CDSCO License for Dental endodontic enlarger

Comprehensive CDSCO Licensing Guide for Dental Endodontic Enlarger (Class B Medical Device)

Dental endodontic enlargers serve a critical role in root canal therapy by enlarging, probing, and cleaning root canals through various mechanical motions such as vibrating, rotating, and reciprocating. Given their significant clinical impact and moderate risk profile, these devices fall under Class B risk classification as per CDSCO regulations (Notification No. 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022). Navigating the regulatory landscape effectively is essential for manufacturers and importers targeting the Indian market.

With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide a detailed roadmap tailored for Dental Endodontic Enlargers to ensure smooth regulatory approval.

CDSCO Regulatory Framework for Dental Endodontic Enlargers

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Dental devices such as endodontic enlargers are categorized under the dental device section. According to the latest notification, these devices are classified as Class B due to their moderate risk level.

Class B devices require a manufacturing license under the MD5 category, granted by the State Licensing Authority. Compliance with the essential principles of safety and performance, along with thorough documentation and testing, is mandatory before license issuance.

For detailed device classification, refer to our Medical Device Classification guide.

Risk Classification and License Requirements for Dental Endodontic Enlarger

• Risk Class: B (Moderate Risk)
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license; MD13 for test license

The MD5 license process involves obtaining a test license (MD13), conducting product testing at government-approved laboratories, preparing comprehensive documentation, and undergoing audit by a notified body.

You can check the list of notified bodies authorized to conduct audits.

Manufacturing License Process (MD5) for Class B Dental Devices

1. Apply for Test License (MD13):

   • Submit application through the CDSCO MD Online Portal.
   • Processing time: Approximately 1.5 to 2 months.
   • Purpose: To legally manufacture samples for testing.

2. Product Testing:

   • Get the Dental Endodontic Enlarger tested at a CDSCO-approved laboratory. Check the Testing Laboratories list.
   • Testing includes safety, performance, and compliance with essential principles.

3. Documentation Preparation:

   • Prepare Device Master File, Plant Master File, Risk Management File, and other required documents.
   • Utilize our Device Master File guide and Plant Master File guide for comprehensive preparation.

4. Submit Manufacturing License Application (MD3):

   • File the application on the CDSCO portal.
   • Include test reports, audit reports, and all supporting documents.

5. Audit by Notified Body:

   • An audit of the manufacturing facility is conducted to evaluate compliance.

6. Queries Resolution:

   • Address any queries raised by CDSCO or the notified body promptly.

7. License Grant:

   • Upon satisfactory compliance, the MD5 license is issued.

Manufacturing License Documents Required for Dental Endodontic Enlarger

• Company Constitution Documents (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC from the local fire department
• Pollution Control Board NOC
• Device Master File (DMF) describing design, specifications, and manufacturing processes
• Plant Master File (PMF) detailing the facility and quality management system
• Essential Principles Compliance Checklist
• Risk Management File (following ISO 14971 principles)
• Product Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification is beneficial)

Properly compiling these documents significantly reduces processing delays. Our experts can assist in preparing these files to meet CDSCO’s stringent requirements.

Import License Process (MD15) for Dental Endodontic Enlarger

For importers, the process differs as MD15 licenses are issued by the Central Licensing Authority with a longer timeline of approximately 5-6 months.

Steps include:

1. Document preparation (including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate).
2. Application submission on CDSCO MD Online Portal using Form MD14.
3. Queries resolution.
4. License grant (Form MD15).

For detailed guidance, refer to our Import License guide.

Timeline and Processing Duration

Total time for MD5 manufacturing license (Class B Dental Endodontic Enlarger): ~3 to 4 months.

Planning each phase meticulously, especially testing and audit readiness, helps prevent unexpected delays.

Government Fees and Costs

• Application Fee for MD5 Manufacturing License: INR 5,000 per application.
• Product Fee: INR 500 per product.

Additional costs to budget:

• Laboratory testing fees (varies by test scope and lab).
• Audit fees charged by the notified body.
• Consultancy fees if external assistance is engaged.

Investing in expert consultancy can expedite approvals and avoid costly mistakes.

Common Challenges and Practical Solutions

Challenge 1: Delay in Test License Approval

• Solution: Submit a complete and error-free MD13 application with all supporting documents upfront. Track status regularly on the CDSCO portal.

Challenge 2: Non-compliance in Product Testing

• Solution: Conduct pre-testing through accredited private labs to identify issues before sending samples to government labs.

Challenge 3: Audit Non-conformities

• Solution: Perform internal audits and mock inspections prior to notified body visits. Ensure staff training and QMS adherence.

Challenge 4: Incomplete Documentation

• Solution: Use checklists and professional guidance to prepare comprehensive Device and Plant Master Files, Risk Management files, and Essential Principles checklists.

Challenge 5: Queries from CDSCO

• Solution: Respond promptly and clearly with evidence-based explanations. Maintain a dedicated team or consultant for regulatory communication.

Expert Consultation and Support

Navigating the CDSCO licensing process for dental medical devices demands specialized knowledge and experience. Our team has successfully guided over 500 companies through MD5 licensing, ensuring compliance and faster approvals.

We offer:

• Detailed gap analysis of your current compliance status.
• End-to-end document preparation and review.
• Coordination with testing laboratories and notified bodies.
• Pre-audit readiness assessments.
• Prompt handling of CDSCO queries.

Partner with us to leverage our deep regulatory expertise and industry insights.

Getting Started with Your CDSCO License Application for Dental Endodontic Enlarger

1. Assess Your Device Classification: Confirm Class B status and licensing pathway.
2. Register on CDSCO MD Online Portal: Create your account to access application forms.
3. Apply for Test License (MD13): Compile required documents and submit.
4. Plan for Product Testing: Schedule tests with approved labs.
5. Prepare Documentation: Start assembling Device Master File, Plant Master File, and Risk Management File concurrently.
6. Engage a Notified Body: Identify and appoint a notified body from the official list early.
7. Schedule Audit: Coordinate audit dates to align with testing completion.
8. Maintain Open Communication: Respond to CDSCO queries promptly via the portal.

By following this structured approach and leveraging expert guidance, you can successfully obtain your MD5 manufacturing license for Dental Endodontic Enlargers and enter the vibrant Indian medical device market with confidence.

For personalized assistance, connect with our regulatory consultants to kickstart your CDSCO license journey today.