CDSCO License for MOSFET radiation therapy dosimetry system
Medical Device Information
Intended Use
An assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research.
Comprehensive CDSCO Licensing Guide for MOSFET Radiation Therapy Dosimetry Systems
As leaders in medical device regulatory consulting with over 25 years of experience and having assisted 500+ companies secure CDSCO licenses, we understand the nuanced pathway manufacturers and importers face when entering the Indian market. The MOSFET radiation therapy dosimetry system — a Class B device used extensively in radiation oncology for precise dose verification — requires careful adherence to the Central Drugs Standard Control Organization (CDSCO) regulatory framework.
Understanding the MOSFET Radiation Therapy Dosimetry System and Its Regulatory Importance
This device utilizes metal oxide semiconductor field-effect transistor (MOSFET) technology to provide immediate, in vivo radiation dose verification during therapeutic and diagnostic procedures. Applications include radiation oncology, brachytherapy, intraoperative radiation therapy, and image-guided radiation therapy. Given its critical role in patient safety and treatment accuracy, the Indian government mandates rigorous licensing under the medical device regulatory framework.
CDSCO Regulatory Framework for Radiotherapy Devices Like MOSFET Dosimetry Systems
The CDSCO classifies medical devices based on associated risk. For the MOSFET radiation therapy dosimetry system, classified as Class B (low to moderate risk), the licensing process is managed at the state level via the MD5 manufacturing license. This process ensures your device meets safety, efficacy, and quality standards before market introduction.
Risk Classification and License Requirements
- Risk Class: B (Low-moderate risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Process Duration: Approximately 3 to 4 months
You can verify the device classification and understand risk management requirements in detail via our Medical Device Classification guide and Risk Management resource.
Step-by-Step Manufacturing License Process (MD5)
- Obtain Test License (Form MD13): Initiate with a test license application, which typically takes 1.5 to 2 months to process. This allows product testing in government-approved labs.
- Product Testing: Submit your MOSFET dosimetry system to government-approved testing laboratories for compliance verification.
- Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, Quality Management System (QMS) documents, and test reports.
- Apply for MD5 License (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal, attaching all required documents.
- Audit by Notified Body: Undergo an audit by a notified body accredited for Class B audits. Refer to the Notified Bodies List to select an auditor.
- Respond to Queries: Address any queries raised by the licensing authority or notified body promptly.
- Grant of MD5 License: Upon satisfactory audit and documentation review, the license is granted, allowing you to manufacture your device legally in India.
For more detailed guidance, our MD5 License guide is an invaluable resource.
Manufacturing License Documents Required for MOSFET Dosimetry System
Ensure you have the following critical documents ready:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire Safety NOC and Pollution Control NOC
- Device Master File (DMF): Detailed design, specifications, and manufacturing process. See our Device Master File guide for preparation tips.
- Plant Master File (PMF): Manufacturing facility details and quality systems. Refer to our Plant Master File guide.
- Essential Principles Checklist and Risk Management File
- Product Test Reports from approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documentation (ISO 13485:2016 recommended)
Import License Process (MD15) for MOSFET Dosimetry Systems
If you plan to import this device rather than manufacture it domestically, you must apply for an MD15 import license through the Central Licensing Authority.
- Application Form: MD14
- Processing Time: 5 to 6 months
- Documents Required: Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
Detailed procedural insights are available in our Import License guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | Variable (2 – 4 weeks recommended) |
| Application Review & Audit | 1 – 1.5 months |
| Query Resolution | 2 – 3 weeks |
| Total Estimated Time | 3 to 4 months |
Government Fees and Costs
- Application Fee: ₹5,000 per MD5 license application
- Product Fee: ₹500 per product
- Additional costs include notified body audit fees (varies by body), testing fees at government-approved labs, and consultancy fees if applicable.
Common Challenges and Practical Solutions
- Delayed Test Reports: Opt for government-approved labs with proven turnaround times to avoid bottlenecks.
- Incomplete Documentation: Utilize checklists and professional consulting to ensure all documents, especially Device and Plant Master Files, are comprehensive and compliant.
- Audit Non-Compliance: Pre-audit internal reviews and training sessions for technical staff can mitigate non-conformities.
Expert Consultation and Support
Navigating the CDSCO licensing process for Class B devices like MOSFET radiation therapy dosimetry systems can be complex. Our extensive experience enables us to provide tailored support including audit preparation, document drafting, and liaison with CDSCO officials, ensuring a smooth and timely approval.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class B status and understand applicable requirements.
- Gather Core Documentation: Start compiling your Device Master File and Plant Master File.
- Apply for Test License (MD13): Submit early to avoid delays in the overall timeline.
- Identify Testing Laboratories: Select from the official Testing Laboratories list.
- Prepare for Manufacturing Site Audit: Coordinate with a notified body from the Notified Bodies List.
- Submit MD5 License Application: Use the CDSCO MD Online Portal for streamlined electronic submissions.
By following these actionable steps and leveraging expert guidance, manufacturers and importers can confidently enter the Indian medical device market with their MOSFET radiation therapy dosimetry systems, ensuring compliance, safety, and market success.
