CDSCO License for Calcium hydroxide dental cement
Medical Device Information
Intended Use
Use as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid.
Comprehensive Guide to CDSCO Licensing for Calcium Hydroxide Dental Cement (Class B Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized products like Calcium Hydroxide Dental Cement. This dental cement, primarily used as a direct restorative material with a hardening reaction between calcium hydroxide and salicylic acid, falls under Risk Class B according to the latest CDSCO notification (29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022). As a company with over 25 years of experience helping 500+ manufacturers successfully acquire CDSCO licenses, we provide you with a detailed, step-by-step blueprint to ensure a smooth regulatory approval process.
CDSCO Regulatory Framework for Calcium Hydroxide Dental Cement
The Central Drugs Standard Control Organization (CDSCO) regulates the import, manufacture, and sale of medical devices in India. For dental devices like Calcium Hydroxide Dental Cement classified as Class B, the manufacturing license falls under the MD5 license category, which is granted by the State Licensing Authority. This framework ensures that devices meet quality, safety, and efficacy standards before reaching patients.
Risk Classification and License Requirements
Per CDSCO guidelines, medical devices are classified into Classes A, B, C, and D based on risk. Calcium Hydroxide Dental Cement is a Class B device, indicating low to moderate risk. The relevant license for manufacturing this device is:
- MD5 License (Form MD3): For manufacturing Class A and B devices, issued by the State Licensing Authority.
This classification influences the documentation, audit requirements, fees, and processing timelines.
Manufacturing License Process (MD5) for Calcium Hydroxide Dental Cement
The MD5 license process is rigorous yet well-defined. The key stages include:
Test License (Form MD13): First, you must apply for a test license allowing initial manufacturing to generate samples for testing. This typically takes 1.5 to 2 months.
Product Testing: Samples must undergo testing at government-approved laboratories to verify compliance with standards. Refer to the Testing Laboratories recognized by CDSCO.
Document Preparation: Assemble comprehensive documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, Quality Management System (QMS) documents, labels, and Instructions for Use (IFU).
License Application Submission: Submit Form MD3 via the CDSCO MD Online Portal along with the required fees and documents.
Audit by Notified Body: An audit by a CDSCO notified body ensures compliance with regulatory and manufacturing standards. Check the list of notified bodies for approved auditors.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
Grant of MD5 License (Form MD5): Once all requirements are met, the license is issued.
Manufacturing License Documents Required for MD5
For Class B dental cement, the documentation must be thorough, including:
- Company Constitution Document (e.g., MOA/ AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Comprehensive product details, formulation, specifications. Our Device Master File Guide provides practical insights.
- Plant Master File (PMF): Details on manufacturing facilities and equipment. See our Plant Master File Guide.
- Essential Principles Checklist: Compliance confirmation with Indian and international standards.
- Risk Management File: Documentation of risk analysis and mitigation strategies. Learn more about Risk Management.
- Test Reports: From CDSCO-approved labs validating product safety and efficacy.
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: Evidence of ISO 13485 certification or equivalent.
Import License Process (MD15) for Calcium Hydroxide Dental Cement
If you plan to import this dental cement, you need an MD15 License issued by the Central Licensing Authority. Key highlights:
- No test license (MD13) required.
- Submit Form MD14 via the CDSCO MD Online Portal.
- Required documents include 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 License, and Company Constitution.
Processing generally takes 5–6 months.
Import License Documents Required
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Document
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| License Application Processing | 1 – 2 months |
| Audit and Query Resolution | 3 – 4 weeks |
| Total Duration for MD5 | 3 – 4 months |
For import license (MD15), expect 5–6 months.
Government Fees and Costs
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
These fees are payable via the CDSCO portal.
Additional costs to budget for:
- Testing laboratory fees (varies by lab and test complexity)
- Notified body audit fees
- Consultant fees if applicable
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with CDSCO-approved labs and prepare samples promptly.
Challenge 2: Incomplete Documentation
- Solution: Use detailed checklists and refer to our Device Master File Guide and Plant Master File Guide to ensure completeness.
Challenge 3: Audit Non-Conformities
- Solution: Conduct internal audits and gap assessments before official audits.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel to respond quickly and comprehensively.
Expert Consultation and Support
With over 25 years of experience and a track record of supporting 500+ companies, we offer tailored consulting services that include:
- Gap assessment and readiness audits
- Document preparation and review
- Liaison with CDSCO and notified bodies
- Training your technical and regulatory teams
Our expertise can significantly reduce approval timelines and increase your chances of first-time success.
Getting Started with Your CDSCO License Application for Calcium Hydroxide Dental Cement
Register on the CDSCO MD Online Portal: This is the mandatory platform for all applications.
Initiate Test License Application (Form MD13): This enables product testing and sample manufacture.
Plan Product Testing with Approved Labs: Early engagement will help minimize waiting times.
Prepare Comprehensive Documentation: Utilize our guides and templates to develop your Device and Plant Master Files and other required documents.
Schedule and Prepare for Notified Body Audit: Choose an approved body from the Notified Bodies List and ensure your facility is audit-ready.
Submit MD5 License Application (Form MD3): After successful testing and document compilation, apply via the CDSCO portal.
Respond Promptly to Queries: Maintain clear communication with CDSCO to expedite the review.
By following these detailed steps tailored specifically for Calcium Hydroxide Dental Cement, you will position your company for regulatory success and timely market entry. For personalized assistance, feel free to reach out to our regulatory experts who are ready to guide you through every phase of your CDSCO licensing journey.
