CDSCO License for Dental impression tray, reusable
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A impression tray is a metal or plastic device intended to hold impression material, to make an impression of a patient's teeth to reproduce the structure of a patient's teeth.
Comprehensive Guide to CDSCO Licensing for Reusable Dental Impression Trays (Class A Medical Device)
As specialists with over 25 years of experience and having successfully supported 500+ companies in navigating the Indian medical device regulatory landscape, we understand the critical importance of securing your CDSCO license efficiently and compliantly. This detailed guide focuses on the reusable dental impression tray, a Class A medical device under the Dental category, providing you with practical insights, timelines, fees, and documentation requirements tailored specifically to this product.
Understanding the Reusable Dental Impression Tray and Regulatory Importance
A dental impression tray is a specially designed metal or plastic device used to hold impression materials, enabling accurate reproduction of a patient’s teeth structure. As a reusable device, it demands strict adherence to quality standards and regulatory controls to ensure patient safety and product efficacy. In India, the Central Drugs Standard Control Organization (CDSCO) regulates such devices under the Medical Device Rules (MDR) 2017, making it mandatory to obtain the appropriate license before manufacturing or importing.
CDSCO Regulatory Framework for Dental Impression Trays (Class A)
According to the CDSCO notification dated 10.10.2022 (29/Misc./03/2020-DC (140) Part-5), reusable dental impression trays are classified as Class A low-risk medical devices. This classification places the licensing authority with the State Licensing Authority rather than the central body, streamlining the process but still demanding comprehensive compliance.
For Class A devices, the MD5 manufacturing license (form MD3) is required for domestic manufacturers. This license is critical to legally produce and market your product in India.
Risk Classification and License Requirements for Reusable Dental Impression Trays
| Risk Class | License Type | Licensing Authority | Timeline | Fees |
|---|---|---|---|---|
| Class A | MD5 | State Licensing Authority | 3-4 months | Rs 5,000 + Rs 500 per product |
This classification ensures a focused regulatory approach, emphasizing product safety through testing, documentation, and notified body audit.
Step-by-Step Manufacturing License Process (MD5) for Reusable Dental Impression Trays
Test License Application (Form MD13): The process begins with applying for a test license, which typically takes 1.5 to 2 months. This license allows you to manufacture the product solely for testing purposes.
Product Testing: Post test license approval, your dental trays must undergo testing at government-approved laboratories to validate compliance with applicable standards. You can find a list of approved testing laboratories here.
Documentation Preparation: Concurrently, prepare all necessary documents including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, risk management files, and product labeling.
License Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal along with the required fees.
Notified Body Audit: A notified body will conduct an audit of your manufacturing facility. Check the list of notified bodies to select an appropriate auditor.
Query Resolution: Address any queries raised by the department or the notified body promptly to avoid delays.
License Grant (Form MD5): Once all requirements are satisfactorily met, the State Licensing Authority grants the MD5 license.
Essential Documents Required for MD5 License Application
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire Safety and Pollution Control NOCs
- Device Master File (DMF): Our comprehensive Device Master File guide will help you compile this critical document.
- Plant Master File (PMF): Refer to our Plant Master File Guide for detailed preparation tips.
- Essential Principles Checklist
- Risk Management File: Implementing robust risk management practices is crucial for compliance.
- Test Reports from Government-Approved Labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation (ISO 13485 compliance recommended)
Import License Process (MD15) for Reusable Dental Impression Trays
While our focus is manufacturing, importers intending to bring reusable dental impression trays into India must apply for an MD15 import license. This process takes approximately 5-6 months and requires documents such as a manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, and CE marking.
For detailed guidance, refer to our Import License Guide.
Timeline and Processing Duration for MD5 License
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation Preparation | Concurrent |
| License Application & Audit | 1 - 1.5 months |
| Query Resolution & Final Grant | 0.5 months |
| Total Estimated Time | 3 - 4 months |
Government Fees and Costs
- Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500 for each product (reusable dental impression tray count as one product)
- Testing and Audit Costs: Varies depending on notified body and testing laboratory fees, typically ranging from Rs 50,000 to Rs 1,00,000
Budgeting for these costs early helps avoid surprises and keeps your application on track.
Common Challenges and Practical Solutions
- Delays in Testing: To avoid bottlenecks, schedule testing with government-approved labs early and ensure sample quality.
- Incomplete Documentation: Use our device and plant master file guides to prepare thorough documentation.
- Audit Non-Conformities: Engage experienced notified bodies and conduct internal audits beforehand.
- Query Management: Respond promptly and clearly to regulatory queries to maintain momentum.
Expert Consultation and Support
With our extensive experience assisting over 500 companies, we provide tailored consultancy services including:
- Pre-submission document gap analysis
- Coordination with notified bodies and labs
- Training on regulatory compliance
- End-to-end application management
Our proactive involvement can reduce your licensing timeline by weeks.
Getting Started with Your CDSCO License Application for Dental Impression Trays
- Assess your device classification and confirm MD5 license applicability.
- Initiate your test license application on the CDSCO MD Online Portal.
- Prepare your Device and Plant Master Files in line with regulatory expectations.
- Engage with a notified body early to schedule your audit.
- Plan your product testing with an approved laboratory.
- Compile all required documents and fees for the MD5 license application.
- Submit your manufacturing license application and stay responsive to any queries.
Embarking on this process with expert guidance ensures your reusable dental impression trays reach the Indian market compliantly and efficiently. Contact us to leverage our proven expertise and accelerate your CDSCO licensing journey.
