CDSCO License for Dental Cleansing Solution

Comprehensive Guide to CDSCO Licensing for Dental Cleansing Solution (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies in securing their CDSCO licenses, we understand the critical nuances involved in bringing specialized medical devices like Dental Cleansing Solutions to the Indian market. This article provides a thorough overview and actionable insights to help manufacturers and importers navigate the CDSCO licensing process for this Class B dental device.

Introduction: Dental Cleansing Solution and Regulatory Importance

Dental Cleansing Solutions are essential liquid formulations used during endodontic procedures to clean and disinfect root canals or cavities after preparation. Classified under the dental category and notified under 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, this device falls under Risk Class B according to CDSCO classification. Given its direct application in patient care and infection control, regulatory compliance is paramount to ensure safety, efficacy, and market authorization in India.

CDSCO Regulatory Framework for Dental Cleansing Solution

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. For Class B devices like Dental Cleansing Solutions, manufacturers must obtain the MD5 manufacturing license from the State Licensing Authority. Importers require the MD15 import license issued by the Central Licensing Authority. The regulatory framework mandates conformity to Indian Medical Device Rules, 2017, including provisions for device testing, documentation, quality management, and audits.

Risk Classification and License Requirements

Dental Cleansing Solutions are classified as Class B devices due to their moderate risk profile involving direct contact with internal body sites during dental procedures.

• Manufacturing License: MD5 License (Application Form MD3) issued by the State Authority
• Import License: MD15 License (Application Form MD14) issued by the Central Authority

For detailed classification guidance, consult our Medical Device Classification resource.

Manufacturing License Process (MD5) for Class B Devices

Obtaining an MD5 license is a multi-step process typically spanning 3-4 months. Here’s the practical workflow:

1. Application for Test License (Form MD13): Initiate the process by applying for a test license valid for 90 days, allowing sample testing of the Dental Cleansing Solution in government-approved labs. This step usually takes 1.5-2 months.
2. Product Testing: Submit product samples to CDSCO-recognized labs. Refer to the Testing Laboratories list for approved facilities.
3. Document Preparation: Compile all mandatory documents including Device Master File, Plant Master File, Quality Management System (QMS) records, and risk management files.
4. Application for MD5 License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct a detailed audit of your manufacturing premises and QMS. Access the List of Notified Bodies for audit partners.
6. Resolution of Queries: Address any departmental or notified body queries promptly to avoid delays.
7. Grant of MD5 License: Upon successful audit and document verification, the State Licensing Authority issues the MD5 license (Form MD5).

Manufacturing License Documents Required

Key documents essential for the MD5 license application include:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Qualifications and Experience Details of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing formulation, manufacturing process, and specifications. Our comprehensive Device Master File guide explains this in detail.
• Plant Master File (PMF) describing manufacturing site and facilities. See our Plant Master File guide for best practices.
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating hazard identification and mitigation, following risk management principles
• Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (preferably ISO 13485:2016 certified)

Import License Process (MD15) for Dental Cleansing Solution

If you intend to import Dental Cleansing Solutions into India, obtaining an MD15 license from CDSCO’s Central Licensing Authority is mandatory. The process generally takes 5-6 months and includes:

1. Document Preparation: Prepare comprehensive documentation, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, Wholesale License (if applicable), and company constitution.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond to any queries or requests for additional information from CDSCO.
4. Grant of MD15 License: Upon satisfactory review, the import license is granted.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Mark Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Proactive planning and early document preparation can significantly reduce processing times.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License: Fees vary by device class; for Class B devices, approximately $2,000 per site and$1,000 per product (USD equivalent)

These fees exclude costs for product testing, notified body audits, and consultancy services.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or inadequate risk management.

Solution: Engage experienced consultants early to prepare robust Device Master Files and Risk Management documentation, minimizing back-and-forth with CDSCO.

Challenge: Difficulty in scheduling audits with notified bodies.

Solution: Select notified bodies from the official List of Notified Bodies well in advance and coordinate timelines.

Challenge: Extended product testing durations.

Solution: Use government-approved labs listed on the Testing Laboratories page and submit samples promptly.

Expert Consultation and Support

With over 25 years of expertise and a track record of successfully facilitating CDSCO approvals for over 500 companies, we provide end-to-end support:

• Tailored gap analysis for your manufacturing or import setup
• Comprehensive documentation and regulatory dossier preparation
• Coordination with notified bodies and testing laboratories
• Strategic project management to ensure timely license grant

Our proactive approach helps mitigate risks, streamline compliance, and accelerate your time-to-market.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm that Dental Cleansing Solution is Class B.
2. Initiate Test License Application: Apply for MD13 test license using the CDSCO MD Online Portal.
3. Prepare Documentation: Start compiling your Device Master File, Plant Master File, and risk management files.
4. Plan Product Testing: Select an approved testing laboratory and schedule sample submission.
5. Engage Notified Body: Identify a notified body early to align audit timelines.
6. Maintain Communication: Monitor application status and resolve queries proactively.

Embarking on the CDSCO licensing journey for your Dental Cleansing Solution is complex but manageable with expert guidance and meticulous preparation. Contact us today to leverage our proven methodologies and ensure your product reaches Indian healthcare providers swiftly and compliantly.