CDSCO License for Zinc polycarboxylate dental cement
Medical Device Information
Intended Use
A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid).
Comprehensive Guide to CDSCO Licensing for Zinc Polycarboxylate Dental Cement (Class B)
As specialists with over 25 years of experience in medical device regulatory compliance, we understand the critical importance of securing the correct CDSCO license for your dental device—especially for Zinc Polycarboxylate Dental Cement, a widely used Class B dental material in India. This non-sterile cement, primarily used by dental professionals as a luting agent, liner, or base, demands strict adherence to CDSCO regulations to ensure safety, efficacy, and market access.
Understanding the CDSCO Regulatory Framework for Dental Devices
The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India, categorizing devices based on risk to streamline compliance. Dental materials like Zinc Polycarboxylate Dental Cement fall under Class B (Low Moderate Risk) as per the notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.
Class B devices require a Manufacturing License (MD5 License) issued by the State Licensing Authority, which involves a detailed process including test licensing, product testing, audit by notified bodies, and documentation review.
Risk Classification and License Requirements for Zinc Polycarboxylate Dental Cement
| Parameter | Details |
|---|---|
| Device Name | Zinc Polycarboxylate Dental Cement |
| Intended Use | Dental cement for professional use (non-sterile) |
| CDSCO Risk Class | Class B (Low Moderate Risk) |
| Applicable License Type | MD5 License (Form MD3) |
| Licensing Authority | State Licensing Authority |
| Notification Reference | 29/Misc./03/2020-DC (140) Part-5 |
| Notification Date | 10.10.2022 |
Step-by-Step Manufacturing License Process (MD5) for Class B Devices
Apply for Test License (Form MD13) – Before the full manufacturing license application, obtain a test license allowing product testing from CDSCO. This process usually takes 1.5 to 2 months.
Product Testing at CDSCO-Approved Labs – Submit samples of Zinc Polycarboxylate Dental Cement to notified testing laboratories. For a comprehensive list, refer to the CDSCO Testing Laboratories.
Compile Documentation – Prepare all required technical, quality, and compliance documents.
Submit Manufacturing License Application (Form MD3) – File your application through the CDSCO MD Online Portal.
Audit by Notified Body – Engage with a notified body authorized to conduct audits for Class A and B devices. You can review the list of notified bodies here.
Address Queries and Deficiencies – Promptly respond to all CDSCO and notified body queries to avoid delays.
Grant of MD5 License (Form MD5) – Upon successful audit and document verification, the State Licensing Authority issues the license.
Total estimated duration: Approximately 3 to 4 months from test license application to license grant.
Essential Documents Required for MD5 License Application
For Zinc Polycarboxylate Dental Cement, the following documents must be meticulously prepared and submitted:
- Company Constitution Documents (e.g., Incorporation Certificate, Partnership Deed)
- Proof of Ownership or Tenancy of Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire Safety NOC from local fire department
- Pollution Control Board NOC (if applicable)
- Device Master File (DMF) detailing formulation, manufacturing process, and specifications (Learn more about DMFs here)
- Plant Master File (PMF) describing manufacturing facilities and quality systems (Guide on PMF creation)
- Essential Principles Checklist verifying compliance with Indian medical device standards
- Risk Management File demonstrating risk analysis and mitigation (Risk Management insights)
- Test Reports from CDSCO-approved laboratories confirming product safety and performance
- Labeling Samples and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certification, SOPs)
Import License Process for Dental Devices (MD15 License) – An Overview
While your device is Class B and manufacturing requires an MD5 license, importers should note that the MD15 Import License is granted by the Central Licensing Authority and takes about 5 to 6 months. This license requires additional documents like Free Sale Certificate, CE Certificate, and Wholesale License.
For more details on import licensing, refer to our comprehensive Import License Guide.
Timeline and Processing Duration Breakdown
| Process Stage | Duration (Approximate) |
|---|---|
| Test License (MD13) Application | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks (varies by lab) |
| Audit and Documentation Review | 1 – 1.5 months |
| Query Resolution | 2 – 4 weeks (dependent on response speed) |
| Total Time | 3 – 4 months |
Government Fees and Associated Costs
- Test License (MD13): No separate fee but included in overall process
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product (for every variant or SKU of Zinc Polycarboxylate Dental Cement)
- Audit & Testing Costs: Vary depending on notified body and testing laboratory fees (typically ₹50,000–₹1,00,000)
Tip: Budget for additional consultancy or document preparation fees if you engage regulatory experts.
Common Challenges and Practical Solutions
- Delayed Test Reports: Coordinate early with CDSCO-approved labs to avoid backlog delays.
- Incomplete Documentation: Use detailed checklists and cross-verify documents against CDSCO requirements.
- Audit Non-Compliance: Conduct a pre-audit internal review using notified body standards.
- Query Backlog: Assign dedicated personnel to address CDSCO queries promptly.
Expert Consultation and Support
Having helped over 500 companies navigate CDSCO licensing, we emphasize proactive planning and compliance. Our team assists in:
- Preparing robust Device and Plant Master Files
- Scheduling timely audits with notified bodies
- Liaising with CDSCO authorities to expedite approvals
- Ensuring seamless documentation and test report management
Getting Started with Your CDSCO License Application for Zinc Polycarboxylate Dental Cement
- Assess Your Device Classification: Confirm Class B status and applicability of MD5 license.
- Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to kick off the process.
- Engage Accredited Labs: Arrange product sample testing early to avoid bottlenecks.
- Prepare Complete Documentation: Use our guides on Device Master Files and Plant Master Files as templates.
- Schedule Audit with Notified Body: Select from the list of notified bodies authorized for Class B audits.
- Submit Form MD3 Application: After test license and product testing, apply for the manufacturing license.
- Manage Queries & Finalize License: Respond swiftly to CDSCO communications to secure your MD5 license.
By following these detailed steps and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing landscape for Zinc Polycarboxylate Dental Cement and successfully enter the Indian dental device market.
