CDSCO License for Dental soft-tissue matrix implant, animal-derived
Medical Device Information
Intended Use
A sterile, bio absorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Dental Soft-Tissue Matrix Implant (Animal-Derived)
As a trusted regulatory consultancy with over 25 years of experience and having assisted 500+ companies in navigating the complex CDSCO licensing landscape, we understand the unique challenges manufacturers and importers face with advanced medical devices. This guide focuses on the Dental Soft-Tissue Matrix Implant, animal-derived, a Class C medical device regulated under the Indian medical device framework with notification reference 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022.
Introduction: Device Overview and Regulatory Importance
The dental soft-tissue matrix implant is a sterile, bio-absorbable collagen matrix derived from animal sources (such as porcine collagen). It is designed to support oral soft tissue regeneration in periodontal procedures. Given its critical role in tissue regeneration and its bio-absorbable nature, it is classified as a Class C device, requiring stringent regulatory compliance to ensure patient safety and efficacy.
Manufacturers and importers must secure the appropriate CDSCO license to legally market this device in India. Proper adherence to regulatory standards not only facilitates market access but also demonstrates commitment to quality and safety, bolstering trust among dental professionals and end-users.
CDSCO Regulatory Framework for Dental Soft-Tissue Matrix Implants
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017. For devices like dental soft-tissue matrix implants, which fall under Class C, the licensing authority is the Central Licensing Authority (CLA).
Key regulatory requirements include:
- Obtaining a Manufacturing License (MD9) or Import License (MD15) depending on the business model.
- Compliance with quality management systems aligned with ISO 13485:2016.
- Product testing at CDSCO-approved laboratories.
- Submission of detailed technical documentation including Device Master File and Plant Master File.
For more on medical device classifications, refer to our Medical Device Classification guide.
Risk Classification and License Requirements
Your dental soft-tissue matrix implant, being a Class C device, falls under a higher risk category due to its invasive nature and biological origin. The regulatory pathway entails:
| Device Class | License Type | Application Form | Licensing Authority | Timeline | Fees |
|---|---|---|---|---|---|
| Class C | MD9 | MD7 | Central Licensing Authority | 4-5 months | Rs 50,000 + Rs 1,000 per product |
This includes obtaining a test license (MD13) initially, product testing, followed by documentation and audits.
Manufacturing License Process (MD9) for Class C Devices
Securing an MD9 manufacturing license for your dental implant involves a multi-step process:
- Apply for Test License (MD13): Initiates the testing phase, taking approximately 1.5-2 months.
- Product Testing: Conducted at CDSCO-approved laboratories to validate safety and performance.
- Document Preparation: Compile comprehensive technical files, including Device Master File, Plant Master File, Risk Management File, and more.
- Application Submission (Form MD7): Submit through the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: On-site inspection to verify compliance.
- Resolve Queries: Address any observations or additional information requests.
- Grant of License (Form MD9): Issuance of manufacturing license upon satisfactory compliance.
For detailed steps and practical insights, see our dedicated MD9 License Guide.
Manufacturing License Documents Required
Thorough documentation is the backbone of a successful license application. For your dental soft-tissue matrix implant, the following documents must be prepared and submitted:
- Company Constitution (Incorporation certificate, partnership deed, etc.)
- Proof of Ownership or Lease of Premises
- Technical Staff Details (Qualifications, experience of key personnel)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed product specifications, manufacturing process, quality controls. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Facility layout, equipment details, and quality systems. Refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian medical device standards.
- Risk Management File: Risk analysis and mitigation strategies as per medical device risk management.
- Test Reports: From CDSCO-recognized labs. A list of Testing Laboratories is available online.
- Labels and Instructions for Use (IFU)
- Quality Management System Documentation (ISO 13485:2016 compliance)
Ensuring these documents are detailed, coherent, and compliant significantly reduces back-and-forth with CDSCO inspectors.
Import License Process (MD15) for Dental Soft-Tissue Matrix Implant
If your business model involves importing the dental implant into India, the process for obtaining an MD15 import license from the Central Licensing Authority is as follows:
- Document Preparation: Includes manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master and Plant Master Files.
- License Application (Form MD14): Submit via the CDSCO MD Online Portal.
- Query Resolution: Address any clarifications sought by CDSCO.
- License Grant (Form MD15): Upon successful verification.
Note, unlike manufacturing licenses, no test license is required for imports.
Documents Required for MD15 License
- Valid manufacturing license from country of origin
- Free Sale Certificates
- ISO 13485:2016 and CE Certificates
- Device Master File
- Plant Master File
- Wholesale license in India
- Company Constitution
For a comprehensive walkthrough, see our Import License Guide.
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD9 Manufacturing License | 4 - 5 months (including test license and audit) |
| MD15 Import License | 5 - 6 months |
From initiation to license grant, manufacturers should anticipate approximately 4-5 months for Class C devices, factoring in test licensing, laboratory testing, audits, and query resolution.
Government Fees and Costs
For your dental soft-tissue matrix implant (Class C), the fee structure is as follows:
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing License | Rs 50,000 | Rs 1,000 |
| MD15 Import License | USD 3,000/site | USD 1,500 |
Additional costs to budget for include:
- Product testing fees at government-approved labs
- Notified body audit charges
- Consultancy or documentation preparation fees (if outsourced)
Budgeting for these ensures smoother cash flow and avoids unexpected delays.
Common Challenges and Solutions
Challenge: Delays in Laboratory Testing
Solution: Select testing laboratories with proven track records and communicate timelines in advance. Utilize the CDSCO Testing Laboratories list to choose accredited facilities.
Challenge: Incomplete Documentation
Solution: Engage experienced regulatory consultants to prepare and review your Device Master File and Plant Master File. Our guides on DMF and PMF are invaluable resources.
Challenge: Audit Non-Compliance
Solution: Prepare your facility in advance following notified body checklists. Conduct internal audits to identify gaps.
Challenge: Query Resolution Delays
Solution: Respond promptly and comprehensively to CDSCO queries. Maintaining open communication with the authority expedites approval.
Expert Consultation and Support
Navigating the CDSCO regulatory framework, especially for higher-risk devices like the dental soft-tissue matrix implant, can be daunting. With our extensive experience, we offer:
- Tailored regulatory strategy planning
- Complete documentation preparation and review
- Coordination with notified bodies and testing labs
- Audit readiness support
- End-to-end application submission and follow-up
Our commitment is to reduce your time-to-market while ensuring full compliance.
Getting Started with Your CDSCO License Application
To initiate your CDSCO licensing journey for the dental soft-tissue matrix implant, follow these actionable steps:
- Classify Your Device: Confirm your device is Class C using the Medical Device Classification guide.
- Prepare Essential Documents: Begin compiling your Device Master File and Plant Master File.
- Apply for Test License (Form MD13): Submit your application via the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.
- Engage a Notified Body: Identify and engage a notified body for audit services. Use the Notified Bodies List to select an authorized auditor.
- Prepare for Audit: Conduct internal reviews and ensure all quality systems are in place.
- Submit Manufacturing License Application (Form MD7) after successful testing and audit.
Starting early and maintaining a structured timeline ensures smoother approval and faster market entry.
For professional assistance, contact our regulatory experts, and leverage our decades of expertise to secure your CDSCO license confidently.
