liaison to respond swiftly and comprehensively to CDSCO communications.

Expert Consultation and Support

Given the complexity of obtaining an MD9 license for a Class C device like the endolymphatic shunt tube with valve, partnering with experienced regulatory consultants can significantly reduce time and risk.

Our team has successfully guided over 500 companies through CDSCO licensing, offering end-to-end support including document preparation, audit readiness, and application submission.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device’s classification as Class C using the Medical Device Classification resources.

2. Prepare Technical Files: Begin compiling your Device Master File and Plant Master File early, referencing our comprehensive guides.

3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal to initiate product testing.

4. Schedule Testing: Coordinate with CDSCO-approved labs to align testing timelines with your overall project schedule.

5. Engage a Notified Body: Identify and liaise with a notified body for the mandatory audit. See the List of Notified Bodies.

6. Submit MD9 Application: Once testing and documentation are complete, file your manufacturing license application.

7. Prepare for Audit: Conduct internal audits and ensure all QMS and GMP standards are in place.

8. Respond Promptly: Address any queries from CDSCO or auditors swiftly to avoid delays.

Starting early, staying organized, and seeking expert guidance can make the difference between a smooth approval and frustrating delays. Contact us to leverage our proven expertise for your endolymphatic shunt tube with valve licensing journey.