CDSCO License for Periodontal root surface regeneration material
Medical Device Information
Intended Use
A bio absorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support.
Comprehensive Guide to CDSCO Licensing for Periodontal Root Surface Regeneration Material (Class C)
As specialists with over 25 years of experience in medical device regulatory affairs, we have supported more than 500 companies in securing CDSCO licenses across India. In this detailed guide, we focus on the regulatory pathway for Periodontal Root Surface Regeneration Material — a Class C dental device designed to restore tooth support lost due to periodontal disease or trauma.
Understanding Your Medical Device: Periodontal Root Surface Regeneration Material
This bio-absorbable material is intended for periodontal flap surgery to create a matrix on the root surface that promotes selective cell migration and attachment, facilitating regeneration of lost periodontal support. Recognized under notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, it falls within the dental device category and is classified as Risk Class C by CDSCO.
CDSCO Regulatory Framework for Class C Dental Devices
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. For Class C devices such as periodontal regeneration materials, the regulatory process is centralized and requires obtaining the MD9 Manufacturing License granted by the Central Licensing Authority.
This tiered regulatory approach ensures patient safety by imposing stringent testing, documentation, and audit requirements for higher-risk devices.
Risk Classification and License Requirements for Periodontal Regeneration Materials
As a Class C device, your product involves moderate to high risk, necessitating:
- An MD13 Test License for initial product testing
- Testing from CDSCO-recognized laboratories
- Submission of a comprehensive application on the CDSCO MD Online Portal
- Audit and inspection by CDSCO officials
The license application uses Form MD7 for manufacturing and results in an MD9 license upon approval.
Manufacturing License Process (MD9) for Class C Devices
The MD9 license process typically spans 4 to 5 months from start to finish and involves the following steps:
Apply for Test License (Form MD13): This initial license allows you to conduct testing of your device samples at government-approved laboratories. Processing takes approximately 1.5 to 2 months.
Product Testing: Testing must be performed at CDSCO-recognized labs. You can refer to the list of approved Testing Laboratories to select a facility.
Documentation Preparation: Prepare the required technical and quality documents, including your Device Master File and Plant Master File.
Submit MD9 Application (Form MD7): After compiling all documents and test results, submit your application through the CDSCO MD Online Portal.
Audit and Inspection: CDSCO inspectors will audit your manufacturing site and review documents to ensure compliance.
Respond to Queries: Address any queries or observations raised by the department or auditors promptly.
Grant of MD9 License: Upon satisfactory review, CDSCO issues the manufacturing license in Form MD9.
Manufacturing License Documents Required for Periodontal Regeneration Materials
For Class C devices, ensure you prepare the following comprehensive documentation:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Personnel
- Fire Safety Certificate (Fire NOC)
- Pollution Control Board Clearance (Pollution NOC)
- Device Master File (DMF): Detailed product design, materials used, manufacturing process, and validation. Our in-depth Device Master File guide provides practical insights.
- Plant Master File (PMF): Comprehensive overview of your manufacturing facility, equipment, and quality systems. Refer to our Plant Master File guide for templates and tips.
- Essential Principles Checklist (compliance with Indian and international standards)
- Risk Management File demonstrating hazard identification and mitigation strategies (see our Risk Management resource)
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485:2016 certification)
Import License Process (MD15) for Periodontal Regeneration Material
If you are an importer rather than a manufacturer, the process involves applying for the MD15 Import License through the Central Licensing Authority. This process generally takes 5 to 6 months and does not require a test license.
Required documents include:
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 and CE Certificates
- Device and Plant Master Files
- Wholesale License
- Company Constitution
Submit your application for import license on the CDSCO MD Online Portal.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Documentation Preparation | 2 – 3 weeks |
| MD9 License Application | Submitted online |
| Audit & Inspection | 2 – 4 weeks |
| Query Resolution | 2 – 4 weeks |
| Total Approximate Time | 4 – 5 months |
Government Fees and Costs
For Class C devices such as periodontal root surface regeneration materials, the fee structure is as follows:
- Application Fee: Rs 50,000 per application
- Product Fee: Rs 1,000 per product
These fees are payable online at the time of application submission via the CDSCO MD Online Portal.
Common Challenges and Practical Solutions
- Delayed Testing Approvals: Test license processing and scheduling with government labs can delay timelines. We recommend early engagement with labs and submitting complete documentation.
- Audit Non-Compliance: Common audit issues include incomplete QMS documentation or inadequate facility maintenance. Conduct internal pre-audits to identify gaps.
- Query Backlogs: Proactively prepare thorough responses with supporting documents. Our experts can assist in drafting precise replies to expedite clearance.
- Document Gaps: Missing or incomplete Device Master Files and Risk Management documentation are frequent hurdles. Utilize expert templates and guidance to ensure completeness.
Expert Consultation and Support
Navigating the CDSCO licensing process for Class C devices can be complex. Our experienced regulatory consultants have successfully guided over 500 manufacturers and importers through these exact steps. We provide:
- Comprehensive document preparation assistance
- Coordination with notified bodies and testing labs
- Pre-audit readiness evaluations
- Personalized timelines and project management
Getting Started with Your CDSCO License Application
To initiate your licensing process for periodontal root surface regeneration material:
- Register on the CDSCO MD Online Portal: Create your account to access application forms and status tracking.
- Prepare and Submit Test License Application (MD13): Begin with securing your test license, allowing product testing at authorized labs.
- Select Accredited Testing Laboratories: Choose from the CDSCO list of testing laboratories for product testing.
- Collect and Organize Required Documents: Utilize our guides to develop your Device and Plant Master Files, Risk Management File, and other essential documents.
- Plan for Audit: Review your facility and QMS to ensure compliance before CDSCO inspection.
- Submit MD9 Application (Form MD7): After successful testing, apply for your manufacturing license.
Our team stands ready to support you through every step—contact us to schedule a consultation and gain tailored insights to accelerate your CDSCO licensing journey.
Embarking on CDSCO licensing for your periodontal regeneration product is a strategic move to access India's thriving dental device market. With the right preparation and expert guidance, you can achieve compliance efficiently and confidently.
