CDSCO License for Dental Varnishes/ Glazing

Comprehensive Guide to CDSCO Licensing for Dental Varnishes/Glazing Devices (Class B)

Navigating the regulatory landscape for medical devices in India can be complex, especially for dental devices like Dental Varnishes/Glazing. These devices, intended to provide a smooth, glaze-like finish on restorative dental fillings, fall under Risk Class B per CDSCO’s notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. With over 25 years of experience supporting 500+ companies, we provide you with a detailed, step-by-step roadmap for obtaining your CDSCO MD5 manufacturing license, essential for legally marketing your product in India.

CDSCO Regulatory Framework for Dental Varnishes/Glazing Devices

Dental Varnishes/Glazing devices are regulated under the Medical Device Rules (MDR) 2017, enforced by the Central Drugs Standard Control Organization (CDSCO). As per the latest notification, these devices are classified as Class B, indicating a low to moderate risk profile. This classification necessitates compliance with essential principles and obtaining a manufacturing license from the State Licensing Authority.

Risk Classification and License Requirements

Class B devices, including Dental Varnishes/Glazing, require the MD5 license issued by the State Licensing Authority. This license process ensures your device meets safety, quality, and performance standards, including adherence to Good Manufacturing Practices (GMP).

• Risk Class: B
• License Type: MD5 (Form MD3 application)
• Issuing Authority: State Licensing Authority
• Approximate Timeline: 3 to 4 months
• Applicable Regulations: Medical Device Rules 2017 and subsequent CDSCO notifications

Manufacturing License Process (MD5) for Dental Varnishes/Glazing

The MD5 licensing process is methodical and involves several critical phases:

1. Test License (Form MD13): Initially, you must obtain a test license to manufacture the device samples for testing. This phase typically takes 1.5 to 2 months.

2. Product Testing: Your dental varnish must be tested at CDSCO-approved laboratories to validate compliance with technical specifications. You can find the list of approved testing laboratories here.

3. Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: Submit your application using Form MD3 on the CDSCO MD Online Portal for the MD5 license.

5. Audit by Notified Body: An audit of your manufacturing facility and QMS will be conducted by a notified body. You can consult the list of notified bodies here.

6. Query Resolution: Address any observations or queries raised by the authorities or notified body promptly to avoid delays.

7. Grant of License: Upon successful audit and document review, the MD5 license is granted (Form MD5).

Manufacturing License Documents Required

For Dental Varnishes/Glazing devices, meticulous documentation is crucial. The following are mandatory:

• Company Constitution (Certificate of Incorporation/Partnership Deed)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualifications and Experience Certificates of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) – detailing design, specifications, and manufacturing process (Learn more on DMF preparation)
• Plant Master File (PMF) – outlining your manufacturing environment and controls (PMF guide here)
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management insights)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents as per ISO 13485 standards

Import License Process (MD15) for Dental Varnishes/Glazing

If you plan to import Dental Varnishes/Glazing devices, an MD15 import license issued by the Central Licensing Authority is mandatory. The process is as follows:

• Compile necessary documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, Wholesale license, and Company Constitution.
• Submit application on the CDSCO MD Online Portal using Form MD14.
• Address any queries raised by the department.
• License issuance typically takes 5 to 6 months.

Import License Documents Required

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

Timeline and Processing Duration

Total Duration: Approximately 3 to 4 months

Government Fees and Costs

• Test License (MD13): Included in application fees
• MD5 License Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Note: Additional costs for testing, notified body audit, and consultancy may apply.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited slots at government-approved labs.

Solution: Plan testing early, consider alternate CDSCO-approved labs, and maintain open communication with testing authorities.

Challenge: Incomplete or inconsistent documentation leading to audit observations.

Solution: Engage with experienced consultants familiar with CDSCO requirements to ensure thorough and compliant documentation.

Challenge: Audit non-conformities related to QMS or manufacturing premises.

Solution: Conduct internal audits and mock inspections before official audits.

Expert Consultation and Support

With our extensive track record in securing CDSCO approvals for dental and other medical devices, we offer tailored regulatory consulting, document preparation, and audit readiness support. Our expert team ensures your Dental Varnishes/Glazing device meets all regulatory expectations, minimizing delays and risks.

Getting Started with Your CDSCO License Application

1. Assess Classification: Confirm your device’s classification as Class B.
2. Prepare Documentation: Start compiling critical documents, including DMF and PMF.
3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal.
4. Schedule Product Testing: Book slots at a CDSCO-approved laboratory.
5. Plan Facility Audit: Coordinate with a notified body early, referencing the notified bodies list.
6. Submit MD5 Application: After successful testing and documentation, apply via Form MD3.
7. Prepare for Queries: Be ready to respond promptly to any observations.

Taking these practical steps with expert guidance will greatly enhance your chances of a smooth and timely CDSCO licensing process. For personalized support tailored to your Dental Varnishes/Glazing device, contact us today and leverage our 25+ years of regulatory expertise.