CDSCO License for Electroporation therapy system

Electroporation Therapy System: Regulatory Overview and Importance

Electroporation therapy systems are advanced medical devices used in oncology to facilitate the delivery of therapeutic agents like drugs and genetic material directly into cells by applying controlled electrical impulses. This innovative technology, encompassing electrochemotherapy (ECT) and electrogenetherapy (EGT), demands stringent regulatory compliance to ensure patient safety and device efficacy. Given its critical role and complex mechanism, obtaining the correct approval from the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing this device in India.

With over 25 years of expertise and having supported more than 500 companies in navigating CDSCO licensing, we understand the nuances involved in registering Class C medical devices like the Electroporation Therapy System. Our insights will help you streamline your application process, avoid common pitfalls, and achieve timely market entry.

CDSCO Regulatory Framework for Electroporation Therapy Systems

The regulatory framework governing electroporation therapy systems falls under the Medical Devices Rules (MDR) 2017, administered by CDSCO under the Ministry of Health and Family Welfare. Since your device is classified as Class C due to its invasive nature and potential risk, it requires a manufacturing license from the Central Licensing Authority.

The relevant license type for manufacturing is the MD9 license, as per Form MD7, which covers Class C and D devices regulated centrally. If you are importing this device, an MD15 import license is also required.

The notification for this device category is documented under File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022, confirming its categorization and regulatory oversight.

Risk Classification and License Requirements for Electroporation Therapy System

Device Risk Class: Class C
Regulatory Authority: Central Licensing Authority, CDSCO
License Type: MD9 Manufacturing License (Form MD7)
Import License: MD15 (Form MD14)

Class C devices are considered moderate to high risk, requiring rigorous evaluation including product testing, document scrutiny, and facility audits.

For a detailed understanding of risk classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD9) for Class C Devices

The manufacturing license process for electroporation therapy systems involves the following key steps:

Test License (Form MD13): Before applying for the manufacturing license, obtain a test license valid for 1.5 to 2 months. This permits initial product testing.
Product Testing: Submit samples to CDSCO-approved testing laboratories for safety and performance evaluation. You can find the list of approved laboratories here.
Document Preparation: Compile the necessary documentation, including Device Master File (DMF), Plant Master File (PMF), risk management files, and QMS documents.
Application Submission: File the MD9 license application using Form MD7 through the CDSCO MD Online Portal.
CDSCO Inspection: CDSCO officials will conduct an on-site audit of your manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).
Query Resolution: Address any queries raised by CDSCO during the review process promptly.
License Grant: Upon satisfactory evaluation, the MD9 license is granted in Form MD9.

For comprehensive guidance on the MD9 license process, visit our MD9 License Guide.

Manufacturing License Documents Required for Electroporation Therapy Systems

The documentation requirements are extensive and must be meticulously prepared to avoid delays:

Company Constitution: Certificate of Incorporation, Memorandum and Articles of Association
Proof of Ownership or Lease of Premises: Property documents or valid lease deeds
Technical Staff Details: Qualification and experience certificates of the technical personnel
Fire NOC and Pollution Control NOC: Compliance certificates from local authorities
Device Master File (DMF): Detailed device description, design, manufacturing process, and performance data. Our Device Master File guide can help you prepare this critical document.
Plant Master File (PMF): Information about manufacturing facilities, equipment, and quality control systems. Refer to our Plant Master File guide for assistance.
Essential Principles Checklist: Compliance checklist confirming adherence to Indian Medical Device Rules.
Risk Management File: In line with ISO 14971 standards, documenting hazard analysis, risk evaluation, and mitigation strategies. You can review our Risk Management guide for best practices.
Test Reports: Certificates from CDSCO-approved labs validating product safety and performance
Labels and Instructions for Use (IFU): Drafts of product labels, packaging, and user manuals
Quality Management System (QMS) Documents: ISO 13485:2016 certification and supporting procedures

Import License Process (MD15) for Electroporation Therapy Systems

If you plan to import the electroporation therapy system into India, the MD15 license application process includes:

Document Compilation: Gather all prerequisite documents including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, and ISO 13485:2016.
Application Submission: Submit Form MD14 through the CDSCO MD Online Portal.
Review and Queries: CDSCO reviews application and may request clarifications.
License Grant: Upon compliance, MD15 license is issued.

Refer to our detailed Import License Guide for step-by-step support.

Import License Documents Required

Manufacturing license from the country of origin
Free Sale Certificate issued by the regulatory authority of the exporting country
ISO 13485:2016 certification
CE Certificate or equivalent international certification
Device Master File and Plant Master File
Wholesale license for distribution in India
Company Constitution and address proof
Technical documentation supporting safety and efficacy

Timeline and Processing Duration for Electroporation Therapy System Licensing

Process Stage	Duration (Approx.)
Test License (MD13)	1.5 to 2 months
Product Testing	1 to 1.5 months
Document Preparation	Concurrent with testing
Application Review & Audit	1.5 to 2 months
License Grant (MD9)	Total 4 to 5 months

For imports, the MD15 license typically takes 5 to 6 months due to additional scrutiny.

Government Fees and Costs

MD9 Manufacturing License Fees:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
Test License (MD13): Nominal fees as per CDSCO norms
Import License (MD15) Fees:
- For Class C devices: ₹3,000 per site + ₹1,500 per product

These fees must be paid online via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

1. Delays in Testing and Documentation

Testing laboratories often have backlogs. To avoid delays, engage with labs early and ensure all samples meet submission requirements. Our practical tip: parallelize document preparation with testing to save time.

2. Incomplete or Inaccurate Documentation

Errors in DMF or PMF documents can result in queries. Use professional templates and consult experts to ensure completeness and compliance.

3. Audit Non-Compliance

Manufacturers sometimes overlook GMP details. Conduct mock audits and internal training sessions to prepare your team.

4. Query Resolution Delays

Promptly respond to CDSCO queries with clear, evidence-backed answers. Delays often occur due to inadequate responses.

5. Complex Import Documentation

Ensure all foreign certificates are authenticated and translated if needed before submission.

Expert Consultation and Support

Navigating the CDSCO licensing process for Class C devices like electroporation therapy systems demands specialized expertise. We provide end-to-end consultancy, including:

Gap analysis and readiness assessment
Preparation and review of Device and Plant Master Files
Coordination with testing laboratories and notified bodies
Application filing and follow-up through the CDSCO MD Online Portal
Audit preparation and support

Our tailored approach has accelerated market approvals for hundreds of clients, minimizing regulatory risks and costs.

Getting Started with Your CDSCO License Application

To initiate your journey toward CDSCO approval for your Electroporation Therapy System:

Assess Your Device Classification: Confirm your device as Class C to determine the MD9 application route.
Prepare Documentation: Begin compiling the DMF, PMF, and risk management files immediately.
Apply for Test License (MD13): Submit your application for the test license to start product testing.
Engage with Approved Testing Laboratories: Schedule testing proactively to avoid bottlenecks.
Submit Manufacturing License Application (MD9): Once testing completes, file your MD9 application on the CDSCO MD Online Portal.
Plan for Audit: Coordinate with CDSCO for the inspection visit and ensure GMP compliance.

For detailed assistance and to avoid costly errors, reach out to our regulatory experts today. Leveraging our 25+ years of experience can be the difference between a smooth approval process and prolonged delays.

By following these guidelines and leveraging expert support, manufacturers and importers of Electroporation Therapy Systems can confidently navigate the CDSCO licensing landscape and successfully launch their innovative oncology devices in India.