CDSCO License for Dental crown/bridge, temporary
Medical Device Information
Intended Use
Intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
Comprehensive Guide to CDSCO Licensing for Temporary Dental Crown/Bridge (Class B Medical Device)
As specialists with over 25 years of experience in medical device regulatory consulting, having assisted more than 500 companies, we present an in-depth resource on obtaining CDSCO licensing for Dental Crown/Bridge, Temporary devices. Classified as a Class B medical device under CDSCO regulations, these devices are intended to serve as provisional prosthetics until permanent restorations are fabricated. Navigating the Indian regulatory landscape can be complex, but with clear guidance on timelines, documentation, and costs, manufacturers and importers can streamline their market entry effectively.
CDSCO Regulatory Framework for Temporary Dental Crown/Bridge
Temporary dental crowns and bridges fall under the dental device category and are regulated by the Central Drugs Standard Control Organization (CDSCO) according to the notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. As a Class B device, the regulatory process mandates adherence to the Medical Device Rules (MDR) 2017 and subsequent amendments. The licensing authority is the State Licensing Authority (SLA), and the applicable manufacturing license form is MD5.
Risk Classification and License Requirements
Based on the intended use and risk profile, a temporary dental crown/bridge is classified as a Class B medical device. This classification entails moderate risk, requiring manufacturers to obtain an MD5 Manufacturing License and comply with relevant quality management and safety standards.
Key points:
- License Type: MD5 (Form MD3 for application, Form MD5 for license grant)
- Licensing Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months
- Fees: Rs 5000 per application + Rs 500 per product
For more detailed classification insights, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Temporary Dental Crown/Bridge
The MD5 license process encompasses several stages:
Test License (Form MD13): Before applying for the manufacturing license, applicants must obtain a test license to manufacture and test the device prototype. This typically takes 1.5 to 2 months.
Product Testing: Conduct testing of the dental crown/bridge samples at CDSCO-approved laboratories to validate compliance with Indian standards. A list of Testing Laboratories is available for reference.
Document Preparation: Compile comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, Essential Principles Checklist, and Risk Management File.
Application Submission: Submit the manufacturing license application (Form MD3) via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will audit your manufacturing facility for compliance. Check the list of notified bodies authorized for MD5 audits.
Query Resolution: Address any queries raised by the CDSCO or notified body promptly.
License Grant: Upon satisfactory audit and documentation, the license is granted on Form MD5.
Our detailed MD5 License Guide offers step-by-step assistance.
Manufacturing License Documents Required
For temporary dental crown/bridge manufacturers, the following documents are essential:
- Company Constitution (Incorporation Certificate, Memorandum of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Documents of Qualified Technical Staff (Educational qualifications, experience)
- Fire NOC and Pollution Control Board NOC
- Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
- Plant Master File describing the manufacturing site and processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File demonstrating hazard identification and mitigation (Risk Management)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) complying with labeling regulations
- Quality Management System Documents (ISO 13485:2016 certification recommended)
Import License Process (MD15) for Temporary Dental Crown/Bridge
If you are an importer of temporary dental crowns/bridges, you must apply for an MD15 Import License through the CDSCO Central Licensing Authority. The process includes:
- Preparation of required documents, including valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and related files.
- Submission of license application on the CDSCO MD Online Portal.
- Resolution of queries raised by the department.
- Grant of Import License (Form MD15).
The import license process typically takes 5-6 months. For detailed guidance, see our Import License Guide.
Import License Documents Required
- Valid Manufacturing License of the product in the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution documents
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 3 weeks |
| Document Preparation | 3 - 4 weeks |
| Application Submission | Immediate after document readiness |
| Audit by Notified Body | 3 - 4 weeks |
| Query Resolution | 2 - 3 weeks |
| License Grant (MD5) | Total approx. 3 - 4 months |
Government Fees and Costs
- MD5 License Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Additional costs may include:
- Testing fees at approved labs
- Notified body audit charges
- Consultancy charges (if applicable)
Common Challenges and Solutions
Challenge: Delays in testing due to lab backlogs
Solution: Schedule testing early and choose labs with shorter lead times from the CDSCO-approved list.
Challenge: Incomplete or inconsistent documentation
Solution: Utilize comprehensive checklists for Device Master File and Plant Master File preparation. Refer to our Device Master File Guide and Plant Master File Guide for best practices.
Challenge: Audit non-conformities
Solution: Conduct internal pre-audits and gap assessments before notified body inspections. Engage experienced consultants to ensure readiness.
Expert Consultation and Support
Our firm has a proven track record of successfully securing MD5 and MD15 licenses for dental devices. We provide tailored support including:
- Preparation and review of technical files and regulatory documentation
- Coordination with CDSCO authorities and notified bodies
- Pre-audit readiness and training
- Post-approval compliance support
Getting Started with Your CDSCO License Application
Assess your product classification to confirm the Class B status for your temporary dental crown/bridge.
Enroll on the CDSCO MD Online Portal to initiate your application process.
Apply for the test license (Form MD13) to begin manufacturing and testing prototypes.
Engage with an approved testing laboratory to obtain required product test reports.
Prepare your Device Master File, Plant Master File, Risk Management File, and QMS documents meticulously.
Submit the manufacturing license application (Form MD3) through the portal.
Coordinate with the notified body for facility audit and respond promptly to any queries.
By following these precise steps and leveraging expert support, manufacturers and importers of temporary dental crowns and bridges can efficiently secure CDSCO licensing, ensuring compliance and timely market access in India.
