CDSCO License for Endoscopic electrosurgical biopsy/resection kit, full- thickness

Comprehensive Guide to CDSCO Licensing for Endoscopic Electrosurgical Biopsy/Resection Kit (Full-Thickness)

Navigating the regulatory landscape for medical devices in India demands precision, expertise, and up-to-date knowledge. As seasoned regulatory consultants with over 25 years of experience assisting more than 500 companies, we provide you with a detailed, step-by-step roadmap to secure your CDSCO license for the Endoscopic Electrosurgical Biopsy/Resection Kit (Full-Thickness), a Class C gastroenterology device.

About the Device and Its Regulatory Importance

The Endoscopic Electrosurgical Biopsy/Resection Kit is a collection of sterile devices, including an implantable haemostatic ligation clip. Its primary purpose is to facilitate full-thickness tissue biopsy and therapeutic resection of gastric, duodenal, colonic, and rectal tissues during endoscopic procedures. Given its invasive nature and implantable components, this device falls under Class C risk category, demanding stringent regulatory oversight to ensure patient safety and efficacy.

Obtaining CDSCO approval not only ensures compliance with Indian regulations but also builds trust among healthcare providers and patients by affirming the device's quality and safety standards.

CDSCO Regulatory Framework for Endoscopic Electrosurgical Biopsy/Resection Kit

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Devices are classified based on risk, and this classification determines the licensing pathway.

For Class C devices like the Endoscopic Electrosurgical Biopsy/Resection Kit, the licensing authority is the Central Licensing Authority of CDSCO. The relevant manufacturing license is known as the MD9 license, applied through Form MD7.

Risk Classification and License Requirements

• Device: Endoscopic Electrosurgical Biopsy/Resection Kit (Full-Thickness)
• Risk Class: C
• Category: Gastroenterology
• License Type: MD9 (Central License)

Class C devices pose moderate to high risk, often involving invasive procedures with implantable components, thus requiring rigorous evaluation, including product testing, audit, and document scrutiny.

For comprehensive understanding, you may refer to the Medical Device Classification guide.

Manufacturing License Process (MD9 License) for Class C Devices

The MD9 license process typically spans around 4 to 5 months. This timeline includes mandatory steps such as obtaining a test license, product testing, document preparation, application submission, audit, and query resolution.

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 manufacturing license, you must secure a test license via Form MD13. This license permits product testing in government-recognized labs. The test license process takes approximately 1.5 to 2 months.

Step 2: Product Testing

The Endoscopic Electrosurgical Biopsy/Resection Kit must undergo rigorous testing for safety and performance parameters, including biocompatibility, sterility, electrical safety, and mechanical integrity. Testing must be conducted at CDSCO approved laboratories. A current list of Testing Laboratories is available on the CDSCO portal.

Step 3: Document Preparation

Simultaneously, prepare comprehensive documentation including your Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, Quality Management System (QMS) documents, and others detailed below.

Step 4: Application Submission (Form MD7)

Submit your manufacturing license application through the CDSCO MD Online Portal using Form MD7 for MD9 licenses. Ensure all documents are complete and compliant to avoid delays.

Step 5: CDSCO Inspection and Audit

Once the application is accepted, CDSCO inspectors will conduct an on-site audit of your manufacturing facility and QMS to verify compliance with regulatory requirements.

Step 6: Query Resolution

Respond promptly to any queries or observations raised by the CDSCO inspectors or the department to ensure smooth processing.

Step 7: License Grant (Form MD9)

Upon successful audit and document verification, CDSCO will grant the manufacturing license on Form MD9.

For an in-depth explanation, you may consult our MD9 License Guide.

Manufacturing License Documents Required for MD9

Ensure the following documents are meticulously prepared and submitted:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications, designs, and manufacturing processes
• Plant Master File (PMF) describing manufacturing facilities and quality controls
• Essential Principles Checklist confirming compliance with regulatory standards
• Risk Management File showcasing hazard analysis and mitigation strategies
• Product Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Comprehensive guides for DMF and PMF preparation are available here: Device Master File Guide and Plant Master File Guide.

Import License Process (MD15) for Class C Devices

If you are an importer seeking to bring the Endoscopic Electrosurgical Biopsy/Resection Kit into India, the import license process is managed by the Central Licensing Authority under the MD15 license.

Key points include:

• No test license required before application.
• Application submission via Form MD14 on the CDSCO MD Online Portal.
• Mandatory document submission including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF, PMF, Wholesale License, and Company Constitution.
• The process takes approximately 5 to 6 months.

Government fees are tiered based on device class and number of products. For Class C & D devices, fees are USD 3000 per site and USD 1500 per product.

Detailed insights can be found in our Import License Guide.

Timeline and Processing Duration

Government Fees and Costs

Note: Costs are exclusive of consultancy, testing, and other indirect expenses.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved testing labs early to book slots and clarify testing protocols upfront.

Challenge 2: Incomplete or Non-compliant Documentation

• Solution: Use detailed checklists and expert reviews to ensure all files like DMF, PMF, and Risk Management are comprehensive and aligned with regulatory expectations.

Challenge 3: Audit Non-conformities

• Solution: Conduct internal audits and mock inspections prior to CDSCO visits to identify and mitigate gaps.

Challenge 4: Query Resolution Delays

• Solution: Prepare a dedicated regulatory liaison team to address CDSCO queries promptly and accurately.

Expert Consultation and Support

Our team has successfully facilitated over 500 CDSCO licensing projects across all device classes, including complex Class C devices like the Endoscopic Electrosurgical Biopsy/Resection Kit. We offer end-to-end support:

• Gap analysis and regulatory strategy
• Preparation of Device and Plant Master Files
• Coordination with testing laboratories
• Application filing and audit support
• Post-approval compliance management

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device’s risk class leveraging CDSCO’s classification rules.
2. Engage Early: Initiate contact with accredited testing labs and notified bodies.
3. Prepare Documentation: Compile your DMF, PMF, Risk Management, QMS, and other essential documents.
4. Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal.
5. Plan for Audit: Schedule internal audits and prepare for CDSCO inspections.
6. Leverage Expertise: Partner with experienced consultants to navigate complexities efficiently.

Embarking on your licensing journey with a clear, informed strategy reduces time to market and positions your Endoscopic Electrosurgical Biopsy/Resection Kit for successful adoption in the Indian healthcare ecosystem.

For personalized guidance, contact us to leverage our 25+ years of regulatory expertise and streamline your CDSCO licensing process.