CDSCO License for Applicator for tongue manual brachytherapy
Medical Device Information
Intended Use
A manual brachytherapy applicator specifically designed for lingual radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the tongue and the surrounding tissues. It may be designed to be standard in configuration or to handle specific radiation sources.
Comprehensive Guide to CDSCO Licensing for Applicator for Tongue Manual Brachytherapy (Class C Device)
Navigating the Indian regulatory landscape for medical devices can be complex, especially for specialized devices like the Applicator for Tongue Manual Brachytherapy. This device, classified as Class C under the CDSCO framework, plays a critical role in targeted lingual radiation therapy by facilitating precise placement of therapeutic radiation sources. Given its specialized use in radiotherapy, obtaining the correct CDSCO license is essential for legal manufacturing and import in India.
With over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we provide you with a detailed, practical roadmap to successfully register your Applicator for Tongue Manual Brachytherapy in India.
CDSCO Regulatory Framework for Applicator for Tongue Manual Brachytherapy
The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Since the Applicator for Tongue Manual Brachytherapy is a Class C device (medium to high risk), it falls under the purview of the Central Licensing Authority. Compliance with the Medical Device Rules, 2017, is mandatory.
The regulatory pathway involves:
- Demonstrating conformity with essential principles of safety and performance
- Undertaking product testing at government-approved laboratories
- Submission of detailed technical documentation
- Undergoing a thorough audit and inspection process
This ensures the device meets Indian regulatory standards while safeguarding patient safety.
Risk Classification and License Requirements for Class C Devices
Medical devices in India are classified into four risk categories: A, B, C, and D. The Applicator for Tongue Manual Brachytherapy, due to its involvement in radiotherapy and direct contact with sensitive tissues, is designated as a Class C device.
License type: Manufacturers require an MD9 manufacturing license (Application Form MD7) granted by the Central Licensing Authority. Importers need an MD15 import license.
Our in-depth Medical Device Classification guide provides clarity on device categorization.
Manufacturing License Process (MD9) for Applicator for Tongue Manual Brachytherapy
The MD9 license process for Class C devices is comprehensive and involves multiple stages:
- Test License (Form MD13):
- Duration: 1.5 to 2 months
- Purpose: Allows initial manufacturing for sample testing
- Product Testing:
- Conducted at CDSCO-approved testing laboratories
- Testing includes biocompatibility, radiation safety, mechanical integrity, etc.
- Documentation Preparation:
- Compile technical files including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents
- Application Submission (Form MD7):
- Submit via the CDSCO MD Online Portal
- Audit and Inspection:
- Conducted by CDSCO inspectors
- Ensures compliance with Good Manufacturing Practices (GMP) and regulatory requirements
- Query Resolution:
- Address any concerns or additional information requests
- License Grant (Form MD9):
- Upon successful review and audit, the manufacturing license is issued
For a detailed walkthrough, refer to our MD9 License Guide.
Manufacturing License Documents Required for MD9
Submitting a robust and complete dossier is critical. For the Applicator for Tongue Manual Brachytherapy, the following documents must be prepared:
- Company Constitution and Registration Proof
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualifications & Experience
- Fire NOC and Pollution Control Certificates
- Device Master File (DMF): Detailed design, manufacturing, and performance data (see our DMF guide)
- Plant Master File (PMF): Manufacturing environment and process details (refer here)
- Essential Principles Checklist: Compliance with safety and performance requirements
- Risk Management File: Per ISO 14971 standards and best practices
- Test Reports: From CDSCO-recognized laboratories (testing labs list)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation: ISO 13485:2016 certification and related SOPs
Ensuring accuracy and completeness in these documents significantly expedites the approval process.
Import License Process (MD15) for Applicator for Tongue Manual Brachytherapy
If you plan to import this device into India, an MD15 import license is mandatory. The process includes:
- Document Preparation: Including existing manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and company details
- Application Submission: Using Form MD14 on the CDSCO MD Online Portal
- Review & Query Resolution: The Central Licensing Authority reviews submissions and may request clarifications
- License Issuance (Form MD15): Upon compliance, the import license is granted
The import license process typically spans 5-6 months. For more, consult our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate affirming market authorization
- ISO 13485:2016 Quality Management System certificate
- CE Certificate or equivalent international standard approval
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company constitution and registration documentation
Timeline and Processing Duration for Applicator for Tongue Manual Brachytherapy Licensing
| Process Step | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Documentation Preparation | 1 month (concurrent) |
| Submission & Review (MD9) | 1 month |
| Audit & Inspection | 1 month |
| Query Resolution | 0.5 month |
| Total Manufacturing License Duration | 4 – 5 months |
| Import License (MD15) | 5 – 6 months |
These timelines may vary depending on the completeness of the application and responsiveness during query resolution.
Government Fees and Costs
The fee structure for the MD9 manufacturing license for Class C devices is as follows:
- Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
Additional costs include testing fees at government-approved labs, audit charges (if any), and consultancy fees if you engage expert assistance.
For import licenses (MD15), fees vary by class and product count; Class C devices typically incur ₹3,000 per site and ₹1,500 per product.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or non-compliance in QMS
Solution: Engage experienced consultants early, perform thorough internal audits, and prepare documents meticulously. Utilize our Plant Master File guide to ensure manufacturing compliance.
Challenge: Extended testing timelines or test failures
Solution: Pre-validate your product via internal testing and choose CDSCO-approved testing laboratories with expertise in radiotherapy devices.
Challenge: Audit non-conformities
Solution: Conduct mock audits and train your staff on regulatory expectations. Understanding notified body requirements is critical—see the list of notified bodies.
Expert Consultation and Support
With vast experience in CDSCO licensing, we provide end-to-end support—from test license application to audit readiness and final license grant. Our team helps:
- Prepare comprehensive technical files
- Liaise with CDSCO and notified bodies
- Manage testing and audit schedules
- Resolve regulatory queries promptly
Partnering with regulatory experts reduces time-to-market and prevents costly compliance pitfalls.
Getting Started with Your CDSCO License Application for Applicator for Tongue Manual Brachytherapy
- Confirm your device classification: Verify Class C designation.
- Initiate Test License Application (Form MD13): Begin manufacturing samples for testing.
- Select Government-Approved Testing Labs: Coordinate product testing early.
- Prepare Technical Documentation: Device Master File, Plant Master File, Risk Management, QMS documents.
- Submit Manufacturing License Application (Form MD7) via the CDSCO MD Online Portal.
- Prepare for Audit: Schedule and conduct inspections with CDSCO officials.
- Address any Queries Promptly: Maintain transparent communication.
- Obtain MD9 Manufacturing License: Begin full-scale production upon approval.
For imports, follow the import license (MD15) process similarly.
Starting early and adhering to regulatory requirements ensures a smooth approval journey. Our proven track record and deep understanding of CDSCO procedures position us as your ideal regulatory partner.
Navigating the CDSCO licensing for the Applicator for Tongue Manual Brachytherapy requires strategic planning, detailed documentation, and regulatory expertise. Leveraging our 25+ years of experience can save you time, resources, and hassle—enabling you to bring this vital radiotherapy device to patients in India safely and compliantly.
