CDSCO License for Polymer Based Prosthodontic Material
Medical Device Information
Intended Use
Light cured, methacrylate-based resin for creating reservoir space for bleaching trays is useful for laboratory procedures such as model, and die repair. It can be block out defects and under cuts on the stone models quickly and securely for precise abutment preparation.
Comprehensive Guide to CDSCO Licensing for Polymer Based Prosthodontic Material (Class B Dental Device)
As a trusted regulatory consultancy with over 25 years of experience and a proven track record of assisting more than 500 companies, we understand the nuances of navigating the CDSCO regulatory landscape for medical devices in India. This guide focuses on the Polymer Based Prosthodontic Material — a light-cured, methacrylate-based resin used predominantly in dental laboratories for creating reservoir spaces in bleaching trays and precise abutment preparation.
Understanding the Device and Its Regulatory Importance
Polymer Based Prosthodontic Material is classified as a Class B medical device under the latest CDSCO notification [29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022]. Given its intended use in dental applications, ensuring regulatory compliance is critical not only for market access but also for patient safety and quality assurance. The CDSCO mandates a thorough evaluation process to validate manufacturing practices, quality systems, and product safety before granting a license.
CDSCO Regulatory Framework for Polymer Based Prosthodontic Material
This device falls under the Class B risk category, which entails medium risk and stricter regulatory controls compared to Class A devices. As per the CDSCO guidelines, manufacturing such devices requires obtaining an MD5 license from the State Licensing Authority. This license ensures that your manufacturing facility complies with Good Manufacturing Practices (GMP), and the device meets all essential safety, quality, and performance standards.
Risk Classification and License Requirements
- Risk Class: B (Medium Risk)
- License Type: MD5 Manufacturing License
- Authority: State Licensing Authority
- Application Form: MD3
- Testing: Mandatory product testing from CDSCO-approved laboratories
For detailed classification criteria, manufacturers can consult the Medical Device Classification guide.
Step-by-Step Manufacturing License Process (MD5)
- Test License Application (Form MD13): Before applying for the MD5 license, you must first obtain a test license. This allows you to conduct mandatory product testing.
- Product Testing: Submit samples to CDSCO-approved testing laboratories. Check the list of approved testing laboratories to select a suitable lab.
- Document Preparation: Compile all required documents including technical files and quality management system records.
- Application Submission (Form MD3): Submit your formal application for the MD5 manufacturing license via the CDSCO MD Online Portal.
- Notified Body Audit: An audit by a CDSCO-recognized notified body is mandatory. Refer to the notified bodies list for authorized auditors.
- Resolution of Queries: Respond promptly to any queries raised by the regulatory authority or notified body.
- Grant of License (Form MD5): Once compliance is confirmed, the license is granted.
Manufacturing License Documents Required
The documentation package for the Polymer Based Prosthodontic Material must include:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and qualifications of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, composition, and manufacturing processes (see our detailed Device Master File guide)
- Plant Master File describing site details and manufacturing environment (Plant Master File guide)
- Essential Principles Checklist ensuring compliance with Indian standards
- Risk Management File outlining hazard analysis and mitigation (Risk Management overview)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) compliant with regulatory norms
- Quality Management System (QMS) documents, ideally ISO 13485:2016 certified
Import License Process (MD15) for Polymer Based Prosthodontic Material
If you are an importer rather than a manufacturer, you need to apply for an MD15 import license from the Central Licensing Authority. This license requires:
- Valid Manufacturing License of the product in the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device and Plant Master Files
- Wholesale License
- Company Constitution
The application is submitted on the CDSCO MD Online Portal using Form MD14, followed by document review and query resolution, culminating in license grant on Form MD15.
Timeline and Processing Duration
| License Type | Processing Time |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| MD5 Manufacturing License | 3 to 4 months (including audit and test reports) |
Overall, expect a timeline of approximately 3-4 months from test license submission to MD5 license grant.
Government Fees and Costs
- Test License (MD13): Nominal fees (check current rates on CDSCO portal)
- MD5 Manufacturing License:
- Application fee: Rs 5,000
- Per product fee: Rs 500
Additional costs to consider include testing fees payable to laboratories, audit fees charged by notified bodies, and expenses related to document preparation and quality system implementation.
Common Challenges and Solutions
- Delay in Test License Approval: Begin application early and ensure all supporting documents are accurate.
- Product Testing Failures: Partner with experienced labs and conduct pre-testing in-house.
- Audit Non-compliance: Prepare thoroughly with internal audits and gap analysis before notified body inspection.
- Incomplete Documentation: Use document checklists and expert support to avoid back-and-forth with regulators.
Expert Consultation and Support
Navigating CDSCO approvals can be complex. Our consultancy has helped over 500 manufacturers and importers successfully obtain licenses by providing:
- Tailored document preparation
- Pre-audit readiness assessments
- Regulatory strategy and classification advice
- Liaison with CDSCO and notified bodies
Getting Started with Your CDSCO License Application
- Assess your product classification: Confirm the device falls under Class B.
- Initiate test license application (Form MD13): Gather technical files and submit via the CDSCO MD Online Portal.
- Select a CDSCO-approved testing laboratory: Ensure timely sample submission and compliance.
- Prepare comprehensive documentation: Leverage our Device Master File and Plant Master File guides.
- Schedule notified body audit: Choose from the list of notified bodies and prepare your facility.
- Submit MD5 license application (Form MD3): After successful testing and audit.
- Engage with queries promptly: Expedite approvals by addressing all regulatory feedback.
By following these practical steps and leveraging expert support, manufacturers of Polymer Based Prosthodontic Material can confidently achieve CDSCO compliance and access the expanding Indian dental device market.
For personalized assistance and to ensure a smooth licensing journey, connect with our regulatory experts today.
