CDSCO License for Endodontic Sealer

Comprehensive Guide to CDSCO Licensing for Endodontic Sealer (Class B Medical Device)

As a critical component in dental care, the Endodontic Sealer plays a vital role in root canal therapy by filling and sealing pathways between the root canal and external tooth surfaces. Classified as a Class B medical device under the CDSCO regulatory framework, it demands thorough compliance to ensure safety, efficacy, and quality before entering the Indian market.

With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we provide a detailed, step-by-step roadmap tailored specifically for Endodontic Sealers. This guide covers regulatory requirements, timelines, costs, and practical tips to help manufacturers and importers avoid common pitfalls.

CDSCO Regulatory Framework for Dental Devices: Endodontic Sealer

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India, with specific mandates for dental devices like the Endodontic Sealer. As per the notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, this device falls under Class B.

Class B devices require a manufacturing license from the State Licensing Authority, typically under the MD5 license regime, which involves a combination of documentation, product testing, and audits.

Risk Classification and License Requirements for Endodontic Sealer

The Endodontic Sealer is classified as a Class B device due to its moderate risk profile — it is invasive but limited in duration and scope.

• License Type: MD5 (Manufacturing License for Class A and B devices)
• Regulatory Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license
• Test License Form: MD13 (mandatory before MD5 application)

For importers, the MD15 license from the Central Licensing Authority applies.

Manufacturing License Process (MD5) for Endodontic Sealer

Obtaining an MD5 license for a Class B device like the Endodontic Sealer involves the following sequential steps:

1. Apply for Test License (Form MD13): This initial step takes approximately 1.5 to 2 months. The test license permits you to manufacture sample batches for testing.

2. Product Testing: Samples must be tested in CDSCO-approved laboratories to verify compliance with prescribed standards. Testing duration varies but typically takes 4 to 6 weeks.

3. Document Preparation: Simultaneously, prepare comprehensive documents such as the Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.

4. Apply for Manufacturing License (Form MD3): Submit the full application with supporting documents on the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body from the official list of notified bodies to evaluate compliance with Good Manufacturing Practices (GMP) and QMS.

6. Address Queries: Respond promptly to any queries raised by the State Licensing Authority or the notified body.

7. Grant of License (Form MD5): Upon satisfactory review, the manufacturing license is granted.

This process generally spans 3 to 4 months from start to finish.

Manufacturing License Documents Required

For the Endodontic Sealer, the following documents are essential:

• Company Constitution (Memorandum and Articles of Association)
• Proof of ownership or lease of manufacturing premises
• List and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed product specifications, formulation, manufacturing processes; refer to our Device Master File guide
• Plant Master File (PMF): Details of the manufacturing facility; see our Plant Master File guide
• Essential Principles Checklist
• Risk Management File (per ISO 14971 standards); practical insights available in our Risk Management guide
• Product Test Reports from CDSCO-approved labs (list here)
• Product labels and Instructions for Use (IFU)
• Quality Management System documents, preferably ISO 13485:2016 certified

Import License Process (MD15) for Endodontic Sealer

Importers intending to bring the Endodontic Sealer into India must apply for an MD15 import license granted by the Central Licensing Authority. The process includes:

1. Document Compilation: Prepare documents including existing manufacturing license, Free Sale Certificate (FSC) from the country of origin, ISO 13485:2016 certificate, CE certificate (if applicable), DMF, PMF, and Wholesale License.

2. Application Submission: Submit Form MD14 for import license on the CDSCO MD Online Portal.

3. Review and Queries: Address any queries raised by the CDSCO during the review.

4. Grant of MD15 License: Once cleared, the import license is issued.

The timeline for import license approval typically ranges from 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate (FSC) issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution

Timeline and Processing Duration

Plan your project timelines accordingly, keeping buffer time for audit scheduling and potential query responses.

Government Fees and Costs

For the Endodontic Sealer (Class B device), expect the following fees:

• MD5 Manufacturing License:

  • Rs. 5,000 per application
  • Rs. 500 per product

• Test License (MD13): Usually bundled within the license process, but nominal fees may apply.

• MD15 Import License: (For reference, if applicable)

  • Approximately $2,000 per site
  • $1,000 per product

Budget for additional costs such as notified body audit fees, product testing charges, and documentation preparation.

Common Challenges and Solutions

Challenge: Delays in product testing due to sample rejection or incomplete documentation.

Solution: Ensure thorough documentation and sample preparation before submission. Utilize CDSCO-approved testing labs with experience in dental devices.

Challenge: Audit non-conformities related to GMP or QMS gaps.

Solution: Conduct internal audits and gap assessments prior to notified body audits. Implement corrective actions promptly.

Challenge: Complex documentation requirements and risk management compliance.

Solution: Leverage expert guidance and templates to prepare Device Master File, Plant Master File, and Risk Management File effectively.

Expert Consultation and Support

Navigating the CDSCO licensing process for Endodontic Sealers can be complex but manageable with the right expertise. Our seasoned regulatory consultants provide:

• Tailored documentation support
• Audit readiness evaluations
• Liaison with CDSCO and notified bodies
• Comprehensive project management from test license to final approval

Connect with us to leverage our proven track record in helping manufacturers and importers successfully enter the Indian dental device market.

Getting Started with Your CDSCO License Application for Endodontic Sealer

1. Assess Your Risk Class: Confirm Endodontic Sealer classification as Class B using resources like our Medical Device Classification guide.

2. Register on CDSCO MD Online Portal: Begin your application by registering here.

3. Prepare Test License Application (Form MD13): Gather initial documents and apply to start the testing phase.

4. Select CDSCO-Approved Testing Laboratory: Choose a lab from the official list to conduct product testing.

5. Compile Documentation: Develop your Device Master File, Plant Master File, and Risk Management File concurrently.

6. Plan for Notified Body Audit: Identify and engage a notified body from the official list for your audit.

7. Submit Manufacturing License Application (Form MD3): Upon successful testing and audit readiness.

By following these actionable steps and leveraging expert support, you can streamline your CDSCO licensing journey for the Endodontic Sealer and achieve timely market entry with confidence.