CDSCO License for Dental bone matrix implant, animal-derived
Medical Device Information
Intended Use
A sterile bio absorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation.
Comprehensive CDSCO Licensing Guide for Dental Bone Matrix Implant (Animal-Derived) – Class C Medical Device
Dental bone matrix implants, primarily derived from animal sources such as bovine or porcine bone or dentin matrix, play a crucial role in maxillofacial and mandibular bone reconstruction. These sterile, bioabsorbable devices provide osteoconductive scaffolding to promote endogenous bone growth, making them indispensable in dental surgeries and trauma repair. Given their implantable nature and critical use, Dental Bone Matrix Implants are categorized under Class C risk devices by CDSCO, necessitating stringent regulatory compliance to ensure safety and efficacy.
With over 25 years of regulatory consultancy experience and having supported 500+ companies, we understand the complexities involved in navigating the CDSCO licensing process for such advanced medical devices. This detailed guide outlines the regulatory framework, licensing pathways, documentation, timelines, costs, and practical tips for manufacturers and importers targeting the Indian market.
CDSCO Regulatory Framework for Dental Bone Matrix Implants
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017, notified under the Drugs and Cosmetics Act. Dental bone matrix implants, being implantable and bioabsorbable, fall under Class C according to the MDR classification system, which implies a moderate to high risk requiring Central Licensing Authority approval.
Their regulatory oversight includes:
- Mandatory manufacturing and import licensing
- Compliance with Essential Principles of Safety and Performance
- Mandatory product testing from CDSCO-approved laboratories
- Submission of Device Master File (DMF) and Plant Master File (PMF)
- Risk management documentation
You can verify the classification and recent notifications such as Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022 which explicitly mentions these implants under Class C.
Risk Classification and License Requirements for Class C Devices
Class C devices, including dental bone matrix implants, require a manufacturing license in Form MD9 and import license in Form MD15, both granted by the Central Licensing Authority (CDSCO headquarters).
| License Type | Application Form | Authority | Timeline | Fees |
|---|---|---|---|---|
| Manufacturing License | MD7 (for MD9) | Central Licensing | 4-5 months | ₹50,000 + ₹1,000 per product |
| Import License | MD14 (for MD15) | Central Licensing | 5-6 months | 1,500/product |
The process involves obtaining a test license (Form MD13) before applying for manufacturing license, product testing from CDSCO-approved labs, and audit by CDSCO inspectors.
Stepwise Manufacturing License Process for Dental Bone Matrix Implant (MD9 License)
Test License (Form MD13):
- Apply for a test license to manufacture the device for testing purposes.
- Timeline: Approximately 1.5 to 2 months.
Product Testing:
- Submit device samples for testing to CDSCO-approved laboratories.
- Reference the list of testing laboratories accredited for medical device testing.
- Testing duration varies based on device complexity; typically 1-2 months.
Document Preparation:
- Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
- For detailed guidance, see our Device Master File guide and Plant Master File guide.
Application Submission (Form MD7):
- Submit a manufacturing license application for MD9 through the CDSCO MD Online Portal.
Audit by CDSCO Inspectors:
- After document review, CDSCO will schedule an on-site audit evaluating compliance with MDR, QMS, and manufacturing processes.
Query Resolution:
- Address any observations or queries raised by CDSCO inspectors or departments promptly.
Grant of Manufacturing License (Form MD9):
- Upon satisfactory compliance, CDSCO issues the MD9 license allowing commercial manufacturing.
Manufacturing License Documents Required for Dental Bone Matrix Implant
The following documents must be meticulously prepared and submitted:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- List and Qualification Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications, design, and manufacturing process
- Plant Master File (PMF) describing facility layout, equipment, and quality controls
- Essential Principles Checklist confirming compliance with safety and performance standards
- Risk Management File documenting hazard analysis and mitigation strategies (Risk Management Guide)
- Product Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU) complying with MDR requirements
- Quality Management System (QMS) certificates, preferably ISO 13485:2016
Attention to detail in these documents expedites approval and reduces audit queries.
Import License Process for Dental Bone Matrix Implant (MD15 License)
Importers of Dental Bone Matrix Implants must secure an MD15 import license from CDSCO. The process includes:
Document Preparation:
- Gather manufacturing license (MD9) from the country of origin.
- Obtain Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable).
- Prepare Device Master File and Plant Master File.
- Submit wholesale license and company incorporation documents.
Application Submission:
- Submit application Form MD14 for MD15 license via the CDSCO MD Online Portal.
Review and Queries:
- CDSCO reviews application and may raise queries.
Grant of Import License:
- After satisfactory response, CDSCO grants import license in Form MD15.
Typical processing time for import license is 5-6 months.
Timeline and Processing Duration Summary
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5–2 months |
| Product Testing | 1–2 months |
| Document Preparation | Concurrent with testing |
| Manufacturing License (MD9) | 4–5 months total (including test license and audit) |
| Import License (MD15) | 5–6 months |
Starting early with test license application and thorough documentation preparation can significantly reduce total approval time.
Government Fees and Costs for Dental Bone Matrix Implant Licensing
- MD9 Manufacturing License Application: ₹50,000 + ₹1,000 per product
- MD13 Test License: Included in overall process
- MD15 Import License: 1,500 per product
These fees are payable online at the CDSCO MD Online Portal. Budgeting accurately for these fees along with testing costs (which vary per product and lab) is critical.
Common Challenges and Practical Solutions
Challenge: Delays in audit scheduling and query resolution.
Solution: Maintain proactive communication with CDSCO officials and prepare audit teams well in advance with mock audits.
Challenge: Incomplete or inconsistent documentation leading to multiple rounds of queries.
Solution: Utilize expert regulatory consultants and refer to detailed guides such as our MD9 License Guide to ensure compliance.
Challenge: Product testing failures or delays.
Solution: Select CDSCO-approved accredited testing labs listed on the official testing laboratories page and conduct pre-tests internally before submitting samples.
Expert Consultation and Support
Navigating the intricacies of CDSCO licensing for a Class C device like the dental bone matrix implant demands specialized expertise. We have successfully supported over 500 companies in obtaining timely MD9 manufacturing and MD15 import licenses, ensuring smooth product launches in India.
Our consultation includes:
- Gap analysis of existing documentation
- Preparation and review of Device and Plant Master Files
- Mock audits and compliance training
- Coordination with notified bodies and CDSCO officials
- End-to-end application submission and query management
Feel free to reach out for tailored support to accelerate your CDSCO licensing journey.
Getting Started with Your CDSCO License Application
To initiate your licensing process for dental bone matrix implants:
- Register on the CDSCO MD Online Portal.
- Apply for the Test License (Form MD13) to manufacture samples for testing.
- Coordinate with CDSCO-approved testing laboratories to schedule product evaluations.
- Prepare comprehensive documentation including DMF, PMF, Risk Management File, and QMS.
- Submit manufacturing license application (Form MD7) once test license and testing are complete.
- Prepare for CDSCO audit by reviewing your quality systems and facility compliance.
- Engage with regulatory experts to handle queries and expedite approvals.
Embarking on this structured approach ensures compliance with Indian medical device regulations and positions your dental bone matrix implant favorably in the market. Our decades of experience stand ready to assist you every step of the way.
