CDSCO License for Dental polishing brush

Introduction: Understanding the Dental Polishing Brush and Its Regulatory Significance

The dental polishing brush is a Class A medical device designed as a rotary brush for cleaning and polishing teeth, primarily used by dental hygienists and dentists. Classified under the dental category with notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, this device requires compliance with the Central Drugs Standard Control Organization (CDSCO) regulations before it can be manufactured or imported for sale in India.

Given its intended use in oral hygiene and its classification as a low-risk device, obtaining the correct CDSCO license is essential not only for legal market entry but also for ensuring patient safety and quality standards. With over 25 years of experience and having supported 500+ companies in navigating CDSCO processes, we provide you with a detailed roadmap tailored specifically for dental polishing brushes.

CDSCO Regulatory Framework for Dental Polishing Brushes

In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. The dental polishing brush falls under Class A, the lowest risk category, thus requiring an MD5 manufacturing license issued by the State Licensing Authority.

Manufacturers must first obtain a test license (Form MD13) before applying for the manufacturing license (Form MD3). Importers, on the other hand, require an MD15 import license from the Central Licensing Authority, but since this guide focuses on manufacturing, we concentrate on the MD5 licensing pathway.

Risk Classification and License Requirements for Class A Devices

Class A devices like the dental polishing brush are considered low risk and are subject to streamlined regulatory controls relative to higher classes. The risk classification dictates that manufacturers must obtain an MD5 license from the State Authority, involving:

• Test License on Form MD13
• Product testing from CDSCO-approved laboratories
• Audit by a notified body
• Submission of comprehensive technical and quality documents

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

Manufacturing License Process (MD5) for Dental Polishing Brush

Step 1: Apply for Test License (Form MD13)

Before applying for the manufacturing license, you must secure a test license to produce samples for testing. This takes approximately 1.5 to 2 months.

Step 2: Product Testing

The dental polishing brush must undergo testing at CDSCO-approved laboratories to confirm compliance with essential principles. You can find the list of authorized testing laboratories here.

Step 3: Documentation Preparation

Prepare all required documents including Device Master File, Plant Master File, risk management files, and quality management system (QMS) documentation.

Step 4: Application Submission (Form MD3)

Submit your application through the CDSCO MD Online Portal, attaching all relevant documents.

Step 5: Audit by Notified Body

A notified body will conduct an audit of your manufacturing facility. You can check the list of notified bodies authorized for this audit.

Step 6: Query Resolution

Respond promptly to any queries raised during the audit or review process.

Step 7: Grant of License (Form MD5)

Upon successful completion of all steps, the State Licensing Authority will grant the MD5 manufacturing license.

Manufacturing License Documents Required

For a dental polishing brush, the following documents must be meticulously prepared and submitted:

• Company Constitution (Incorporation certificate, Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC (if applicable)
• Device Master File (DMF) detailing device specifications and design (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing processes (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File specific to device hazards and mitigations (Risk Management)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 certification recommended)

Proper preparation of these documents significantly reduces back-and-forth with CDSCO, expediting approval.

Import License Process (MD15) for Dental Polishing Brush

While not mandatory for manufacturers, importers of dental polishing brushes must apply for an MD15 import license granted by the Central Licensing Authority. The process takes approximately 5 to 6 months and requires:

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

The import license application is submitted on the CDSCO MD Online Portal.

For detailed guidance, refer to our comprehensive Import License Guide.

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months.

Government Fees and Costs

• Test License (MD13): Included in application fees
• MD5 Manufacturing License:
  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

For example, if applying for manufacturing 3 variants of the dental polishing brush, total fees would be Rs 5,000 + (3 x Rs 500) = Rs 6,500.

Additional costs may include laboratory testing fees, notified body audit charges, and consultancy fees if availed.

Common Challenges and Solutions

Challenge: Delay due to incomplete documentation

Solution: Utilize checklists and templates for Device Master File and Plant Master File as per CDSCO requirements.

Challenge: Difficulty in scheduling notified body audits

Solution: Early engagement with notified bodies, referencing the list of notified bodies to select those with shorter lead times.

Challenge: Product testing failures or non-compliance

Solution: Conduct pre-submission testing through third-party labs and implement robust risk management strategies.

Challenge: Ambiguous queries from CDSCO

Solution: Seek expert consultation to draft precise responses and ensure alignment with regulatory expectations.

Expert Consultation and Support

With our extensive experience assisting over 500 companies in medical device licensing, we provide end-to-end support encompassing:

• Gap analysis for documentation and QMS
• Device Master File and Plant Master File preparation
• Liaison with notified bodies and testing labs
• Application submission and follow-up
• Training on regulatory compliance and post-market surveillance

Partnering with experts significantly reduces approval timelines and enhances compliance integrity.

Getting Started with Your CDSCO License Application for Dental Polishing Brush

1. Assess your device classification and confirm that your dental polishing brush is Class A under CDSCO regulations.
2. Gather all technical and quality documents, starting with company incorporation papers and device specifications.
3. Plan test license application (Form MD13) and initiate sample production.
4. Identify and engage with a notified body early to schedule your audit.
5. Submit your test license and manufacturing license applications through the CDSCO MD Online Portal to ensure timely processing.
6. Prepare for product testing at government-approved labs.
7. Respond promptly to CDSCO queries to avoid delays.

Starting early and maintaining proactive communication with CDSCO authorities and notified bodies is key to a smooth licensing journey.

For step-by-step details on the MD5 license process, you can explore our MD5 License Guide.

Embarking on your CDSCO licensing journey with the right information and support ensures your dental polishing brush reaches the Indian market efficiently and compliantly. Contact us to leverage our expertise and streamline your regulatory pathway.