CDSCO License for Root Canal Filling removal Solution

Introduction to Root Canal Filling Removal Solution and Regulatory Importance

Root Canal Filling Removal Solution is a specialized dental device designed for endodontic use, primarily to soften and remove root canal fillings during dental procedures. Comprising solvents such as tetrachloroethylene, formamide, eucalyptol, and excipients, this liquid solution plays a crucial role in effective root canal retreatment.

Given its chemical composition and direct application in sensitive dental treatments, regulatory compliance is paramount. Ensuring that your Root Canal Filling Removal Solution meets the Central Drugs Standard Control Organization (CDSCO) requirements not only guarantees safety and efficacy but also facilitates smooth market entry in India.

With over 25 years of experience and 500+ successful CDSCO licensing projects, we understand the nuances and critical steps involved in obtaining your license efficiently.

CDSCO Regulatory Framework for Dental Devices: Root Canal Filling Removal Solution

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017. Dental devices, including Root Canal Filling Removal Solutions, fall under specific categories based on risk classification and intended use.

This particular device is notified under Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, which classifies it as a Class B device. As such, it is subject to regulatory controls ensuring quality, safety, and performance.

Risk Classification and License Requirements for Class B Dental Devices

Root Canal Filling Removal Solution is categorized as a Class B device due to its moderate risk profile: it involves chemical solvents and direct interaction with internal tissues.

For Class B devices, the CDSCO mandates an MD5 manufacturing license obtained from the State Licensing Authority. The MD5 license application is submitted using Form MD3 through the CDSCO MD Online Portal.

The process includes initial test licensing, product testing, documentation, audit by a notified body, and final license issuance.

Manufacturing License Process (MD5) for Root Canal Filling Removal Solution

Step 1: Obtain Test License (Form MD13)

Before applying for the manufacturing license, manufacturers must secure a test license to manufacture the product for testing purposes. This takes approximately 1.5 to 2 months.

Step 2: Product Testing at Government-Approved Laboratories

Once the test license is granted, product samples undergo rigorous testing at CDSCO-approved labs. A list of these Testing Laboratories ensures compliance with Indian quality standards.

Step 3: Documentation Preparation

Simultaneously, prepare critical documentation such as Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documents.

Step 4: License Application (Form MD3)

Submit the MD5 license application through the CDSCO MD Online Portal, attaching all required documents and test reports.

Step 5: Audit by Notified Body

A notified body, selected from the list of notified bodies, conducts an audit of your manufacturing facility and quality systems.

Step 6: Resolution of Queries

Address any queries or observations raised by the CDSCO or the notified body promptly to avoid delays.

Step 7: Grant of Manufacturing License (Form MD5)

Upon successful audit and document evaluation, the State Licensing Authority grants the MD5 manufacturing license.

Manufacturing License Documents Required for Class B Dental Devices

Company Constitution (e.g., MOA, AOA)
Proof of Ownership or Lease Agreement of Manufacturing Premises
Details and Qualifications of Technical Staff
Fire NOC and Pollution Control Board NOC
Device Master File (DMF) detailing product specifications and formulation (Device Master File Guide)
Plant Master File (PMF) describing manufacturing processes and facilities (Plant Master File Guide)
Essential Principles Checklist ensuring compliance with MDR 2017
Risk Management File documenting identified risks and mitigations (Risk Management)
Test Reports from government-approved labs
Product Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Root Canal Filling Removal Solution

If you are an importer rather than a manufacturer, the MD15 import license is mandatory. This license is issued by the Central Licensing Authority.

Key Steps:

Prepare all required documents, including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Submit the application using Form MD14 through the CDSCO MD Online Portal.
Respond promptly to any queries raised by CDSCO.
Await license grant on Form MD15.

The import license process typically takes 5-6 months.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Certificate
CE Certificate or equivalent
Device Master File
Plant Master File
Wholesale License
Company Constitution

Timeline and Processing Duration for Class B Root Canal Filling Removal Solution

Process Step	Duration
Test License (MD13)	1.5 - 2 months
Product Testing	1 - 1.5 months
Documentation Prep	Concurrent
License Application (MD5)	Immediate after docs
Notified Body Audit	1 month
Query Resolution	2 - 4 weeks
Total Estimated Time	3 - 4 months

Planning ahead and simultaneous preparation of documentation and testing can accelerate the overall timeline.

Government Fees and Costs for MD5 License

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

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

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

Solution: Engage with CDSCO-approved labs early and schedule testing slots in advance.

Challenge 2: Incomplete Documentation

Solution: Use our detailed checklists and templates to ensure all documents like DMF, PMF, and Risk Management files are comprehensive.

Challenge 3: Audit Non-compliance

Solution: Pre-audit your facility with experts to identify gaps before notified body visits.

Challenge 4: Query Resolution Delays

Solution: Assign a dedicated regulatory liaison to respond promptly and clearly to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing process for a specialized product like Root Canal Filling Removal Solution requires meticulous attention to detail and regulatory expertise. With over 25 years of experience and a portfolio of 500+ successful approvals, we offer:

Tailored regulatory strategy and gap analysis
Document preparation and review
Coordination with testing laboratories and notified bodies
End-to-end application management

Our team ensures a smooth, cost-effective journey to market authorization.

Getting Started with Your CDSCO License Application

Classify your device precisely using the Medical Device Classification guide to confirm Class B status.
Register an account on the CDSCO MD Online Portal.
Apply for the Test License (Form MD13) to start product manufacturing for testing.
Schedule testing at government-approved labs.
Prepare required documentation such as Device Master File and Plant Master File concurrently.
Submit MD5 license application (Form MD3) once testing and document preparation are complete.
Prepare for and coordinate the notified body audit.
Respond to queries promptly to avoid delays.

By following these actionable steps and leveraging expert support, manufacturers and importers can successfully obtain the CDSCO license for Root Canal Filling Removal Solution and confidently enter the Indian dental device market.