CDSCO License for Electro cancer therapy system
Medical Device Information
Intended Use
An assembly of devices designed for the treatment of tumours and the destruction of their cancerous cells using low-voltage direct current of small intensity delivered via electrodes placed across the affected body area.
Comprehensive Guide to Obtaining CDSCO MD9 License for Electro Cancer Therapy Systems
Electro Cancer Therapy Systems represent a cutting-edge advancement in oncology treatment, harnessing low-voltage direct current to selectively target and destroy cancerous cells. Given their critical role in patient care, these devices fall under Class C risk classification according to CDSCO regulations, necessitating stringent regulatory oversight to ensure safety and efficacy.
As regulatory consultants with over 25 years of experience and having assisted more than 500 companies in navigating India's medical device approval landscape, we understand the unique challenges and requirements involved in obtaining a CDSCO manufacturing license for such complex devices.
CDSCO Regulatory Framework for Electro Cancer Therapy Systems
The Central Drugs Standard Control Organisation (CDSCO) governs the approval and licensing of medical devices in India under the Medical Device Rules 2017. Electro Cancer Therapy Systems are categorized under oncology devices and notified under File No. 29/Misc./03/2020-DC (153) — Part 1 dated 11.10.2022.
Being a Class C device, the regulatory pathway involves obtaining an MD9 license from the Central Licensing Authority. This classification reflects the moderate to high risk associated with the device, requiring comprehensive testing, documentation, and audits.
Risk Classification and License Requirements
- Device Name: Electro Cancer Therapy System
- Risk Class: C (Moderate to High Risk)
- License Type: MD9 Manufacturing License (Form MD7)
- Regulatory Authority: CDSCO Central Licensing Authority
Class C devices such as this require a more rigorous approval process than Class A or B devices, involving detailed product testing, quality management systems, and mandatory audits by CDSCO inspectors.
Manufacturing License Process (MD9)
The MD9 license process spans approximately 4 to 5 months and includes several critical stages:
Test License Acquisition (Form MD13): Before applying for the manufacturing license, you must secure a test license which takes approximately 1.5 to 2 months. This enables you to conduct product testing as per Indian standards.
Product Testing: Testing must be performed at CDSCO-approved government laboratories. You can find the list of approved testing laboratories to select from.
Document Preparation: Compilation of comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and other technical and quality documents.
License Application (Form MD7): Submit your application through the CDSCO MD Online Portal with all required documents.
Audit by CDSCO Inspectors: An on-site audit evaluates compliance with QMS and regulatory requirements.
Queries Resolution: Address any queries or observations raised by the CDSCO or auditors promptly.
Grant of MD9 License: Upon satisfactory compliance, the license is issued on Form MD9.
Manufacturing License Documents Required
For a Class C Electro Cancer Therapy System, ensure you prepare the following documentation meticulously:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed product specifications, design, manufacturing process. Refer to our comprehensive Device Master File guide.
- Plant Master File (PMF): Details of manufacturing facility, equipment, and quality controls. Learn how to create your PMF efficiently here.
- Essential Principles Checklist verifying compliance with Indian medical device regulations.
- Risk Management File: Documenting risk analysis and mitigation strategies compliant with ISO 14971. See our Risk Management insights.
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs
Import License Process (MD15)
If you plan to import Electro Cancer Therapy Systems into India, an MD15 import license from CDSCO's Central Licensing Authority is mandatory. The process generally takes 5 to 6 months and includes:
- Preparation of documents such as Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale License
- Submission of application via the CDSCO MD Online Portal
- Resolution of any departmental queries
- Grant of import license (Form MD15)
Government fees vary by product class; for Class C devices, expect approximately 1500 per product.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| MD9 License Application Review | 1 - 2 months |
| Audit and Queries Resolution | 3 - 4 weeks |
| Total Duration | 4 - 5 months |
Government Fees and Costs
- MD9 Application Fee: Rs 50,000 per application
- Per Product Fee: Rs 1,000
- Testing Fees: Variable depending on laboratory and number of tests
- Audit Fees: Included in CDSCO charges
Budgeting accurately for these costs upfront helps avoid delays and financial surprises.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or inadequate risk management data.
Solution: Engage regulatory experts early to prepare and review your Device and Plant Master Files. Utilize specialized templates and checklists to ensure compliance.
Challenge: Extended timelines caused by product testing failures or audit non-conformities.
Solution: Conduct internal pre-testing and mock audits. Select reputable CDSCO-approved testing labs and prepare your manufacturing facility per ISO 13485 standards.
Challenge: Confusion regarding regulatory updates and classification nuances.
Solution: Regularly consult the official CDSCO notifications and leverage professional consultation services to stay current.
Expert Consultation and Support
Our team has facilitated over 500 successful CDSCO license applications, including complex Class C oncology devices like Electro Cancer Therapy Systems. We provide end-to-end support from test license acquisition, documentation preparation, liaison with notified bodies, to final license grant.
Our approach is practical, proactive, and tailored to your specific device and organizational needs, ensuring faster approvals with minimal hassles.
Getting Started with Your CDSCO License Application
- Assess Device Classification and Regulatory Pathway: Confirm your device is Class C and requires an MD9 license.
- Initiate Test License Application: Apply for Form MD13 via the CDSCO MD Online Portal. Prepare for 1.5-2 months processing.
- Identify CDSCO-Approved Testing Laboratories: Choose labs from the official list and plan your testing schedule.
- Compile Required Documentation: Start assembling your Device Master File, Plant Master File, risk management documentation, and QMS files.
- Plan Your Audit Preparation: Ensure your manufacturing premises and processes comply with CDSCO and ISO 13485 standards.
- Submit Application and Monitor Progress: Track your application status online and respond promptly to any CDSCO queries.
Embarking on the CDSCO MD9 licensing journey for your Electro Cancer Therapy System is complex but manageable with the right expertise and preparation. Connect with us to leverage our deep regulatory knowledge and streamline your path to market entry in India’s growing medical device sector.
