CDSCO License for Transgingival implant
Medical Device Information
Intended Use
A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.
Comprehensive Guide to CDSCO Licensing for Transgingival Implants (Class C Medical Device)
Transgingival implants are specialized dental devices surgically implanted through the oral mucosa and gingiva to support dental prostheses. Given their invasive nature and direct contact with bone and mucosal tissues, these implants are classified as Class C medical devices under the Indian regulatory framework. Navigating the Central Drugs Standard Control Organisation (CDSCO) licensing process for such devices can be complex, but with over 25 years of experience assisting 500+ companies, we provide you with clear, actionable guidance tailored specifically for transgingival implants.
CDSCO Regulatory Framework for Transgingival Implants
In India, the CDSCO regulates medical devices under the Medical Device Rules, 2017. Transgingival implants fall under the dental category and are notified under the reference 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. Being Class C devices, they require central government approval for manufacturing and import licensing to ensure patient safety and compliance with quality standards.
Risk Classification and License Requirements for Transgingival Implants
The risk classification system categorizes devices based on their intended use and risk profile:
- Class A & B: Low to moderate risk
- Class C & D: Moderate to high risk
Transgingival implants are Class C, necessitating the MD9 Manufacturing License for domestic manufacturers and MD15 Import License for importers.
| License Type | Application Form | Licensing Authority | Approximate Timeline | Fees (INR) |
|---|---|---|---|---|
| MD9 Manufacturing | MD7 | Central Licensing Authority | 4-5 months | ₹50,000 + ₹1,000 per product |
| MD15 Import | MD14 | Central Licensing Authority | 5-6 months | 1,500 per product |
Detailed Manufacturing License Process (MD9) for Transgingival Implants
Obtain Test License (Form MD13): Before applying for MD9, an applicant must secure a Test License, valid for 1.5-2 months. This initial step allows the device to undergo necessary testing.
Product Testing: Testing must be conducted at CDSCO-approved laboratories. You can find the list of authorized Testing Laboratories on the CDSCO MD Online portal.
Document Preparation and Submission: Compile detailed documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and other technical files.
Application Submission: Submit the manufacturing license application via the CDSCO MD Online Portal using Form MD7.
Audit Inspection: CDSCO inspectors conduct an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and quality systems.
Query Resolution: Address any queries raised by CDSCO promptly to avoid delays.
License Grant: Upon satisfactory review, CDSCO grants the MD9 license.
For detailed guidance, refer to our MD9 License Guide.
Manufacturing License Documents Required
To ensure a smooth application process, prepare the following documents meticulously:
- Company Constitution and Incorporation Certificate
- Proof of Ownership/Lease of Manufacturing Premises
- List and Qualification Documents of Technical Staff
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, materials, and manufacturing process (DMF Guide)
- Plant Master File (PMF) describing the manufacturing facility (PMF Guide)
- Essential Principles Checklist ensuring compliance with safety and performance standards
- Risk Management File aligned with ISO 14971 (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation (ISO 13485:2016 compliance)
Import License Process (MD15) for Transgingival Implants
Importers of transgingival implants must apply for the MD15 license granted by the Central Licensing Authority:
Document Compilation: Prepare comprehensive documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, CE Certificate, Device and Plant Master Files, and ISO 13485 certification.
Application Submission: File Form MD14 through the CDSCO MD Online Portal.
Query Handling: Promptly respond to any department queries.
License Issuance: Upon approval, the MD15 license is granted.
For a step-by-step import license guide, consult our Import License Guide.
Import License Documents Required
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution
- Product Labels and IFU
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| Manufacturing License (MD9) Processing | 2 to 3 months |
| Import License (MD15) Processing | 5 to 6 months |
Note: Timelines may vary based on query response times and audit scheduling.
Government Fees and Costs Breakdown
MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
MD15 Import License:
- Site Fee: $3,000 (approx ₹2,40,000 INR)
- Per Product Fee: $1,500 (approx ₹1,20,000 INR)
Additional costs include testing fees at approved labs and audit fees charged by notified bodies.
Common Challenges and Practical Solutions
- Delayed Testing Results: Pre-schedule tests with CDSCO-approved labs to avoid bottlenecks.
- Incomplete Documentation: Use detailed checklists and templates for DMF and PMF preparation.
- Audit Non-Compliance: Conduct internal mock audits to prepare for CDSCO inspections.
- Query Management: Assign a dedicated regulatory liaison to ensure timely and accurate responses.
Expert Consultation and Support
With extensive experience advising over 500 clients in the dental device sector, our team offers tailored consultancy services. From initial classification to final license grant, we assist with documentation, liaison with CDSCO, and compliance audits to streamline your journey.
Getting Started with Your CDSCO License Application for Transgingival Implants
Assess Device Classification: Confirm your device's classification as Class C using the Medical Device Classification tool.
Prepare Essential Documentation: Begin compiling your Device Master File and Plant Master File using our comprehensive guides.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.
Schedule Testing and Audit: Coordinate with notified bodies listed on the CDSCO portal (Notified Bodies List) to plan audits post-testing.
Submit Manufacturing License Application: Complete and submit Form MD7 for MD9 manufacturing license.
For Importers: Compile required foreign regulatory documents and submit MD15 application (Form MD14).
By following this structured approach tailored specifically for transgingival implants, manufacturers and importers can significantly improve their chances of timely license approval and successful market entry into India.
For personalized assistance or detailed regulatory support, contact our expert team to leverage 25+ years of CDSCO licensing experience.
Note: All costs and timelines are indicative and subject to change based on CDSCO updates and specific case circumstances.
