CDSCO License for Electroporation therapy system endoscopic applicator

Comprehensive Guide to CDSCO Licensing for Electroporation Therapy System Endoscopic Applicators (Class C Medical Device)

As a regulatory consultancy with over 25 years of experience and having successfully assisted 500+ companies obtain CDSCO licenses, we understand the complexities involved in bringing innovative medical devices like the Electroporation Therapy System Endoscopic Applicator to the Indian market. This Class C oncology device, designed to deliver targeted electrical impulses during endoscopy for electrochemotherapy, requires meticulous adherence to CDSCO regulations to ensure patient safety and compliance.

Understanding the CDSCO Regulatory Framework for Electroporation Therapy System Endoscopic Applicators

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. As per the medical device classification, your Electroporation Therapy System Endoscopic Applicator is designated as a Class C device due to its invasive nature and critical role in oncology treatment.

This classification mandates obtaining an MD9 manufacturing license granted by the Central Licensing Authority. This license ensures your device meets India's stringent quality, safety, and efficacy standards.

Risk Classification and Licensing Requirements

• Device Name: Electroporation Therapy System Endoscopic Applicator
• Risk Class: C (High risk, invasive therapeutic device)
• Intended Use: Sterile, patient-contact accessory for delivering electrical impulses during endoscopic electrochemotherapy
• Regulatory Notification: File No. 29/Misc./03/2020-DC (153) — Part 1; dated 11.10.2022

For Class C devices, the CDSCO stipulates the MD9 license, which is centrally issued and involves a comprehensive review process including test licensing, product testing, documentation audits, and inspections.

Detailed Manufacturing License Process (MD9) for Class C Devices

1. Test License Application (Form MD13):

   • Mandatory initial step allowing sample testing.
   • Processing time: Approximately 1.5-2 months.
   • Submit through the CDSCO MD Online Portal.

2. Product Testing:

   • Conducted at CDSCO-approved government laboratories listed here.
   • Testing includes biocompatibility, sterility, electrical safety, and performance validation relevant to electroporation devices.

3. Documentation Preparation:

   • Assemble comprehensive technical files including Device Master File and Plant Master File.
   • Refer to our detailed guides on Device Master Files and Plant Master Files.

4. License Application (Form MD7):

   • Submit complete application with all documents via the CDSCO portal.
   • Includes submission of Quality Management System (QMS) evidence, Essential Principles Checklist, Risk Management File, and Clinical Evaluation or Literature to support safety.

5. Audit & Inspection:

   • CDSCO inspectors perform an on-site audit.
   • The audit covers manufacturing processes, QMS compliance (ISO 13485:2016 preferred), and documentation.
   • Queries raised during this stage must be addressed promptly.

6. License Grant (Form MD9):

   • Upon satisfactory compliance, the MD9 manufacturing license is issued.
   • Validates your facility and product for manufacture and sale in India.

Essential Documents Required for MD9 License Application

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Premises Ownership or Lease Agreement
• Details and Qualification Certificates of Technical Personnel
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (Design, Manufacturing Processes, Specifications)
• Plant Master File (Facility Layout, Equipment, Environmental Controls)
• Essential Principles Checklist Compliance Document
• Risk Management File aligned with ISO 14971 (Risk Management Guidance)
• Test Reports from CDSCO-approved labs
• Product Labeling and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Electroporation Therapy System Endoscopic Applicators

For manufacturers or distributors importing this device into India, an MD15 import license issued by the Central Licensing Authority is mandatory.

• Application Form: MD14

• Documents Required:

  • Valid Manufacturing License (MD9) from the country of origin
  • Free Sale Certificate
  • CE Certificate (if applicable)
  • ISO 13485:2016 Certification
  • Device and Plant Master Files
  • Wholesale License
  • Company Constitution

• Fees:

  • For Class C & D devices, fees are approximately $3,000 per site and$1,500 per product.

• Timeline:

  • Processing typically takes 5-6 months.

Submit your application via the CDSCO MD Online Portal.

Timeline and Processing Duration Overview

Government Fees and Associated Costs

• MD9 Manufacturing License:
  • Application Fee: Rs. 50,000 (~USD 600)
  • Per Product Fee: Rs. 1,000 (~USD 12) per product
• Test License (MD13): Usually included in overall costs but confirm for specific cases
• Third-Party Testing: Varies by laboratory and test scope; budget for approximately Rs. 1-3 lakhs (~USD 1,200 - 3,600) depending on complexity
• Audit Fees: Generally borne by the manufacturer; notified bodies list is available here

Common Challenges and Practical Solutions

Challenge: Delays in document preparation and incomplete submissions.

• Solution: Start early by leveraging standardized templates for Device and Plant Master Files. Engage experts to ensure completeness and compliance.

Challenge: Prolonged product testing due to lack of clarity on test protocols.

• Solution: Consult with CDSCO-approved testing labs ahead of submission to understand test requirements specific to electroporation devices.

Challenge: Audit non-compliance findings.

• Solution: Conduct internal mock audits and maintain a robust QMS aligned with ISO 13485:2016.

Challenge: Communication gaps leading to delayed query responses.

• Solution: Assign a dedicated regulatory liaison to handle CDSCO communications promptly.

Expert Consultation and Support

Our team specializes in guiding manufacturers of Class C medical devices through every phase of CDSCO licensing—from initial classification to final audit clearance. We provide tailored assistance including gap analysis, document preparation, liaison with notified bodies, and post-submission follow-ups.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the risk class and licensing pathway for your Electroporation Therapy System Endoscopic Applicator.
2. Gather Preliminary Documents: Begin compiling corporate, manufacturing, and quality documents.
3. Apply for Test License (MD13): Submit your initial application on the CDSCO MD Online Portal to commence product testing.
4. Plan for Product Testing: Coordinate with CDSCO-approved labs to schedule necessary tests.
5. Prepare Technical Files: Utilize our Device Master File guide and Plant Master File guide for compliant documentation.
6. Engage a Regulatory Expert: Consider partnering with experienced consultants to streamline audits and query resolutions.

Navigating the CDSCO regulatory landscape efficiently can significantly shorten your time to market and ensure uninterrupted compliance. We invite you to leverage our expertise and resources to secure your MD9 manufacturing license for this critical oncology device.

For personalized support and to initiate your application, contact our regulatory team today.