CDSCO License for Extravascular-circulation hyperthermia system
Medical Device Information
Intended Use
An assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions.
Comprehensive Guide to CDSCO Licensing for Extravascular-Circulation Hyperthermia Systems (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 medical device companies in India, we understand the critical importance of securing the right CDSCO license for your medical device. The Extravascular-circulation hyperthermia system, classified as a Class B device under CDSCO regulations, plays a vital role in oncology by enabling systemic or localized heating treatments for malignant tumors and other disease-related conditions. Successfully navigating the regulatory framework is essential to ensure timely market entry and compliance.
CDSCO Regulatory Framework for Extravascular-Circulation Hyperthermia Systems
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. Following the 2020 medical device notification, this system falls under Class B devices, which require a manufacturing license from the respective State Licensing Authority, governed by the Medical Device Rules, 2017.
The key regulatory milestones include obtaining a Test License (Form MD13), product testing by government-approved laboratories, application for the Manufacturing License (Form MD3), and an audit by a notified body.
For importers, a separate Import License (Form MD15) granted by the Central Licensing Authority is mandatory.
Risk Classification and License Requirements for Class B Oncology Devices
The Extravascular-circulation hyperthermia system is classified as Class B based on its intended use and potential risk profile. This classification mandates compliance with the MD5 licensing pathway:
- License Type: Manufacturing License (MD5)
- Application Form: MD3
- Licensing Authority: State Licensing Authority
- Timeline: Approximately 3-4 months
- Fees: Rs 5000 per application + Rs 500 per product
Understanding this classification early streamlines preparation and expectations.
Manufacturing License Process (MD5) for Class B Devices
Test License Application (Form MD13): Begin by applying for a test license to manufacture and test the device prototype. This stage takes approximately 1.5-2 months.
Product Testing: After obtaining the test license, submit your Extravascular-circulation hyperthermia system samples to government-approved testing laboratories. Ensure compliance with applicable Indian standards and essential principles.
Document Compilation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
Manufacturing License Application (Form MD3): Submit your application via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body listed on the CDSCO Notified Bodies List.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
Grant of License (Form MD5): Upon successful audit and document review, the manufacturing license is granted.
For detailed guidance on the MD5 process, refer to our MD5 License Guide.
Manufacturing License Documents Required for Extravascular-Circulation Hyperthermia Systems
- Company Constitution Documents (e.g., Incorporation Certificate)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (see our Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing site details (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File covering hazard analysis and mitigation strategies (Risk Management Guide)
- Test Reports from government-approved labs (Testing Laboratories List)
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485:2016 certification)
Import License Process (MD15) for Extravascular-Circulation Hyperthermia Systems
If you are importing this device into India, an Import License (MD15) issued by CDSCO Central Licensing Authority is required. The process takes approximately 5-6 months and involves:
- Document preparation including Manufacturing License from the exporting country, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Application submission on the CDSCO MD Online Portal
- Review and query resolution by CDSCO
- Grant of Import License (Form MD15)
Applicable government fees vary based on device class and quantity. Refer to our detailed Import License Guide for specifics.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 4 weeks |
| Manufacturing License (MD5) | 1.5 – 2 months |
| Audit and Query Resolution | 3 – 4 weeks |
| Total Estimated Duration | 3 – 4 months |
Government Fees and Costs
- Test License (MD13): Approximately Rs 2000 - Rs 5000
- Manufacturing License (MD5): Rs 5000 per application + Rs 500 per product
- Audit Fees: Varies depending on notified body
Budgeting accurately for these expenses is crucial for smooth licensing.
Common Challenges and Solutions
Document Completeness: Missing or incomplete Device Master File and Risk Management documentation often delay approvals. Engage experienced consultants or utilize our comprehensive guides for preparation.
Test Lab Delays: Government-approved labs sometimes face backlogs. Plan testing early and consider multiple labs from the Testing Laboratories List.
Audit Non-Compliance: Non-adherence to QMS or plant requirements leads to audit failures. Pre-audit assessments help mitigate this risk.
Query Resolution Delays: Prompt and thorough responses to CDSCO queries reduce overall licensing time.
Expert Consultation and Support
Our extensive experience with over 500 successful CDSCO license applications uniquely positions us to guide manufacturers and importers through every regulatory step. From document preparation to audit readiness and query management, our tailored support minimizes risks and expedites approvals.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device is Class B by reviewing the Medical Device Classification guidelines.
Prepare Preliminary Documents: Assemble your company constitution, premises proofs, and technical staff credentials.
Apply for Test License (MD13): Initiate the process by submitting your application on the CDSCO MD Online Portal.
Schedule Product Testing: Coordinate with approved labs early to avoid delays.
Develop Device and Plant Master Files: Use our guides to create compliant documentation.
Engage Notified Bodies: Identify and schedule audits with notified bodies from the official list.
Submit Manufacturing License Application: After completing testing and documentation, apply for the MD5 license.
Monitor Application Status: Regularly track progress on the CDSCO portal and prepare to address any queries.
Embarking on CDSCO licensing for your Extravascular-circulation hyperthermia system may seem complex, but with expert guidance, it becomes a structured, manageable process. Contact us today to leverage our proven expertise and accelerate your medical device’s successful entry into the Indian market.
