CDSCO License for Dental excavator, 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 is a single use device intended to cutting, clean out and shape a carious cavity before filling it.
Comprehensive Guide to CDSCO Licensing for Single-Use Dental Excavators (Class A Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for manufacturers and importers aiming to launch single-use dental devices like the dental excavator. With over 25 years of expertise and having supported 500+ companies, we provide you actionable insights and precise guidance on obtaining the CDSCO license efficiently for your Class A dental excavator.
Understanding the Dental Excavator and Its Regulatory Importance
The dental excavator is a single-use instrument designed specifically for cutting, cleaning, and shaping carious cavities before filling. As per the CDSCO notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, this device is classified as Class A (low risk). Despite its low risk, regulatory compliance is essential to ensure safety, efficacy, and legal market access in India.
CDSCO Regulatory Framework for Single-Use Dental Excavators
Medical devices in India fall under the purview of the Central Drugs Standard Control Organization (CDSCO). Class A devices such as the dental excavator require a manufacturing license under the MD5 category, which is granted by the State Licensing Authority. The regulatory framework mandates conformity to quality standards, product testing, and thorough documentation.
Risk Classification and License Requirements for Dental Excavators
- Risk Class: Class A (Low risk)
- License Type: MD5 Manufacturing License (Form MD3 application)
- Authority: State Licensing Authority
- Applicable Regulations: As per CDSCO notification dated 10.10.2022
For Class A devices, the license process is comparatively streamlined but still requires strict adherence to testing and documentation.
Manufacturing License Process (MD5) for Single-Use Dental Excavator
- Test License (Form MD13): Before applying for the MD5 license, you must obtain a test license to manufacture samples for testing. This takes approximately 1.5 to 2 months.
- Product Testing: Samples must be tested at CDSCO-recognized laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories.
- Document Preparation: Prepare technical documentation including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
- Application Submission (Form MD3): Submit the complete application via the CDSCO MD Online Portal.
- Audit by Notified Body: A mandatory audit by a CDSCO-notified body ensures your manufacturing facility meets GMP and quality standards. Check the list of notified bodies.
- Queries and Clarifications: Address any queries raised by the licensing authority or notified body promptly.
- Grant of License (Form MD5): Upon successful completion, the manufacturing license is issued.
Manufacturing License Documents Required for Dental Excavators
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualification Proof of Technical Staff
- Fire and Pollution NOCs
- Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
- Plant Master File outlining manufacturing site and processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance to Indian standards
- Risk Management File (Risk Management)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485 certification is highly recommended)
Import License Process (MD15) for Dental Excavators
For importers wishing to bring single-use dental excavators into India, an MD15 import license is mandatory. This license is issued by the Central Licensing Authority and takes approximately 5-6 months.
Key Steps:
- Prepare required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master and Plant Master Files.
- Submit application via the CDSCO MD Online Portal.
- Respond promptly to any department queries.
For detailed guidance on import licenses, visit our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from exporting country
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and address proof
Timeline and Processing Duration for MD5 License
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Application Preparation | 2 - 3 weeks |
| Audit by Notified Body | 3 - 4 weeks |
| Queries and Final Grant | 3 - 4 weeks |
Total Time to Obtain MD5 License: Approximately 3 to 4 months
Government Fees and Costs for MD5 License
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product (for the dental excavator single-use device)
Additional costs include fees for product testing, notified body audit charges, and consultancy if opted.
Common Challenges and Solutions
- Delayed Test Reports: Choose CDSCO-approved laboratories with good turnaround times. Early sample submission helps avoid bottlenecks.
- Incomplete Documentation: Use comprehensive checklists during document preparation. Refer to our Device and Plant Master File guides.
- Audit Non-Compliance: Conduct internal pre-audits and staff training to ensure GMP compliance. Familiarize your team with notified body requirements.
- Query Resolution Delays: Assign a dedicated regulatory liaison to monitor communication and respond swiftly.
Expert Consultation and Support
With decades of experience and over 500 successful CDSCO licensing projects, our consultancy offers end-to-end assistance including:
- Gap analysis of current documentation
- Preparation of Device and Plant Master Files
- Coordination with testing laboratories and notified bodies
- Application submission and follow-up
- Training for compliance and audit readiness
Engage with our experts early to streamline your licensing journey.
Getting Started with Your CDSCO License Application for Dental Excavators
- Assess Device Classification: Confirm your dental excavator is Class A per the latest CDSCO notifications.
- Initiate Test License Application (MD13): Prepare samples and apply via the CDSCO MD Online Portal.
- Select Testing Laboratory: Choose an approved lab from the official list to conduct product testing.
- Prepare Documentation: Develop thorough Device and Plant Master Files, QMS documentation, and risk management files.
- Schedule Audit with Notified Body: Coordinate with a notified body for your facility audit (Notified Bodies List).
- Submit MD5 Application (Form MD3): Upload all documents and evidence on the CDSCO portal.
- Respond Rapidly to Queries: Maintain communication with CDSCO and notified bodies to resolve any outstanding issues.
By following these practical steps, manufacturers and importers can achieve CDSCO compliance confidently and bring their single-use dental excavators to the Indian market with ease.
For tailored assistance or to discuss your specific project, reach out to our regulatory consultants who specialize in medical device licensing in India.
