CDSCO License for Artificial airway washing/disinfection jar

Comprehensive CDSCO Licensing Guide for Artificial Airway Washing/Disinfection Jar (Class B)

Introduction to Artificial Airway Washing/Disinfection Jar and Regulatory Importance

The Artificial Airway Washing/Disinfection Jar is a critical device in anesthesiology, designed to hold artificial airway devices during their washing and disinfection processes. Given its direct involvement in infection control and patient safety, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing this device in India.

As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies, we understand the complexities and nuances involved in obtaining CDSCO licenses for Class B medical devices like this jar. This guide offers detailed, actionable insights to streamline your license application, ensuring compliance and timely market access.

CDSCO Regulatory Framework for Artificial Airway Washing/Disinfection Jar

CDSCO categorizes medical devices based on risk, intended use, and complexity. The Artificial Airway Washing/Disinfection Jar falls under Class B (low-moderate risk) as per Notification 29/Misc/03/2020-DC(177) dated 12.07.2021. This classification requires manufacturers to obtain a Manufacturing License (MD5) from the State Licensing Authority.

Furthermore, the device is regulated under the anesthesiology category, requiring adherence to specific quality standards, safety protocols, and documentation requirements laid out by CDSCO.

Risk Classification and License Requirements

• Risk Class: B (Low-Moderate Risk)
• Applicable License: MD5 Manufacturing License
• Governing Authority: State Licensing Authority
• Applicable Forms:
  • Test License: Form MD13
  • Manufacturing License: Form MD3 (application), Form MD5 (grant)

Class B devices must undergo a test license phase and product testing by CDSCO-approved laboratories before full license approval.

Manufacturing License Process for Artificial Airway Washing/Disinfection Jar (MD5)

The pathway to obtaining an MD5 license involves several critical steps:

1. Test License Application (Form MD13): Obtain a test license to manufacture the device for testing purposes. This phase allows limited production solely for evaluation.
2. Product Testing: Conduct mandatory testing at government-approved laboratories to validate compliance with safety and performance standards. You can check the list of testing laboratories authorized by CDSCO.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Manufacturing License Application (Form MD3): Submit the application for the manufacturing license through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit conducted by a notified body ensures your manufacturing premises comply with regulatory standards. Refer to the list of notified bodies for authorized auditors.
6. Query Resolution: Address any queries or deficiencies highlighted by the licensing authority or audit team promptly.
7. Grant of License (Form MD5): Upon satisfactory review, the State Licensing Authority grants the manufacturing license.

Manufacturing License Documents Required

To ensure a smooth application, gather the following critical documents:

• Company Constitution (Incorporation Certificate, MOA, AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (technical specifications, design, manufacturing process) – see our detailed Device Master File guide
• Plant Master File (facility layout, utilities, quality control) – learn how to create one in our Plant Master File guide
• Essential Principles Checklist (compliance with Indian Medical Device Rules)
• Risk Management File (hazard identification, risk evaluation, mitigation) – refer to our Risk Management guidance
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, including SOPs and CAPA records

Import License Process for Artificial Airway Washing/Disinfection Jar (MD15)

If you plan to import this device, an MD15 Import License from the Central Licensing Authority is mandatory. The process differs slightly:

1. Document Preparation: Prepare import-specific documents such as Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and the Device and Plant Master Files.
2. Application Submission: Apply through the CDSCO MD Online Portal using Form MD14.
3. Queries and Review: The Central Licensing Authority reviews your application and raises queries if needed.
4. License Grant: Upon clearance, the license is granted on Form MD15.

Import License Documents Required

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

Timeline and Processing Duration

For import licenses (MD15), the total timeline extends to approximately 5 to 6 months due to additional scrutiny.

Government Fees and Costs

• MD5 License (Class B):

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD15 Import License:

  • Site Fee (Class B): Rs. 1,50,000 (~$2000)
  • Per Product Fee: Rs. 75,000 (~$1000)

Additional costs include testing fees, audit fees charged by notified bodies, and preparation of documentation.

Common Challenges and Solutions

Challenge: Delays in product testing due to backlogs at government labs.

Solution: Initiate testing early and consider accredited private labs with CDSCO recognition to expedite results.

Challenge: Incomplete or inconsistent documentation leading to repeated queries.

Solution: Engage with experienced consultants to ensure thorough document preparation, including robust risk management and QMS files.

Challenge: Non-compliance during notified body audit.

Solution: Conduct internal audits and mock inspections prior to official audit to identify and mitigate gaps.

Expert Consultation and Support

With decades of hands-on experience, we provide end-to-end support from initial classification to post-license compliance. Our expertise includes:

• Preparing comprehensive Device and Plant Master Files
• Coordinating with notified bodies and testing labs
• Managing queries and audit responses
• Training technical staff on regulatory requirements

Our clients benefit from reduced timelines and minimized risks of rejection.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device’s Class B status using the Medical Device Classification tool.
2. Register on CDSCO MD Online Portal: Create your company profile to initiate applications.
3. Prepare Test License Application (Form MD13): Start limited manufacturing for product testing.
4. Engage a Notified Body Early: Schedule audits and pre-assessment visits.
5. Compile Required Documents: Use our detailed guides on Device Master File and Plant Master File preparation.
6. Submit Manufacturing License Application (Form MD3): After successful testing and audit.
7. Respond Promptly to Queries: Maintain communication with CDSCO and the notified body.

Embarking on your CDSCO licensing journey with expert guidance ensures compliance, reduces time-to-market, and positions your Artificial Airway Washing/Disinfection Jar for success in the competitive Indian healthcare sector.