CDSCO License for Dental impression material kit, 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
A collection of non-sterile devices designed to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s); This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Dental Impression Material Kit (Single-Use, Class A)
Navigating the Indian regulatory landscape for medical devices requires precision, expertise, and a clear understanding of CDSCO requirements. With over 25 years of experience and support provided to 500+ companies, we bring you an expert-level walkthrough specifically tailored for Dental Impression Material Kits (single-use, Class A) — a crucial device in dental care designed to capture accurate negative imprints of teeth.
Introduction: Overview and Regulatory Importance of Dental Impression Material Kits
Dental impression material kits are classified under Class A medical devices, indicating a low-risk profile. These kits typically include non-sterile dental impression materials and trays intended for single-use. Despite their low-risk classification, compliance with CDSCO is mandatory to ensure patient safety and regulatory adherence. The notification governing this device is 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022, reflecting the latest regulatory framework.
CDSCO Regulatory Framework for Dental Impression Material Kits
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. For Class A devices like the dental impression kit, the State Licensing Authority is responsible for granting the manufacturing license under the MD5 license scheme.
CDSCO mandates a stepwise process involving test licenses, product testing, audits by notified bodies, and submission of comprehensive documentation to ensure compliance with quality and safety standards.
Risk Classification and License Requirements for Class A Devices
Class A devices are considered low risk and are subject to the MD5 license process. This entails:
- Application on Form MD3 for the manufacturing license
- Initial test license on Form MD13
- Product testing at government-approved laboratories
- Audit by a notified body from the official list
The entire process typically spans 3 to 4 months, including testing and audit phases.
Step-by-Step Manufacturing License Process (MD5) for Dental Impression Material Kits
- Obtain Test License (Form MD13): Submit application for a test license, which generally takes 1.5 to 2 months to process.
- Product Testing: Conduct mandatory testing at CDSCO-recognized testing laboratories. Testing ensures materials meet Indian standards for biocompatibility and safety.
- Document Preparation: Compile all required technical and quality documents.
- Submit Application for Manufacturing License (Form MD3): Upload documents via the CDSCO MD Online Portal.
- Audit by Notified Body: The notified body audits your manufacturing site and quality systems.
- Respond to Queries: Address any observations raised by CDSCO or the notified body.
- Grant of MD5 License: Upon satisfactory compliance, the license is issued on Form MD5.
Manufacturing License Documents Required for Dental Impression Material Kits
To expedite approval, ensure you have the following detailed documents:
- Company Constitution: Certificate of incorporation, partnership deed, or equivalent
- Proof of Ownership/Lease of Manufacturing Premises: Valid rental agreement or ownership documents
- Technical Staff Details: Qualifications and experience of personnel involved
- No Objection Certificates (NOC): Fire safety and pollution control clearances
- Device Master File (DMF): Detailed specifications, formulation, and manufacturing process (Device Master File guide)
- Plant Master File (PMF): Facility layout, equipment details, and quality control processes (Plant Master File guide)
- Essential Principles Checklist: Compliance with Indian and international standards
- Risk Management File: Risk analysis and mitigation strategies (Risk Management guidance)
- Test Reports: From CDSCO-approved labs confirming safety and efficacy
- Labels and Instructions for Use (IFU): Clear, compliant labeling and user instructions
- Quality Management System Documents: ISO 13485 certification and SOPs
Import License Process (MD15) for Dental Impression Material Kits
Although your focus may be on manufacturing, if importing dental impression kits, an MD15 Import License from CDSCO central authority is necessary. The process involves:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO certifications, CE marking
- Submission of application on Form MD14 through the CDSCO MD Online Portal
- Queries resolution and approvals
The import license process generally takes 5 to 6 months.
Import License Documents Required
Key documents include:
- Manufacturing License of the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
Timeline and Processing Duration
| Process Step | Estimated Timeframe |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Preparation of Documents | 2 to 3 weeks |
| Submission & Audit | 1 to 1.5 months |
| Query Resolution | 2 to 4 weeks |
| Total | 3 to 4 months |
Government Fees and Costs Breakdown
- Application Fee: Rs. 5,000 per application
- Per Product Fee: Rs. 500 per product
Additional costs to consider:
- Testing fees charged by government-approved labs
- Audit fees payable to notified bodies
- Consultancy or document preparation fees if outsourced
Common Challenges and Solutions in CDSCO Licensing for Dental Impression Kits
- Incomplete Documentation: Many applicants face delays due to missing or inconsistent files. Solution: Follow the detailed checklists and utilize sample templates.
- Delayed Testing: Government labs can have backlog. Mitigate by booking testing slots early.
- Audit Non-Compliance: Ensure your manufacturing site and QMS strictly align with CDSCO and ISO requirements before audit.
- Query Handling: Prompt, clear responses to CDSCO queries shorten approval time.
Expert Consultation and Support
With our extensive experience guiding over 500 companies through CDSCO licensing, we provide:
- End-to-end regulatory consulting
- Document preparation and review
- Liaison with CDSCO and notified bodies
- Training on compliance and quality systems
Our expertise is especially valuable for manufacturers of Class A dental devices navigating the MD5 license process.
Getting Started with Your CDSCO License Application for Dental Impression Material Kits
- Register on the CDSCO MD Online Portal to create your company profile.
- Initiate the Test License (MD13) Application: Begin compiling your technical documents and apply for the test license immediately.
- Engage a Notified Body: Select from the official notified bodies list early to schedule your audit.
- Plan Product Testing: Coordinate with government-approved labs for timely testing.
- Prepare Complete Documentation: Use our detailed guides on Device Master File and Plant Master File preparation.
- Submit the MD5 Manufacturing License Application: Once testing and audit are complete.
Starting early and maintaining proactive communication with CDSCO authorities dramatically enhances the chances of a smooth and timely license grant.
For tailored, step-by-step assistance to successfully secure your CDSCO MD5 license for your Dental Impression Material Kit, reach out to our expert regulatory team today. Let us help you bring your quality dental devices to the Indian market with confidence and compliance.
