CDSCO License for Transmandibular implant
Medical Device Information
Intended Use
A sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible.
Comprehensive Guide to CDSCO Licensing for Transmandibular Implant (Class C Dental Device)
Introduction: Understanding the Transmandibular Implant and Its Regulatory Importance
The Transmandibular Implant (TMI) is a sophisticated sterile transosteal device designed for surgical implantation through the mandibular bone. Its primary function is to provide structural support and retention for dental prostheses, particularly for patients with severely atrophied or deformed mandibles. Given its invasive application and critical role in oral rehabilitation, this device falls under Class C risk category as per CDSCO's medical device classification.
As an expert regulatory consultancy with over 25 years of experience and having supported more than 500 companies in navigating the CDSCO licensing landscape, we recognize the unique challenges manufacturers and importers face with Class C devices like the TMI. This guide provides a detailed, actionable roadmap—from understanding regulatory frameworks to practical tips for a smooth application process.
CDSCO Regulatory Framework for Transmandibular Implants
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India, including Class C devices such as the Transmandibular Implant. The regulatory framework ensures safety, efficacy, and quality by mandating rigorous testing, documentation, and inspections before market authorization.
The TMI is notified under the dental devices category as per Notification No. 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. This mandates adherence to the MD9 manufacturing license pathway for Class C devices, administered by the Central Licensing Authority.
Risk Classification and License Requirements for Transmandibular Implant
- Risk Class: C (moderate to high risk)
- License Type: MD9 (Manufacturing License for Class C and D devices)
- Authority: Central Licensing Authority (CDSCO HQ)
- Application Form: MD7 for manufacturing license
Class C devices like TMI require more stringent controls than Class A/B devices. This includes product testing in government-approved labs, audit inspections by CDSCO officials, and comprehensive quality management systems.
Manufacturing License Process (MD9) for Transmandibular Implant
The manufacturing license process for a Class C device involves multiple coordinated steps:
Test License Application (Form MD13): Initially, manufacturers must obtain a test license to produce limited quantities for testing purposes. This step typically takes 1.5 to 2 months.
Product Testing: Samples must be tested at government-approved laboratories to verify compliance with applicable Indian standards and Essential Principles.
Documentation Preparation: Prepare and compile all required documents, including technical files, quality systems, and risk management documentation.
License Application Submission (Form MD7): Submit the manufacturing license application for MD9 through the CDSCO MD Online Portal.
Audit by CDSCO Inspectors: The Central Licensing Authority conducts an on-site inspection to verify compliance with GMP and QMS requirements.
Query Resolution: Address any clarifications or deficiencies raised during audit or review.
Grant of Manufacturing License (Form MD9): Upon satisfactory compliance, the license is granted.
Manufacturing License Documents Required for MD9 Application
For the Transmandibular Implant, manufacturers must prepare the following documentation meticulously:
- Company Constitution Documents: Incorporation certificate, memorandum & articles of association
- Proof of Ownership or Lease of Manufacturing Premises: Rent agreement or ownership documents
- Technical Staff Qualification and Experience: CVs and appointment letters of key personnel
- Fire NOC and Pollution Control NOC: Compliance certificates from local authorities
- Device Master File (DMF): Detailed design, manufacturing process, and specifications (Device Master File Guide)
- Plant Master File (PMF): Facility layout, equipment details, and quality control measures (Plant Master File Guide)
- Essential Principles Checklist: Declaration of conformity to CDSCO Essential Principles
- Risk Management File: Comprehensive risk analysis and mitigation measures (Risk Management)
- Test Reports: From CDSCO-recognized laboratories (Testing Laboratories)
- Labels and Instructions for Use (IFU): Samples showing compliance with labeling regulations
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and SOPs
Import License Process (MD15) for Transmandibular Implant
For importers intending to bring the Transmandibular Implant into India, the MD15 import license is mandatory, granted by the Central Licensing Authority. The process includes:
Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
Queries and Clarifications: Respond promptly to any departmental queries.
Grant of Import License: Upon satisfactory review, the MD15 license is issued.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File & Plant Master File
- Wholesale License for distribution
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Documentation Preparation | 3 – 4 weeks |
| MD9 License Application Processing | 2 – 3 months |
| Total Timeline | 4 – 5 months |
For imports:
| Process Step | Duration (Approx.) |
|---|---|
| Documentation Preparation | 4 – 6 weeks |
| MD15 License Application Processing | 4 – 5 months |
| Total Timeline | 5 – 6 months |
Government Fees and Costs
For manufacturing the Transmandibular Implant (Class C device):
- Application Fee: Rs. 50,000 per application
- Product Fee: Rs. 1,000 per product
For import license (MD15):
- Site Fee: USD 3,000 per site
- Product Fee: USD 1,500 per product
Additional costs to budget for include:
- Testing laboratory fees (varies by lab and tests required)
- Audit fees (if engaging notified bodies or consultants)
- Preparation of technical documentation
Common Challenges and Solutions
Challenge: Delays in test license approval and product testing.
Solution: Engage early with government-approved testing laboratories and submit accurately completed test license applications to avoid back-and-forth.
Challenge: Incomplete documentation leading to queries.
Solution: Utilize our detailed document checklist and ensure all files—especially Device Master File, Risk Management, and QMS documents—are thorough and up-to-date.
Challenge: Audit non-compliance issues.
Solution: Conduct a pre-audit internal review aligning with CDSCO GMP and ISO 13485 standards.
Challenge: Navigating complex import license fees and documentation.
Solution: Partner with regulatory experts who understand CDSCO nuances and can streamline the import licensing process.
Expert Consultation and Support
Our extensive experience with over 500 successful CDSCO licenses positions us uniquely to guide you through every step of the regulatory journey for your Transmandibular Implant. From document preparation to audit readiness and query management, our expert team ensures compliance with minimal delays.
We also help you connect with accredited notified bodies for audits and coordinate with government testing laboratories, ensuring seamless progress.
Explore our detailed MD9 License Guide for deeper insights.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm that your Transmandibular Implant is Class C under CDSCO guidelines. Use tools like the Medical Device Classification guide.
Initiate Test License (MD13) Application: Prepare test license documents and submit via the CDSCO MD Online Portal.
Engage a CDSCO-Recognized Testing Laboratory: Schedule product testing early to avoid bottlenecks.
Compile Comprehensive Documentation: Begin assembling your Device Master File, Plant Master File, and Risk Management File according to regulatory expectations.
Plan for CDSCO Audit: Prepare your facility and QMS for inspection.
Submit Manufacturing License Application (MD7): Once testing and documentation are in place, apply for your MD9 license.
Monitor Application Progress and Respond Promptly: Address queries quickly to expedite approval.
By following these structured steps and leveraging expert regulatory support, manufacturers and importers can efficiently secure their CDSCO license for Transmandibular Implants, enabling timely access to the Indian market with full compliance.
For personalized assistance, contact our regulatory consultancy team today to kickstart your CDSCO licensing journey for your Transmandibular Implant device.
