CDSCO License for Dental impression material kit, 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
Devices and materials used to take the impression.
Comprehensive Guide to CDSCO Licensing for Dental Impression Material Kit (Reusable) – Class A Device
At our firm, with over 25 years of expertise in medical device regulatory consulting and having successfully guided 500+ companies, we understand the nuances of securing CDSCO licenses for specialized devices like the reusable dental impression material kit. This device falls under Class A, the lowest risk category, but navigating the regulatory process requires attention to detail to ensure compliance and timely market entry.
Understanding the Dental Impression Material Kit (Reusable) and Its Regulatory Significance
Dental impression material kits, particularly reusable types, are crucial in prosthodontics and restorative dentistry for creating accurate dental molds. Classified under the dental device category, these kits are notified under 29/Misc./03/2020-DC (140) Part-5, with the notification dated 10.10.2022, reflecting their recent inclusion in the CDSCO regulatory framework.
The importance of CDSCO licensing lies in safeguarding public health, ensuring that devices meet quality, safety, and efficacy standards before reaching Indian consumers. For manufacturers and importers, a valid license is mandatory to legally market and distribute these devices within India.
CDSCO Regulatory Framework for Dental Impression Material Kits (Reusable)
As per the Medical Device Rules (MDR) 2017, amended periodically, dental impression material kits are regulated by the Central Drugs Standard Control Organization (CDSCO). The regulatory pathway depends primarily on the device's risk classification—in this case, Class A.
The CDSCO framework mandates manufacturers to obtain a Manufacturing License (MD5) from the State Licensing Authority, while importers require an Import License (MD15) from the Central Licensing Authority. The process is designed to ensure compliance with Indian standards, including technical documentation, quality management systems, and post-market surveillance.
Risk Classification and License Requirements for Dental Impression Material Kits
- Risk Class: A (Low risk)
- License Type for Manufacturing: MD5 License (Application Form MD3)
- Issuing Authority: State Licensing Authority
- Approximate Total Timeline: 3 to 4 months (including test license and audit)
- Government Fees: Rs. 5,000 per application + Rs. 500 per product
This classification means the device is subject to a streamlined but meticulous licensing process with mandatory testing and audits to confirm compliance.
Manufacturing License Process (MD5) for Class A Dental Devices
For manufacturers aiming to produce the reusable dental impression material kit in India, the steps are as follows:
Test License Application (Form MD13): Before manufacturing license application, obtain a test license allowing production for testing purposes. This stage typically takes 1.5 to 2 months.
Product Testing: Get the device tested at a CDSCO-approved government testing laboratory to verify compliance with safety and quality standards. Refer to the list of testing laboratories.
Preparation of Technical and Quality Documents: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Submission of Manufacturing License Application (Form MD3): Apply through the CDSCO MD Online Portal.
Audit by Notified Body: An audit by an accredited notified body is mandatory for Class A devices. You can check the list of notified bodies authorized to conduct these audits.
Resolution of Queries: Respond promptly to any queries or clarifications from the licensing authority or notified body.
Grant of Manufacturing License (Form MD5): Upon satisfactory completion of all steps, the State Authority issues the MD5 license.
Manufacturing License Documents Required for the Dental Impression Material Kit
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Our detailed Device Master File guide can help you prepare this critical document.
- Plant Master File (PMF): See our Plant Master File Guide for step-by-step instructions.
- Essential Principles Checklist
- Risk Management File: Incorporate standards from ISO 14971; our Risk Management guide provides practical insights.
- Test Reports from Government-Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification evidence
Import License Process (MD15) for Dental Impression Material Kits
If you are an importer looking to market reusable dental impression material kits in India, the process is slightly different:
- No Test License Required
- Apply on Form MD14 via the CDSCO MD Online Portal
- Submit Documents Including:
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
- Government Fees: For Class A devices, approximately 50 per product
- Timeline: Approximately 5 to 6 months due to detailed scrutiny
For more specifics on import license procedures, our Import License Guide is a valuable resource.
Timeline and Processing Duration for MD5 License
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 4 weeks |
| Application Submission & Audit | 4 - 6 weeks |
| Query Resolution | 2 - 3 weeks |
| Total Estimated Time | 3 - 4 months |
Keep in mind that adherence to documentation quality and timely responses to queries can significantly streamline this timeline.
Government Fees and Cost Breakdown
- Application Fee: Rs. 5,000 per manufacturing license application
- Product Fee: Rs. 500 per product
- Test License Fee: Nominal and included in application fees
- Audit Charges: Fees payable directly to the notified body, generally ranging from Rs. 50,000 to Rs. 1,00,000 depending on scope
Transparent budgeting is essential; consider audit and testing fees as part of your regulatory compliance costs.
Common Challenges and Practical Solutions
1. Delays in Testing and Audit Scheduling
- Solution: Pre-book testing slots at CDSCO-approved labs and coordinate early with notified bodies for audit schedules.
2. Incomplete Documentation Leading to Queries
- Solution: Utilize checklists from our comprehensive guides and conduct internal audits before submission.
3. Understanding Regulatory Updates
- Solution: Regularly monitor CDSCO notifications and subscribe to official updates to stay compliant with amendments like Notification 29/Misc./03/2020-DC (140) Part-5.
4. Technical Staff Qualifications
- Solution: Employ qualified personnel with relevant experience or engage consultants during the application phase.
Expert Consultation and Support
Navigating the CDSCO licensing process for dental impression material kits can be complex, especially for first-time applicants. Our seasoned regulatory consultants offer:
- End-to-end application management
- Customized document preparation
- Liaison with notified bodies and testing labs
- Post-approval compliance support
Our track record of 500+ successful licenses in similar Class A devices ensures that your application is in expert hands.
Getting Started with Your CDSCO License Application for Dental Impression Material Kits
Assess Your Device Classification: Confirm that the reusable dental impression material kit falls under Class A as per Medical Device Classification.
Register on CDSCO MD Online Portal: Create your account to access application forms and track your submissions.
Initiate Test License Application (MD13): Begin producing sample devices for testing.
Engage Accredited Testing Laboratory: Coordinate testing early to avoid bottlenecks.
Prepare Comprehensive Documentation: Refer to our Device Master File and Plant Master File guides to compile a robust technical dossier.
Schedule Audit with Notified Body: Early engagement facilitates smoother inspections.
Submit Manufacturing License Application (MD3): Complete all steps online and prepare for prompt query responses.
Plan Budget and Timeline: Allocate resources and anticipate a 3 to 4 month process for license grant.
By following this structured approach and leveraging expert support, manufacturers can efficiently obtain their CDSCO MD5 manufacturing license, enabling successful market access for reusable dental impression material kits in India.
For personalized assistance or to initiate your application process, contact our regulatory consultancy team today.
