CDSCO License for Coronary artery brachytherapy system applicator, manual- afterloading
Medical Device Information
Intended Use
A sterile flexible tube intended to deliver/remove radiation therapy sources into a coronary artery, typically into the lumen of an implanted stent, as part of a manual-afterloading brachytherapy system. It is introduced into the patient and subsequently connected to the brachytherapy system source transfer device; it includes radiopaque markers to monitor the position of the radiation source. Disposable devices associated with the procedure may be included (e.g., syringe, connectors). This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Coronary Artery Brachytherapy System Applicator (Manual-Afterloading)
Navigating the regulatory landscape for high-risk medical devices in India can be complex. With over 25 years of experience assisting 500+ manufacturers and importers, we provide you with expert insights on obtaining the CDSCO license for your Class D Coronary Artery Brachytherapy System Applicator— a critical oncology device used in delivering targeted radiation therapy within coronary arteries.
Understanding Your Device and Regulatory Importance
The Coronary Artery Brachytherapy System Applicator (manual-afterloading) is a sterile, single-use, flexible tube designed to deliver radiation sources precisely into a coronary artery, typically within an implanted stent. Due to its direct application in oncology and cardiac interventions, it falls under Class D, the highest risk category as per CDSCO classification. This classification mandates stringent regulatory controls to ensure patient safety and device efficacy.
Given the device’s complexity and risk profile, obtaining the correct CDSCO license is essential before manufacturing or importing this device into India. Compliance ensures market access and builds trust with healthcare providers and patients.
CDSCO Regulatory Framework for Coronary Artery Brachytherapy System Applicator
The Central Drugs Standard Control Organisation (CDSCO) governs medical device approvals in India. For Class D devices like the coronary artery brachytherapy applicator, the regulatory oversight is centralized, requiring a license issued by the Central Licensing Authority.
The key regulatory steps include:
- Obtaining a Test License (Form MD13) to conduct product testing
- Product testing in government-approved laboratories
- Documentation preparation including Device Master File (DMF) and Plant Master File (PMF)
- Submission of the Manufacturing License Application (Form MD7) for an MD9 license
- Inspection and audit by CDSCO officials
- Query resolution and final license grant (Form MD9)
Risk Classification and License Requirements
As a Class D medical device, the Coronary Artery Brachytherapy System Applicator requires an MD9 Manufacturing License. This license is mandatory for manufacturing Class C and D devices within India and is issued by the CDSCO Central Licensing Authority.
If you are an importer, an MD15 Import License is required from the Central Licensing Authority for Class D devices.
Manufacturing License Process (MD9) for Class D Devices
The manufacturing license process for Class D devices involves several critical steps:
Apply for a Test License (Form MD13): This allows product testing in CDSCO-approved labs. The test license process usually takes 1.5 to 2 months.
Product Testing: Testing must be conducted in laboratories notified by CDSCO to ensure compliance with essential principles. You can find the list of approved testing laboratories to select an appropriate facility.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System documents.
Submit MD9 Application (Form MD7): Apply through the CDSCO MD Online Portal with all requisite documents.
CDSCO Audit and Inspection: CDSCO officials conduct a detailed audit of your manufacturing site and documentation.
Query Resolution: Address any queries or observations raised by the CDSCO or audit team.
Grant of MD9 License: Upon successful review, the CDSCO issues the manufacturing license (Form MD9).
Manufacturing License Documents Required
For the Coronary Artery Brachytherapy System Applicator, prepare the following documents meticulously to avoid delays:
- Company Constitution Documents: Certificate of incorporation, partnership deed, or equivalent
- Proof of Ownership or Rent Agreement: For the manufacturing premises
- Technical Staff Details: Qualifications and experience certificates
- Fire and Pollution NOCs: From local authorities
- Device Master File (DMF): Detailed design, manufacturing process, and safety data (See our DMF guide)
- Plant Master File (PMF): Manufacturing facility details (Learn more)
- Essential Principles Checklist: Compliance with Indian medical device regulations
- Risk Management File: Documentation of identified risks and mitigation strategies (Risk management info)
- Test Reports: From CDSCO-approved laboratories
- Labels and Instructions for Use (IFU): Device labeling and user manuals
- Quality Management System (QMS) Documents: ISO 13485 certification and procedures
Import License Process (MD15) for Class D Devices
If you plan to import the Coronary Artery Brachytherapy System Applicator, the import license process is as follows:
Document Preparation: Including valid Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, wholesale license, and company constitution.
Submit Application (Form MD14) for MD15 License: Apply via the CDSCO MD Online Portal.
Queries Resolution: Respond to any CDSCO queries promptly.
License Grant: Upon approval, CDSCO issues the Import License (Form MD15).
Import License Documents Required
- Valid manufacturing license from country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File (DMF)
- Plant Master File (PMF)
- Wholesale license for import
- Company constitution and ownership proof
Timeline and Processing Duration
| License Type | Typical Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| MD9 Manufacturing License | 4 to 5 months (including test license and audit) |
| MD15 Import License | 5 to 6 months |
For Class D devices, the entire manufacturing license process from test license application to final grant typically spans 4-5 months. Import licenses generally take 5-6 months.
Government Fees and Costs
- MD9 Manufacturing License: Rs. 50,000 per application + Rs. 1,000 per product
- Test License (MD13): Nominal fees applicable
- MD15 Import License:
- Class C & D devices: 1,500 per product
These fees are payable via the CDSCO portal during application submission.
Common Challenges and Practical Solutions
Challenge: Delays in testing due to limited CDSCO-approved labs.
Solution: Plan testing early and select labs from the official notified list. Maintain continuous communication with lab officials.
Challenge: Incomplete or inconsistent documentation leading to query cycles.
Solution: Use checklists and expert consultation to prepare comprehensive documentation. Refer to our detailed MD9 License Guide for document preparation.
Challenge: Audit non-compliance due to facility gaps.
Solution: Conduct internal audits before CDSCO inspection. Ensure your QMS and plant facilities meet CDSCO standards.
Expert Consultation and Support
Navigating CDSCO regulatory requirements for a Class D oncology device demands expert knowledge and precise execution. With our 25+ years’ experience and a track record of 500+ successful client licenses, we offer:
- End-to-end application preparation
- Document and quality system gap analysis
- Coordination with notified bodies and testing labs
- Training and audit readiness
Our proactive approach minimizes delays and accelerates your pathway to market.
Getting Started with Your CDSCO License Application
To initiate your CDSCO licensing journey for the Coronary Artery Brachytherapy System Applicator:
- Assess your device classification: Confirm Class D status and corresponding license type.
- Register on the CDSCO MD Online Portal: Create your company profile.
- Apply for Test License (MD13): Prepare preliminary documents and submit.
- Schedule product testing: Choose a CDSCO-approved lab early.
- Prepare comprehensive documentation: DMF, PMF, risk management, and more.
- Submit MD9 application (Form MD7): Once test reports are ready.
- Prepare for CDSCO audit: Ensure your manufacturing site and QMS are compliant.
- Respond promptly to queries: Maintain open communication with CDSCO.
Starting early and leveraging expert guidance can significantly streamline your pathway to a successful license grant. Reach out to our regulatory consultants today to craft a tailored strategy for your Coronary Artery Brachytherapy System Applicator's CDSCO approval.
Embark on your CDSCO licensing journey with confidence, backed by decades of expertise and a deep understanding of India’s medical device regulatory ecosystem.
