CDSCO License for Alternating electric field antimitotic cancer treatment system transducer array
Medical Device Information
Intended Use
Alternating electric fields therapy is a novel anticancer treatment that disrupts tumor cell mitosis.
Introduction to Alternating Electric Field Antimitotic Cancer Treatment System
The Alternating Electric Field Antimitotic Cancer Treatment System Transducer Array represents a cutting-edge oncology medical device designed to disrupt tumor cell mitosis using alternating electric fields therapy. This novel anticancer treatment offers a promising alternative or adjunct to traditional therapies, making it a significant advancement in cancer care. Given its innovative nature and critical clinical application, obtaining the appropriate regulatory approval from CDSCO is essential for manufacturers and importers aiming to enter the Indian market.
CDSCO Regulatory Framework for Class C Oncology Devices
In India, the Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices to ensure safety, quality, and efficacy. Devices like the Alternating Electric Field Antimitotic Cancer Treatment System fall under Class C due to their higher risk profile, as specified in the Medical Device Classification.
Class C devices include those critical for life-support or life-sustaining functions, or devices that have a substantial impact on patient health. Therefore, the licensing process is managed by the Central Licensing Authority, with stringent requirements for manufacturing and import.
Risk Classification and License Requirements for Class C Devices
Our extensive experience with over 500 successful CDSCO license applications confirms that Class C devices require an MD9 manufacturing license (Form MD7) for domestic manufacturing and an MD15 import license for foreign manufacturers or importers.
Key Points:
- License Type: MD9 for manufacturing, MD15 for import
- Authority: Central Licensing Authority (CDSCO HQ)
- Typical Timeline: 4-5 months for MD9; 5-6 months for MD15
- Fees: Rs 50,000 + Rs 1,000 per product for MD9; USD 3,000 + USD 1,500 per product for MD15
Manufacturing License Process (MD9) for Class C Devices
Test License Acquisition: Begin with a Test License under Form MD13, valid for 3 years. This step typically takes 1.5 to 2 months. It allows you to legally manufacture the device for testing purposes.
Product Testing: Obtain testing from CDSCO-approved laboratories to ensure compliance with Indian standards. Refer to the Testing Laboratories list for accredited facilities.
Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Application Submission: File the MD9 license application via the CDSCO MD Online Portal using Form MD7.
Audit and Inspection: CDSCO inspectors will conduct a thorough audit of your manufacturing facility and QMS compliance.
Query Resolution: Address any queries raised by CDSCO during the evaluation.
License Grant: Upon successful review, the MD9 manufacturing license is granted.
For detailed guidance, see our MD9 License Guide.
Manufacturing License Documents Required for MD9
- Company Constitution or 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 — detailed device specifications and manufacturing process (Device Master File Guide)
- Plant Master File — manufacturing environment and process controls (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating compliance with ISO 14971 (Risk Management)
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documents compliant with ISO 13485:2016
Import License Process (MD15) for Class C Devices
For companies importing the Alternating Electric Field Antimitotic Cancer Treatment System into India, the MD15 import license is mandatory. Unlike manufacturing, no test license is required.
Document Compilation: Gather all necessary documents, including the manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, Device Master File, and Plant Master File.
Application Submission: Submit the application on the CDSCO MD Online Portal using Form MD14.
Query Resolution: Respond promptly to any CDSCO queries.
License Issuance: MD15 license is granted upon satisfactory document review.
Refer to our Import License Guide for detailed assistance.
Import License Documents Required for MD15
- Valid manufacturing license from the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution
- Product labels and IFU
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 1 month |
| Application Review & Audit | 1 - 1.5 months |
| Query Resolution | 2 - 4 weeks |
| Total (MD9 License) | 4 - 5 months |
| Application Review (MD15) | 5 - 6 months |
Timelines can vary depending on the completeness of documentation and responsiveness to queries.
Government Fees and Costs
MD9 Manufacturing License Fees (Class C):
- Application Fee: Rs 50,000
- Per Product Fee: Rs 1,000
MD15 Import License Fees (Class C):
- Site Fee: USD 3,000
- Per Product Fee: USD 1,500
Additional costs include testing charges at approved laboratories and audit fees charged by notified bodies or CDSCO inspectors.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all files, especially Device Master File and Risk Management File, are comprehensive and aligned with CDSCO guidelines. Use our detailed guides to avoid omissions.
- Delayed Test Reports: Plan testing early with CDSCO-approved labs to accommodate their workload. Check the Testing Laboratories list in advance.
- Audit Non-compliance: Prepare your facility and QMS thoroughly before audit. Engage with a notified body from the Notified Bodies List for pre-audit assessments.
- Slow Query Responses: Designate a dedicated team to handle CDSCO communications promptly to avoid delays.
Expert Consultation and Support
With over 25 years of experience and successful support to 500+ medical device companies, we specialize in navigating the complexities of CDSCO licensing for high-risk oncology devices like the Alternating Electric Field Antimitotic Cancer Treatment System. Our expert team can assist you with:
- Comprehensive gap analysis of your documentation
- End-to-end application preparation and submission
- Audit readiness and mock inspections
- Liaison with CDSCO and notified bodies
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your device is Class C via the Medical Device Classification guide.
Prepare Documentation: Leverage our Device Master File and Plant Master File guides to compile your files.
Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal to begin manufacturing for testing.
Engage Testing Labs: Coordinate testing with government-approved laboratories early to avoid bottlenecks.
Submit Manufacturing License Application: File Form MD7 for MD9 license with all supporting documents once test reports are in hand.
Prepare for Audit: Schedule your audit with CDSCO inspectors and ensure full compliance.
Track Application Progress: Monitor your application status online and respond to queries promptly.
Taking these actionable steps with expert guidance will streamline your path to CDSCO approval, enabling you to bring this innovative oncology therapy to Indian patients efficiently and compliantly.
