CDSCO License for Extravascular-circulation hyperthermia system applicator, extracorporeal
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A vessel applied to the outside of the body (e.g., in the form of a jacket, vest, body wrap, cushion, blanket, or mattress) that incorporates tubing through which heated fluids are circulated for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. he applicator typically includes a thermometry component that monitors the temperature of the applicator during operation. The applicator includes tubing, cables, and connectors that interface with the hyperthermia system's control unit during treatments. It is typically used in an oncology department. This is a reusable device.
Introduction to Extravascular-Circulation Hyperthermia System Applicator and Its Regulatory Importance
The Extravascular-Circulation Hyperthermia System Applicator, extracorporeal, is a specialized medical device designed for oncology treatments. This device, applied externally as a jacket, vest, or blanket, circulates heated fluids to provide localized or systemic hyperthermia therapy for malignant tumors and other disease-related conditions. Equipped with thermometry to monitor temperature and reusable tubing and connectors interfacing with the control unit, it plays a crucial role in targeted cancer therapies typically administered in oncology departments.
Given its clinical significance and patient safety considerations, strict regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India is mandatory. Compliance ensures the device meets quality, safety, and efficacy benchmarks critical for market access and patient trust.
CDSCO Regulatory Framework for Extravascular Hyperthermia Applicators
CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, which classify devices into different risk categories and outline licensing pathways. For the Extravascular-Circulation Hyperthermia System Applicator, classified as Class A (low risk), the regulatory framework requires manufacturers to obtain a manufacturing license under the MD5 license category, managed by the State Licensing Authority.
The MDR emphasizes conformity to essential principles, quality management systems, and documentation, ensuring devices like this applicator are safe for repeated clinical use.
Risk Classification and License Requirements for Class A Devices
Class A devices are low-risk devices that require the MD5 manufacturing license. This license mandates compliance with the MDR 2017 provisions, including obtaining a test license (MD13), product testing from government-approved laboratories, and audits by notified bodies.
For the Extravascular Hyperthermia Applicator, which involves patient contact and therapeutic functionality, Class A classification reflects its reusable nature and relatively lower risk compared to implantable or high-risk devices.
Manufacturing and importing this device necessitates rigorous adherence to CDSCO’s documentation and process requirements to secure the license.
Manufacturing License Process for MD5 (Class A Devices)
The MD5 license process involves several critical steps:
Test License Application (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license. This step typically takes 1.5 to 2 months.
Product Testing: After receiving the test license, the device must be tested at CDSCO-approved government laboratories for compliance with relevant standards. See the list of testing laboratories for authorized facilities.
Document Preparation: Concurrently, prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) records.
Application Submission (Form MD3): Submit the manufacturing license application for MD5 via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct a plant audit to verify compliance. Refer to the list of notified bodies for audit agencies.
Queries Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant (Form MD5): Upon successful audit and documentation review, the manufacturing license is granted.
For your device, this entire process usually spans 3 to 4 months, including test license issuance and audit.
Manufacturing License Documents Required
To streamline your MD5 license application for the Extravascular Hyperthermia Applicator, ensure submission of the following key documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification Documents and Experience Certificates
- Fire Safety and Pollution NOCs
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File guide)
- Plant Master File (PMF) describing manufacturing facilities and equipment (Plant Master File guide)
- Essential Principles Checklist confirming compliance with MDR 2017
- Risk Management File demonstrating hazard identification and mitigation (Risk Management)
- Product Test Reports from government-approved labs
- Device Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485 certification preferred)
Completing and organizing these documents meticulously can significantly reduce application processing delays.
Import License Process (MD15) for Extravascular Hyperthermia Applicators
While your device is Class A and primarily requires an MD5 manufacturing license, importers seeking to bring this device into India must apply for the MD15 import license, governed by the CDSCO Central Licensing Authority.
The import license process involves:
- Preparation of comprehensive documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and wholesale license.
- Submission of the application via the CDSCO MD Online Portal.
- Resolution of any queries raised during evaluation.
- Grant of the MD15 license within 5 to 6 months.
Note that no test license is required for import applications.
Import License Documents Required
Importers must compile the following for MD15 applications:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File (DMF)
- Plant Master File (PMF)
- Wholesale Drug License
- Company Constitution Documents
Ensuring these documents are authenticated and readily available expedites the licensing process.
Timeline and Processing Duration
| License Type | Typical Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Manufacturing License (MD5) | 3 - 4 months (including test license and audit) |
| Import License (MD15) | 5 - 6 months |
For your Class A device, expect approximately 3 to 4 months from test license application to final MD5 license grant, assuming timely document submission and audit clearance.
Government Fees and Costs
| License Type | Fees |
|---|---|
| MD5 License | Rs 5,000 per application + Rs 500 per product |
| MD13 Test License | Included in MD5 process |
| MD15 Import License | Varies by class; for Class A, approx 50 per product |
Budgeting for these fees upfront avoids payment delays that can stall your application.
Common Challenges and Solutions
Incomplete Documentation: Many applicants face delays due to missing or inadequate DMF, PMF, or Risk Management files. We recommend early preparation using detailed templates and checklists.
Delayed Product Testing: Scheduling tests at government-approved labs can be time-consuming. Engaging labs early and submitting samples promptly is critical.
Audit Non-Compliance: Non-conformities during notified body audits cause significant delays. Conduct internal pre-audit assessments to ensure readiness.
Query Resolution Delays: Slow responses to CDSCO queries prolong timelines. Assign dedicated regulatory personnel to monitor and respond promptly.
Understanding MDR Updates: Regulatory changes can impact licensing requirements. Partnering with experienced consultants ensures up-to-date compliance.
Expert Consultation and Support
With over 25 years of experience and having assisted 500+ companies, we specialize in navigating the complexities of CDSCO licensing. Our end-to-end support includes:
- Tailored document preparation for your specific device
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- Strategic application submission and follow-up
Reach out to leverage our expertise and accelerate your market entry successfully.
Getting Started with Your CDSCO License Application
Evaluate Your Device Classification: Confirm Class A status using the Medical Device Classification tool.
Prepare Test License Application (MD13): Begin by submitting your test license application on the CDSCO MD Online Portal.
Organize Essential Documentation: Develop your DMF, PMF, Risk Management File, and QMS documents concurrently.
Plan Product Testing: Identify and coordinate with CDSCO-approved testing laboratories early.
Schedule Notified Body Audit: Choose an appropriate notified body from the list here and prepare for inspection.
Submit Manufacturing License Application (MD3): After completing tests and audit, apply for your MD5 manufacturing license.
Monitor Application Progress: Respond promptly to any queries or requests from CDSCO.
By following these actionable steps and engaging expert support, manufacturers of the Extravascular-Circulation Hyperthermia System Applicator can confidently navigate the CDSCO licensing landscape and successfully enter the Indian market.
