CDSCO License for Applicator for brachytherapy non- central circulatory general-purpose manual
Medical Device Information
Intended Use
A general-purpose brachytherapy applicator used to facilitate radiotherapy. A single or module applicator designed to facilitate manual placement (puncture, local placement, placement under endoscopy, and placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the non-central circulatory system.
Introduction to Applicator for Brachytherapy Non-Central Circulatory General-Purpose Manual and Its Regulatory Importance
The Applicator for brachytherapy non-central circulatory general-purpose manual is a critical medical device designed to assist in precise radiotherapy treatments. Specifically, this device facilitates the manual placement of therapeutic radiation sources in non-central circulatory system sites, ensuring effective and targeted cancer treatment. Given its specialized function and patient safety implications, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) standards is essential for manufacturers and importers aiming to market this device in India.
Navigating CDSCO regulations is not just a legal requirement but a strategic step towards ensuring device safety, efficacy, and market credibility. With over 25 years of experience and having supported 500+ companies, we understand the nuances involved in securing the necessary licenses efficiently.
CDSCO Regulatory Framework for Radiotherapy Applicators (Class C Medical Devices)
The CDSCO classifies medical devices based on risk, with Class C representing moderate to high risk. The Applicator for brachytherapy falls under this category due to its direct involvement in radiotherapy treatment. As per CDSCO notification File No. 29/Misc./03/2020-DC (180) dated 6.8.2021, this device requires a Central Licensing Authority approval through an MD9 license.
The regulatory framework mandates stringent quality, safety, and performance evaluations, including comprehensive documentation, product testing from government-approved labs, and regulatory audits.
Risk Classification and License Requirements for Class C Devices
Class C devices like the brachytherapy applicator require an MD9 manufacturing license issued by CDSCO’s Central Licensing Authority. This license ensures that the manufacturing process adheres to national standards and the device meets the Essential Principles of Safety and Performance.
Key points regarding the MD9 license:
- Issued by the Central Licensing Authority
- Mandatory product testing and audit by CDSCO inspectors
- Valid for manufacturing and marketing within India
For detailed classification guidance, consult the Medical Device Classification resource.
Manufacturing License Process (MD9) for Class C Brachytherapy Applicator
The MD9 license process involves multiple steps, typically spanning 4 to 5 months:
Test License Application (Form MD13): The initial step involves obtaining a test license to manufacture the device prototype for testing purposes. This phase lasts approximately 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved government laboratories to validate safety and performance. Refer to the Testing Laboratories list.
Documentation Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist is prepared.
License Application Submission (Form MD7): Apply for the MD9 license using Form MD7 via the CDSCO MD Online Portal.
Regulatory Audit: CDSCO inspectors conduct an on-site audit to verify compliance with Good Manufacturing Practices (GMP).
Query Resolution: Address any observations or queries raised by the CDSCO or notified bodies promptly.
Grant of License (Form MD9): Upon satisfactory completion of all steps, the manufacturing license is granted.
For an in-depth understanding, refer to our MD9 License Guide.
Manufacturing License Documents Required for MD9 Application
Accurate and complete documentation is crucial to avoid delays. The required documents for the brachytherapy applicator MD9 license include:
- Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association
- Proof of Ownership/Lease of Manufacturing Premises
- Technical Staff Credentials: Qualification and experience certificates of manufacturing and quality personnel
- Fire NOC and Pollution Control Board NOC: Compliance with local environmental and safety regulations
- Device Master File (DMF): Detailed device specifications, design, and manufacturing processes. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Documentation of manufacturing facilities and equipment. See our Plant Master File guide.
- Essential Principles Checklist: Compliance with CDSCO Essential Principles for medical devices
- Risk Management File: Documentation of identified risks and mitigation strategies, compliant with ISO 14971. For practical implementation, visit our Risk Management resource.
- Product Test Reports: From CDSCO-approved laboratories
- Labels and Instructions for Use (IFU): As per Indian regulations
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs
Ensuring these documents are prepared accurately streamlines the audit and approval process.
Import License Process (MD15) for Class C Devices
For companies importing the brachytherapy applicator into India, the MD15 import license is mandatory. This license is granted by the Central Licensing Authority and typically takes 5 to 6 months.
Process overview:
- Document preparation including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Application submission on the CDSCO MD Online Portal
- Query resolution and verification
- License grant in Form MD15
Required documents include manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files, Wholesale License, and Company Constitution documents.
Refer to our detailed Import License Guide for step-by-step assistance.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Documentation Preparation | 2 to 4 weeks |
| Application Review & Audit | 1.5 to 2 months |
| Total (MD9 License) | Approximately 4-5 months |
Careful planning and early submission of documents can help in meeting these timelines effectively.
Government Fees and Costs
The fee structure for Class C devices is as follows:
- MD9 License: Rs 50,000 per application + Rs 1,000 per product
- Test License (MD13): Included in the overall process
- Product Testing: Costs vary depending on the number of tests; budget accordingly
These fees are payable through the CDSCO portal during the application process.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Plan testing well in advance and choose CDSCO-approved labs listed here.
Challenge 2: Incomplete Documentation
- Solution: Use our detailed checklists for Device Master File and Plant Master File to avoid missing critical documents.
Challenge 3: Audit Non-compliance
- Solution: Conduct internal audits and gap assessments prior to CDSCO inspection.
Challenge 4: Query Resolution Delays
- Solution: Assign experienced regulatory professionals for prompt and accurate responses.
Expert Consultation and Support
With over two decades of expertise and more than 500 successful CDSCO licensing projects, we provide:
- Comprehensive gap analysis
- Documentation support and preparation
- Coordination with notified bodies and CDSCO authorities
- Training for audit readiness
- Post-licensing compliance assistance
Our proven methodologies reduce approval timelines and mitigate regulatory risks.
Getting Started with Your CDSCO License Application for the Brachytherapy Applicator
- Evaluate Your Device Classification: Confirm the Class C status and understand the implications.
- Engage a Regulatory Consultant: Early engagement helps in navigating complex requirements.
- Prepare Required Documents: Begin compiling company, technical, and device-specific documentation.
- Apply for Test License (MD13): Submit your initial application via the CDSCO MD Online Portal.
- Plan Product Testing: Coordinate with government-approved labs immediately after test license approval.
- Prepare for Audit: Develop robust QMS and conduct mock audits.
- Submit MD9 License Application (Form MD7): Once all prerequisites are met.
Your successful market entry starts with meticulous planning and expert guidance. Reach out to us to leverage our regulatory expertise for your brachytherapy applicator licensing needs.
