Logo
Chat on WhatsApp

CDSCO License for Alternating electric field antimitotic cancer treatment system

Medical Device Information

Device Class
Class D

Intended Use

An assembly of portable devices designed to apply low-intensity, intermediate-frequency (100-300 kHz) alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically  glioblastoma multiforme (GBM) [malignant brain tumour].

Manufacturing License
MD9
Import License
MD15
CDSCO License for Alternating electric field antimitotic cancer treatment system

Understanding the Alternating Electric Field Antimitotic Cancer Treatment System and Its Regulatory Importance

The Alternating Electric Field Antimitotic Cancer Treatment System represents a cutting-edge oncology device designed specifically to treat aggressive brain cancers such as glioblastoma multiforme (GBM). This portable assembly applies low-intensity, intermediate-frequency (100–300 kHz) alternating electric fields to disrupt cancer cell mitosis, offering an innovative therapeutic approach for recurrent or newly diagnosed tumors.

Given its critical application and high-risk nature, this device falls under Class D according to the Central Drugs Standard Control Organisation (CDSCO) classification. This mandates rigorous regulatory compliance to ensure patient safety and clinical efficacy before market entry in India.

With over 25 years of experience assisting 500+ companies through the CDSCO licensing pathway, we provide you with a comprehensive roadmap tailored to this device category, helping you navigate complexities from application to approval.

CDSCO Regulatory Framework for Class D Oncology Devices

Oncology devices like the Alternating Electric Field Antimitotic Cancer Treatment System are regulated under the Medical Device Rules (MDR), 2017, as amended. Class D devices are considered high risk due to their direct impact on patient life and require central licensing authority approval via an MD9 license.

The regulatory framework includes:

  • Submission of technical documentation demonstrating safety and performance
  • Mandatory product testing in CDSCO-approved labs
  • On-site inspections and audits by CDSCO officials
  • Compliance with quality management systems aligned with ISO 13485:2016

For a detailed understanding of device classification, you can refer to our Medical Device Classification guide.

Risk Classification and License Requirements for This Device

Our device is classified as Class D due to:

  • Its use in oncology for treating malignant brain tumors
  • High potential risk to patients if not properly manufactured or used

Accordingly, manufacturers must obtain an MD9 license granted by the Central Licensing Authority (CDSCO HQ). This license requires compliance with stringent documentation, testing, and audit protocols.

Manufacturing License Process for MD9 (Class D Devices)

The manufacturing license process for Class D devices involves multiple stages:

  1. Test License Application (Form MD13): Before full license application, a test license is mandatory to allow sample testing. This takes approximately 1.5 to 2 months.
  2. Product Testing: Conducted at government-approved laboratories to validate safety and efficacy. Testing duration varies based on test scope.
  3. Preparation of Comprehensive Documentation: Including Device Master File, Plant Master File, Risk Management File, and QMS documentation.
  4. Application Submission (Form MD7): Submit the manufacturing license application for MD9 via the CDSCO MD Online Portal.
  5. Audit by CDSCO Inspectors: Physical inspection of manufacturing premises and process audit.
  6. Query Resolution: Address any observations or deficiencies raised by the authority.
  7. Grant of MD9 License: Upon satisfactory compliance, the license is issued.

This entire process typically spans 4 to 5 months from start to finish.

For a step-by-step guide, our MD9 License Guide offers detailed insights.

Manufacturing License Documents Required for Class D Oncology Devices

Accurate and complete documentation is crucial for a successful application. Key documents include:

  • Company Constitution: Incorporation certificate, partnership deed, or LLP documents.
  • Proof of Ownership or Lease of Premises: To establish legal rights over manufacturing site.
  • Technical Staff Qualifications: Details of qualified personnel responsible for manufacturing and quality.
  • Fire NOC and Pollution NOC: Compliance with local safety and environmental regulations.
  • Device Master File (DMF): Detailed technical specifications, design, manufacturing processes, and testing protocols. Our Device Master File guide can help streamline this.
  • Plant Master File (PMF): Description of manufacturing facilities, equipment, and quality control measures. Refer to our Plant Master File guide.
  • Essential Principles Checklist: Demonstrating conformity with applicable standards.
  • Risk Management File: Documenting risk analysis and mitigation strategies, aligned with ISO 14971. See our Risk Management guide for best practices.
  • Test Reports: From CDSCO-approved testing laboratories. Review the Testing Laboratories list for authorized options.
  • Labels and Instructions for Use (IFU): Must comply with regulatory requirements.
  • Quality Management System Documents: Including SOPs, CAPA, and internal audit records.

Import License Process for Alternating Electric Field Antimitotic Cancer Treatment System (MD15)

If you are importing this device into India, you must obtain an MD15 import license from the Central Licensing Authority. The process is as follows:

  1. Document Preparation: Gather required certificates such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
  2. Application Submission: File the application on Form MD14 through the CDSCO MD Online Portal.
  3. Query Resolution: Respond to any regulatory queries promptly.
  4. Grant of Import License (Form MD15): Issued once compliance is verified.

Typical timeline for import license approval is 5 to 6 months.

Import License Documents Required

Key documents for MD15 license include:

  • Valid Manufacturing License from the exporting country
  • Free Sale Certificate
  • ISO 13485:2016 Certification
  • CE Certificate or equivalent
  • Device Master File and Plant Master File
  • Wholesale License in India
  • Company Constitution

Costs vary based on device class and number of products.

Timeline and Processing Duration

License TypeProcess DurationKey Notes
MD13 Test License1.5 - 2 monthsMandatory before MD9 application
MD9 Manufacturing License4 - 5 monthsIncludes audit and query resolution
MD15 Import License5 - 6 monthsNo test license required

Planning for regulatory timelines upfront helps prevent costly delays.

Government Fees and Costs

For Class D devices like this oncology system, fees are as follows:

  • MD9 License: Rs 50,000 per application + Rs 1,000 per product
  • MD13 Test License: Separate fees apply (consult CDSCO portal for details)
  • MD15 Import License:
    • Rs 3,000 per site
    • Rs 1,500 per product

All applications and fee payments are made via the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance during audits.

Solution: Engage experienced consultants to conduct pre-submission gap analysis. Ensure all documents such as Device Master File and Risk Management Files are comprehensive and aligned with regulatory standards.

Challenge: Difficulty in coordinating product testing with government-approved labs.

Solution: Early engagement with labs listed on the CDSCO Testing Laboratories page to schedule tests and understand requirements.

Challenge: Responding to regulatory queries in a timely manner.

Solution: Maintain a dedicated regulatory affairs team or consultant to track application status and prepare prompt, thorough responses.

Expert Consultation and Support

Navigating the CDSCO licensing landscape for a Class D oncology device demands precision and experience. Our team has successfully supported over 500 medical device companies, offering:

  • Comprehensive gap assessments
  • End-to-end documentation preparation
  • Coordination with notified bodies and testing labs
  • Application submission and follow-up
  • Audit readiness and mock inspections

We recommend early engagement to align your manufacturing or import processes with CDSCO expectations, avoiding costly rejections or delays.

Getting Started with Your CDSCO License Application

To begin your CDSCO licensing journey for the Alternating Electric Field Antimitotic Cancer Treatment System:

  1. Register on the CDSCO MD Online Portal: Create an account to access all application forms and updates.
  2. Conduct a thorough documentation audit: Use our guides on Device Master File and Plant Master File to prepare your files.
  3. Apply for the MD13 Test License: Initiate this to enable product testing.
  4. Schedule product testing: Engage with government-approved labs early.
  5. Prepare for audits: Review requirements and ensure your QMS and premises comply.
  6. Submit MD9 application: Once testing is complete and documents are ready.
  7. Respond promptly to queries: Maintain open communication with CDSCO.

Taking these actionable steps with expert guidance will position your advanced oncology device for a successful market entry in India.

For personalized assistance, reach out to our regulatory consulting team to discuss your specific project requirements and timelines.

Get Expert Help

Free consultation for your medical device license

24/7 Support Available

Why Choose Us

500+ Licenses Obtained
100% Success Rate
15+ Years Experience
24/7 Support Available

About the Author

avatar
Tails Azimuth
@Twitter