CDSCO License for Dental spatula, 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 dental instrument used to mix dental materials. Some are equipped with an injection function.
Comprehensive Guide to CDSCO License for Reusable Dental Spatula (Class A Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and a track record of assisting 500+ medical device companies, we understand the nuances of securing CDSCO licenses in India. Today, we focus on a specific device: the reusable dental spatula, a Class A medical device used widely in dental practices for mixing dental materials, including models with injection functions.
Understanding the Device and Its Regulatory Importance
The reusable dental spatula falls under the dental device category and is classified as Class A—the lowest risk class as per the latest CDSCO notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. Despite its lower risk classification, regulatory compliance is mandatory to ensure patient safety and market access in India. Proper licensing not only demonstrates adherence to quality standards but also builds trust with dental practitioners and importers.
CDSCO Regulatory Framework for Reusable Dental Spatulas
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, governs the licensing and regulation of medical devices in India. For Class A devices like the dental spatula, the State Licensing Authority issues the manufacturing license under the MD5 category, based on Application Form MD3.
The process involves multiple steps including obtaining a test license (Form MD13), product testing at government-approved labs, document submission, audit by notified bodies, and final license grant.
Risk Classification and License Requirements
- Device Name: Dental Spatula, Reusable
- Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Issuing Authority: State Licensing Authority
- Notification Reference: 29/Misc./03/2020-DC (140) Part-5
Understanding that this device is Class A means the license application route is streamlined compared to higher-risk devices, but still requires thorough compliance.
Manufacturing License Process (MD5) for Dental Spatulas
- Test License (Form MD13): Initiate the process by applying for a test license, valid for 6 months, allowing you to manufacture the device for testing purposes.
- Product Testing: Get the dental spatula tested at CDSCO-approved laboratories to establish compliance with Indian standards. Find testing labs here.
- Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and relevant QMS documents.
- License Application: Submit your manufacturing license application on Form MD3 via the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body will conduct a thorough audit of your manufacturing facility and quality systems. Check the list of notified bodies for eligible auditors.
- Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
- License Grant: After successful audit and clearance, the MD5 manufacturing license is issued.
Manufacturing License Documents Required
For reusable dental spatulas, the documentation must be precise and complete to avoid delays:
- Company Constitution (MoA, AoA)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire and Pollution NOCs
- Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
- Plant Master File describing manufacturing site and equipment (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with Indian regulatory standards
- Risk Management File addressing potential hazards and mitigations (Risk Management)
- Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, ideally ISO 13485 certified
Import License Process (MD15) for Reusable Dental Spatulas
If you are an importer, the import license under Form MD14 (MD15 license) is required from the Central Licensing Authority. While the manufacturing license is state-level, import licenses are centrally administered.
Key points:
- No test license required.
- Submit documents like Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate if applicable, Device and Plant Master Files, and Wholesale License.
- Apply via the CDSCO MD Online Portal.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution documents
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 4 weeks |
| Document Preparation | 2 to 4 weeks |
| Application Processing (MD5) | 1 to 2 months |
| Audit and Query Resolution | 2 to 4 weeks |
| Total Estimated Time | 3 to 4 months |
Government Fees and Costs
- Test License (MD13): Rs. 5000
- MD5 Manufacturing License Application Fee: Rs. 5000 per application
- Product-wise Fee: Rs. 500 per dental spatula model
- Audit Fees: Variable based on notified body
Note: Costs for product testing and document preparation services vary depending on lab and consultant fees.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with government-approved testing labs and pre-validate your product specifications to avoid rejections.
Challenge 2: Incomplete Documentation
- Solution: Use checklists and expert templates for Device and Plant Master Files. Our Device Master File guide can streamline this process.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal mock audits to ensure your quality system meets CDSCO standards before the notified body visit.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory liaison to monitor and respond to queries promptly.
Expert Consultation and Support
With our extensive experience helping over 500 companies obtain CDSCO licenses, we offer tailored consulting services including:
- Gap analysis and readiness assessment
- Complete documentation preparation and review
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Training on post-approval compliance
Our expert guidance reduces processing times and improves approval success rates.
Getting Started with Your CDSCO License Application for Dental Spatulas
- Assess Your Product: Confirm the classification and intended use of your dental spatula.
- Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
- Prepare Documentation: Gather and prepare all required documents using our expert guides.
- Apply for Test License (MD13): Submit your test license application to commence product manufacturing for testing.
- Schedule Product Testing: Coordinate with government-approved labs.
- Submit Manufacturing License Application (MD5): Once test results are satisfactory, apply for the manufacturing license.
- Prepare for Audit: Conduct internal audits and prepare your staff for the notified body inspection.
- Respond to Queries: Be proactive in addressing any clarifications from authorities.
Taking these steps with professional support will pave the way for a successful CDSCO license grant, enabling you to manufacture and market your reusable dental spatula in India confidently.
For further assistance, our consultancy team is ready to help you navigate every stage of the CDSCO licensing journey. Connect with us today and secure your medical device license with ease.
