CDSCO License for Dental material mixing surface, single-use
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
It has pad or tray used to knead or mix dental material (impression material, cement, etc).
Introduction to Dental Material Mixing Surface (Single-Use) and Regulatory Importance
Dental material mixing surfaces, single-use pads or trays, play a crucial role in ensuring precise mixing of impression materials, cements, and other dental substances. Classified under Class A risk by CDSCO, these devices are considered low risk but still require strict regulatory compliance to guarantee safety and efficacy. As experienced regulatory consultants with over 25 years and 500+ successful client licenses, we understand the nuances of obtaining CDSCO approvals, enabling manufacturers and importers to navigate the Indian market seamlessly.
CDSCO Regulatory Framework for Class A Dental Devices
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Your single-use dental material mixing surface, notified under 29/Misc./03/2020-DC (140) Part-5 on 10.10.2022, falls in Class A (low risk) category. This classification dictates the licensing pathway, quality standards, and audit requirements specific to your product.
Risk Classification and License Requirements for Dental Mixing Surfaces
Class A devices like dental material mixing surfaces require an MD5 Manufacturing License granted by the State Licensing Authority. This license ensures your manufacturing processes, facility, and quality systems comply with Indian regulations. The MD5 process includes obtaining a Test License (Form MD13) first, followed by product testing and audit by a notified body.
Understanding this classification upfront prevents regulatory delays and aligns your compliance roadmap efficiently. For detailed classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Class A Dental Devices
The MD5 license process involves several critical steps:
- Apply for Test License (MD13): Initial permission to manufacture for testing purposes, taking approximately 1.5 to 2 months.
- Product Testing: Conducted at CDSCO-approved testing laboratories to verify compliance with essential principles.
- Document Preparation: Compile Device Master File, Plant Master File, Risk Management File, and other required documents.
- Submit License Application (Form MD3) for MD5: Apply through the CDSCO MD Online Portal.
- Audit by Notified Body: A mandatory inspection of manufacturing premises and quality systems.
- Query Resolution: Address any observations raised by the licensing authority or notified body.
- Grant of License (Form MD5): Official approval to manufacture and market the device in India.
For a comprehensive walkthrough, see our detailed MD5 License Guide.
Manufacturing License Documents Required for Dental Material Mixing Surfaces
Accurate and thorough document submission is key to smooth approval:
- Company Constitution Documents: Incorporation certificate, partnership deed, etc.
- Proof of Premises Ownership or Lease Agreement
- Details of Technical Personnel: Qualifications and experience of key staff.
- Fire NOC and Pollution Control NOC
- Device Master File: Detailed technical and design specifications. Our Device Master File guide can assist.
- Plant Master File: Manufacturing processes, quality control. Learn more in our Plant Master File guide.
- Essential Principles Checklist: Compliance with safety and performance requirements.
- Risk Management File: Risk analysis and mitigation strategies. Refer to our Risk Management resource.
- Test Reports: From CDSCO-approved labs.
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: ISO 13485 certification or equivalent.
Ensuring all documents are current, precise, and tailored to the dental mixing surface device significantly reduces review cycles.
Import License Process (MD15) for Dental Devices
If you plan to import this device, you must obtain an MD15 Import License from the Central Licensing Authority. The process includes:
- Document compilation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate.
- Application submission on the CDSCO MD Online Portal.
- Query resolution and eventual grant of license.
The import license timeline is typically 5-6 months. For specific guidance, our Import License Guide is an excellent resource.
Import License Documents Required
Key documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale Drug License
- Company Constitution
Meticulous document preparation helps avoid costly delays.
Timeline and Processing Duration for MD5 License
For Class A dental material mixing surfaces, here is the typical timeline:
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| License Application (MD3) Submission | Immediate after testing |
| Audit by Notified Body | 3 to 4 weeks |
| Query Resolution | 2 to 3 weeks |
| Grant of MD5 License | Total ~3 to 4 months |
Being proactive in document completeness and timely responses can help adhere to these timelines strictly.
Government Fees and Costs for Class A Dental Devices
The fee structure for MD5 licensing is transparent:
- Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500 per product
Additional costs include testing fees charged by government-approved labs and audit charges by notified bodies. Budgeting for these early avoids surprises.
Common Challenges and Solutions in CDSCO Licensing
- Incomplete Documentation: Leads to prolonged queries. Solution: Use detailed checklists and expert reviews.
- Delayed Testing Reports: Coordinate with CDSCO-approved labs well in advance. Check Testing Laboratories list.
- Audit Non-compliance: Ensure your QMS and manufacturing practices align with MDR 2017 and notified body guidelines.
- Regulatory Updates: Stay current with notifications like 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.
We recommend early engagement with notified bodies from the CDSCO notified bodies list to understand audit expectations.
Expert Consultation and Support
With over 25 years of expertise and a track record of assisting 500+ companies, we offer tailored consulting for:
- Gap analysis and document preparation
- Regulatory strategy for Class A dental devices
- End-to-end application management on the CDSCO MD Online Portal
- Training on quality systems and risk management
Our practical insights reduce approval cycles and accelerate your Indian market entry.
Getting Started with Your CDSCO License Application
- Assess your device classification: Confirm Class A status based on latest CDSCO notifications.
- Prepare documentation: Begin compiling your Device Master File, Plant Master File, risk and QMS documents.
- Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
- Coordinate Testing: Engage CDSCO-approved labs early to schedule product testing.
- Plan for Audit: Contact a notified body to schedule the MD5 audit post-testing.
- Submit License Application (Form MD3): Upon successful testing and audit readiness.
- Respond Promptly to Queries: Expedite resolution to avoid delays.
Starting early and leveraging expert guidance ensures a smooth regulatory journey for your single-use dental material mixing surface. Contact us today to discuss how we can assist you in obtaining your CDSCO MD5 license effectively and efficiently.
