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CDSCO License for Breathing circuit dryer

Medical Device Information

Important Notice for Class A Devices

Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).

Device Class
Class A

Intended Use

A device that is used for the purpose of drying breathing circuit equipment that have been washed inorder to  prevent bacteria growth and deterioration

Manufacturing License
MD5
Import License
MD15
CDSCO License for Breathing circuit dryer

Comprehensive Guide to CDSCO Licensing for Breathing Circuit Dryer (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in navigating the Indian medical device regulatory landscape, we understand the critical importance of obtaining the correct CDSCO license for your medical device. In this article, we delve into the specific requirements and processes for securing a manufacturing license (MD5) for a Breathing Circuit Dryer, a Class A device used in anesthesiology for drying breathing circuit equipment and preventing bacterial growth and equipment deterioration.

Understanding the Breathing Circuit Dryer and Regulatory Importance

A Breathing Circuit Dryer is an essential device in anesthesiology settings, designed to dry washed breathing circuits to maintain hygiene and prevent microbial contamination. Given its direct role in patient safety and infection control, regulatory oversight ensures these devices meet stringent quality and safety standards. In India, the Central Drugs Standard Control Organization (CDSCO) regulates such devices under the Medical Device Rules (MDR) 2017, and compliance is mandatory before manufacturing or marketing.

CDSCO Regulatory Framework for Breathing Circuit Dryer

This device falls under Risk Class A, the lowest risk category based on the Medical Device Classification by CDSCO. Class A devices are considered low risk but still require a manufacturing license from the State Licensing Authority under Form MD5.

The notification governing this device is 29/Misc/03/2020-DC(177) dated 12.07.2021, which aligns with the latest regulatory updates.

Risk Classification and License Requirements

Risk ClassLicense TypeLicensing AuthorityApplication FormProcessing TimeFees (Approx)
Class AMD5 LicenseState Licensing AuthorityMD33-4 monthsRs 5000 (application) + Rs 500 per product

For your Breathing Circuit Dryer, the MD5 manufacturing license is mandatory before commercial production.

Manufacturing License Process (MD5) for Breathing Circuit Dryer

The MD5 license process is a multi-step journey:

  1. Test License (Form MD13): Initially, you must obtain a test license from the State Licensing Authority. This license allows you to manufacture and test the device on a small scale for compliance validation. The test license process typically takes 1.5 to 2 months.

  2. Product Testing: Post test license, your device samples must be tested at CDSCO-approved government laboratories. Refer to the Testing Laboratories list for accredited labs. Testing can take 4-6 weeks depending on the device complexity.

  3. Documentation Preparation: Prepare your comprehensive dossier including technical, quality, and safety documentation.

  4. Submission of Application (Form MD3): Apply for the manufacturing license via the CDSCO MD Online Portal.

  5. Audit by Notified Body: An audit will be conducted by a notified body from the list of notified bodies. This audit ensures compliance with Good Manufacturing Practices (GMP) and QMS.

  6. Resolution of Queries: Address any observations or queries raised by the licensing authority or notified body.

  7. Grant of License: Upon successful review and audit clearance, the MD5 license is granted.

Manufacturing License Documents Required for MD5

To streamline your application, ensure you have the following documents meticulously prepared:

  • Company Constitution: Memorandum and Articles of Association or equivalent
  • Proof of Ownership of Premises: Sale deed, lease agreement, or rental agreement
  • Technical Staff Credentials: Qualification and experience certificates of key technical personnel
  • Fire NOC and Pollution Control NOC: Mandatory environmental compliances
  • Device Master File (DMF): Detailed device specifications, manufacturing process, and quality controls. Our Device Master File guide offers practical insights.
  • Plant Master File (PMF): Facility layout, equipment details, manufacturing workflow. Refer to our Plant Master File guide
  • Essential Principles Checklist: Declaration of conformity to Indian MDR Essential Principles
  • Risk Management File: Comprehensive risk analysis and mitigation strategies per Risk Management best practices
  • Test Reports: From CDSCO-approved labs validating device safety and efficacy
  • Labels and Instructions for Use (IFU): Compliant with MDR labeling requirements
  • Quality Management System (QMS) Documents: ISO 13485 certification and internal procedures

Import License Process (MD15) for Breathing Circuit Dryer

If you intend to import the Breathing Circuit Dryer into India, a separate MD15 import license is required from the Central Licensing Authority.

  • Application Form: MD14
  • Processing Time: 5-6 months
  • Fees: Varies by class, Class A approximately 1000persite+1000 per site + 50 per product

Key documents include manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.

For detailed guidance, visit our Import License guide.

Timeline and Processing Duration

StageDuration
Test License (MD13)1.5 to 2 months
Product Testing4 to 6 weeks
Document Preparation2 to 3 weeks
MD5 Application & Audit1.5 to 2 months
Query Resolution2 to 3 weeks
Total Approximate Time3 to 4 months

Government Fees and Costs

  • Application fee for MD5 license: Rs 5000
  • Per product fee: Rs 500
  • Test license fee (MD13): Generally nominal, varies by state
  • Testing charges: Depends on test parameters and lab
  • Audit charges: Payable to notified body as per their tariff

Budgeting accurately for these fees will avoid unexpected delays.

Common Challenges and Solutions

  • Incomplete Documentation: Many applicants falter due to gaps in technical dossiers. We recommend thorough cross-checking against the checklist.

  • Delays in Testing: Choosing CDSCO-approved labs with proven turnaround times can save weeks.

  • Audit Non-compliance: Pre-audit readiness and mock audits help identify and fix gaps early.

  • Query Management: Prompt and precise responses to CDSCO queries accelerate approvals.

  • Understanding Regulatory Updates: Staying current with notifications like 29/Misc/03/2020-DC(177) is critical. Subscribe to official updates.

Expert Consultation and Support

Our extensive expertise, gained from assisting over 500 clients, equips us to help you navigate these challenges seamlessly. We offer tailored regulatory strategy, dossier preparation, liaison with notified bodies, and audit support specifically for Class A devices like the Breathing Circuit Dryer.

Getting Started with Your CDSCO License Application

  1. Assess your device classification and confirm it as Class A.
  2. Gather all required documentation, leveraging our guides for DMF and PMF.
  3. Apply for the test license (MD13) via the CDSCO MD Online Portal.
  4. Coordinate product testing at CDSCO-approved labs.
  5. Prepare for notified body audit by conducting internal reviews.
  6. Submit your MD5 application (Form MD3) on the online portal.
  7. Engage with authorities promptly to resolve any queries.

Embarking on this journey with expert guidance ensures your Breathing Circuit Dryer enters the Indian market compliantly and efficiently. Contact us today to initiate your CDSCO licensing process and secure your manufacturing license with confidence.

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About the Author

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Tails Azimuth
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