CDSCO License for Gastrointestinal manometric catheter, non- electronic

Comprehensive Guide to CDSCO Licensing for Gastrointestinal Manometric Catheter (Non-Electronic)

As seasoned regulatory consultants with over 25 years of experience assisting more than 500 medical device companies, we understand the intricacies of navigating the CDSCO licensing landscape in India. This guide focuses on the Gastrointestinal manometric catheter, non-electronic, a Class B medical device used extensively in gastroenterology for assessing GI tract motility. Here, we provide detailed, actionable insights for manufacturers and importers aiming to secure CDSCO approval efficiently.

Understanding the Device and Its Regulatory Importance

The Gastrointestinal manometric catheter is a non-sterile, non-electrical flexible tube designed to be inserted via the nose or rectum to measure pressures within the GI tract, crucial for diagnosing conditions such as gastro-oesophageal reflux disease (GERD) and faecal incontinence. Despite its straightforward design, regulatory scrutiny is rigorous due to its direct patient contact and diagnostic purpose. Compliance ensures patient safety and market legitimacy in India.

CDSCO Regulatory Framework for Gastrointestinal Manometric Catheters

This device falls under the Gastroenterology category and is classified as a Class B medical device per CDSCO's risk classification. The regulatory framework mandates manufacturers to obtain an MD5 manufacturing license from the State Licensing Authority before commercial distribution.

The device is notified under notification number 29/Misc./03/2020-DC (182) dated 27.09.2021, confirming its inclusion under CDSCO’s purview.

Risk Classification and License Requirements

• Risk Class: B (Low to moderate risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Authority: State Licensing Authority
• Applicable Guidelines: Medical Device Rules 2017

For Class B devices, the process involves obtaining a test license (Form MD13) first, conducting product testing, followed by audit and final manufacturing license grant.

Manufacturing License Process (MD5) for Class B Devices

1. Test License Application (Form MD13): Initiate by applying for a test license, which allows sample testing in government-approved laboratories.
2. Product Testing: Submit device samples to CDSCO-recognized labs. Testing typically covers biocompatibility, mechanical integrity, and material safety.
3. Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit by a notified body listed on the Notified Bodies List is mandatory to verify manufacturing premises, QMS, and compliance.
6. Query Resolution: Address any queries raised by the State Licensing Authority or the notified body promptly.
7. License Grant (Form MD5): Upon successful compliance, the MD5 license is granted, allowing commercial manufacturing.

Manufacturing License Documents Required for Gastrointestinal Manometric Catheter

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Details of manufacturing facilities and equipment (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety standards
• Risk Management File complying with ISO 14971 (Risk Management Guide)
• Test Reports from government-approved laboratories (Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified

Import License Process (MD15) for the Gastrointestinal Manometric Catheter

For importers, an MD15 import license from the Central Licensing Authority is mandatory before marketing the device in India.

Process Overview:

• Compile necessary documents including valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and Company Constitution.
• Submit application using Form MD14 through the CDSCO MD Online Portal.
• Resolve any department queries.
• Await license grant (Form MD15).

Import License Documents Required

• Valid foreign manufacturing license
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license for distribution in India
• Company Constitution and incorporation documents

Timeline and Processing Duration

Typically, manufacturers should plan for a total of 3 to 4 months from test license application to MD5 license grant for Class B devices like the gastrointestinal manometric catheter.

Government Fees and Costs

• MD5 License Application Fee: Rs 5,000 per application
• Per Product Fee: Rs 500
• Test License Fee (MD13): Separate fees apply during test license application

Additional costs to consider:

• Laboratory testing fees
• Notified body audit charges
• Consultancy and documentation preparation

For import licenses (MD15), fees vary by device class, with Class B devices generally incurring around $2,000 per site and$1,000 per product.

Common Challenges and Solutions

• Delays in Sample Testing: Testing labs can have backlogs. Plan sample submission early and use labs from the approved Testing Laboratories list.
• Incomplete Documentation: Ensure all master files and risk management documents are comprehensive and updated.
• Audit Non-Compliance: Prepare thoroughly for audits by reviewing past audit reports and conducting internal audits.
• Query Resolution Delays: Respond promptly to regulatory queries with complete information.

Expert Consultation and Support

Navigating CDSCO regulatory processes can be complex. Our expert team has successfully guided over 500 manufacturers through these exact processes. We offer tailored support including:

• Preparing Device and Plant Master Files
• Conducting gap analysis for QMS compliance
• Coordinating with notified bodies and testing labs
• Managing application submissions and follow-ups

Our deep understanding of CDSCO nuances ensures smoother approvals and quicker market entry.

Getting Started with Your CDSCO License Application

1. Evaluate your device classification: Confirm the Class B status via the Medical Device Classification tool.
2. Prepare necessary documentation: Begin compiling your Device Master File and Plant Master File following the linked guides.
3. Apply for Test License (Form MD13): Submit your initial application through the CDSCO MD Online Portal.
4. Schedule product testing: Coordinate with government-approved laboratories early.
5. Plan for audit: Select a notified body from the Notified Bodies List and prepare your facility accordingly.
6. Submit Manufacturing License (Form MD3): After successful testing and audit readiness, apply via the CDSCO portal.
7. Engage expert consultants: Consider partnering with experienced regulatory consultants to streamline the process and avoid common pitfalls.

By following these step-by-step actions, manufacturers and importers of the gastrointestinal manometric catheter can confidently navigate the regulatory pathway in India, ensuring compliance and timely market access.

For personalized assistance, do not hesitate to reach out to our regulatory consulting team with over 25 years of proven expertise in CDSCO licensing and medical device compliance.