CDSCO License for Breathing circuit washer/disinfector

Comprehensive Guide to CDSCO Licensing for Breathing Circuit Washer/Disinfector (Class B Device)

As seasoned regulatory consultants with over 25 years of experience and having guided 500+ companies through the CDSCO licensing process, we understand the critical importance of compliance for medical devices like the Breathing Circuit Washer/Disinfector. This device, classed as Risk Class B, plays a vital role in ensuring the cleanliness and high-level disinfection of breathing circuit components used in respiratory therapy and anesthesia equipment. Proper licensing not only ensures legal marketing in India but also assures safety and efficacy standards are met.

CDSCO Regulatory Framework for Breathing Circuit Washer/Disinfector

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Devices are classified into four risk categories — A, B, C, and D — with Class B representing low moderate risk devices. The Breathing Circuit Washer/Disinfector falls under the anesthesiology category and is notified under Notification 29/Misc/03/2020-DC(177) dated 12.07.2021.

Compliance with CDSCO regulations is mandatory for manufacturing or importing this device in India. The regulatory pathway for this Class B device requires obtaining an MD5 manufacturing license or an MD15 import license.

Risk Classification and License Requirements

As a Class B device, the Breathing Circuit Washer/Disinfector mandates an MD5 license for manufacturing within India, issued by the State Licensing Authority. For importers, an MD15 import license granted by the Central Licensing Authority is required.

• Manufacturing License (MD5) – Form MD3 application
• Import License (MD15) – Form MD14 application

Manufacturing License Process (MD5) for Breathing Circuit Washer/Disinfector

The MD5 licensing process involves multiple steps that typically span 3 to 4 months. The stages include:

1. Obtaining Test License (Form MD13) – Required before manufacturing; issued by the State Authority within 1.5 to 2 months.
2. Product Testing – Conducted at government-approved laboratories to verify safety and efficacy.
3. Document Preparation – Assemble comprehensive documentation including Device Master File and Plant Master File.
4. License Application Submission – Form MD3 submitted online via the CDSCO MD Online Portal.
5. Audit by Notified Body – An on-site audit for compliance verification. Check the list of notified bodies for audit requirements.
6. Queries and Clarifications – Address any observations raised by the CDSCO or notified body.
7. Grant of License (Form MD5) – Upon successful compliance, the license is granted.

Manufacturing License Documents Required

The documentation package for the Breathing Circuit Washer/Disinfector includes:

• Company Constitution and Registration Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire Department No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File detailing device specifications, design, and intended use (Refer to our detailed Device Master File guide)
• Plant Master File describing manufacturing facilities and quality systems (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with regulatory requirements
• Risk Management File outlining hazard analysis and mitigation measures (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485 compliant

Import License Process (MD15) for Breathing Circuit Washer/Disinfector

For importers, the MD15 license process is managed by CDSCO’s Central Licensing Authority and generally takes 5 to 6 months. The key steps are:

1. Document Preparation – Assemble all required documents including manufacturing license and product certifications.
2. License Application Submission – Form MD14 filed electronically via the CDSCO MD Online Portal.
3. Queries Resolution – Address any deficiencies pointed out by CDSCO.
4. License Grant (Form MD15) – License is issued upon satisfactory review.

Import License Documents Required

Key documents for import application include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate confirming product marketing in the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent conformity assessment
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Registration Documents

Timeline and Processing Duration

Government Fees and Costs

For the MD5 manufacturing license of a Class B device such as the Breathing Circuit Washer/Disinfector:

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

For MD15 import license (Class B):

• Site Fee: $2,000 USD per site
• Product Fee: $1,000 USD per product

Additional costs include fees for product testing in government labs and audit charges by notified bodies.

Common Challenges and Solutions

• Delayed Test License Grant: Early preparation and prompt submission reduce waiting time. Engage with notified bodies to schedule audits efficiently.
• Incomplete Documentation: Use our comprehensive checklists and guides to ensure all files such as Device Master File and Risk Management File are robust and complete.
• Audit Nonconformities: Conduct internal pre-audits and training to address compliance gaps before official audits.
• Product Testing Failures: Select government-approved labs with expertise in anesthesiology devices to ensure accurate testing.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like breathing circuit washers. With our extensive experience assisting over 500 companies, we provide tailored support including:

• Preparation of technical documentation
• Coordination with notified bodies and testing labs
• End-to-end application management on the CDSCO portal
• Post-license compliance and renewal advisories

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification – Confirm the device is Class B under the Medical Device Rules; refer to our Medical Device Classification resource.
2. Prepare Test License Application (Form MD13) – Initiate early to avoid bottlenecks.
3. Compile Documentation – Use our Device and Plant Master File guides to prepare strong dossiers.
4. Register on CDSCO MD Online Portal – Submit applications online at the CDSCO MD Online Portal.
5. Engage with Notified Body for Audit – Select an appropriate notified body from the official list.
6. Plan for Product Testing – Arrange testing at CDSCO-approved laboratories.

By following these actionable steps and leveraging expert guidance, manufacturers and importers can secure their CDSCO licenses efficiently, enabling timely market access for this critical anesthesiology device.

For personalized assistance, reach out to our regulatory experts who specialize in Class B medical devices to ensure your application process is smooth and compliant.