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CDSCO License for Airway device cleaning  utensil

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 hand-held device intended to be used to clean an in situ  and ex situ airway device.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Airway device cleaning  utensil

Comprehensive Guide to CDSCO Licensing for Airway Device Cleaning Utensils (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies in obtaining CDSCO licenses, we understand the nuances involved in bringing Class A medical devices like airway device cleaning utensils to the Indian market. These hand-held devices, designed for cleaning both in situ and ex situ airway devices, fall under the anesthesiology category and require strict adherence to CDSCO regulations to ensure safety and efficacy.

Understanding the CDSCO Regulatory Framework for Airway Device Cleaning Utensils

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Since airway device cleaning utensils are classified as Class A (low risk) devices under the notification 29/Misc/03/2020-DC(177) dated 12.07.2021, they fall under the purview of the State Licensing Authority.

Class A devices must comply with the Medical Device Rules, 2017, which emphasize quality management systems, device master files, risk management, and product testing. Regulatory compliance ensures patient safety, market access, and credibility.

Risk Classification and License Requirements for Airway Device Cleaning Utensils

Class A medical devices are considered low risk but still require formal licensing. The license you need is the MD5 Manufacturing License, submitted via Application Form MD3 to the State Licensing Authority.

Key points:

  • Risk Class: A (Low Risk)
  • License Type: MD5 Manufacturing License
  • Application Form: MD3
  • Approving Authority: State Licensing Authority
  • Total Processing Time: 3-4 months (including test license and audit)

Manufacturing License Process (MD5) for Airway Device Cleaning Utensils

Obtaining an MD5 license is a multi-step process:

  1. Apply for Test License (Form MD13): Before the manufacturing license, you must obtain a test license, which allows product testing in government-approved laboratories. This typically takes 1.5 to 2 months.

  2. Product Testing: Conduct mandatory performance and safety tests at CDSCO-approved testing laboratories. Testing is crucial to demonstrate compliance with applicable standards.

  3. Prepare Documentation: Compile a comprehensive dossier including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, risk management files, and other regulatory documents.

  4. Submit Manufacturing License Application (Form MD3): Use the CDSCO MD Online Portal for electronic submission.

  5. Audit by Notified Body: An audit of your manufacturing facility is conducted by a CDSCO-recognized notified body. You can check the list of notified bodies approved for MD5 audits.

  6. Resolve Queries: Address any observations or deficiencies raised by the licensing authority or notified body.

  7. Grant of License (Form MD5): Upon satisfactory review, the State Licensing Authority issues the manufacturing license.

Essential Documents Required for MD5 License Application

For airway device cleaning utensils, ensure submission of the following:

  • Company Constitution: Memorandum and Articles of Association or Partnership Deed
  • Proof of Premises Ownership or Lease Agreement: Valid ownership documents
  • Technical Staff Details: Qualifications and experience certificates of technical personnel
  • Fire NOC & Pollution Control NOC: Compliance certificates from respective authorities
  • Device Master File (DMF): Detailed product design, specifications, manufacturing processes (refer our Device Master File guide)
  • Plant Master File (PMF): Facility and equipment details (Plant Master File guide)
  • Risk Management File: Hazard analysis and risk mitigation strategies (Risk Management)
  • Essential Principles Checklist: Compliance with Indian Medical Device rules
  • Test Reports: From CDSCO-approved labs (Testing Laboratories)
  • Labels and Instructions for Use (IFU): Accurate product labeling and user manuals
  • Quality Management System (QMS) Documents: Evidence of ISO 13485 or equivalent

Import License Process (MD15) for Airway Device Cleaning Utensils

If you plan to import airway device cleaning utensils, you need an MD15 Import License granted by the Central Licensing Authority.

Key steps include:

  1. Compile Import Documents: Manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, DMF, PMF, wholesale license, and company constitution.

  2. Apply on CDSCO MD Online Portal: Submit application through the portal.

  3. Query Resolution: Address any clarifications sought by the CDSCO.

  4. Grant of License: License is issued on Form MD15.

Note: No test license required; processing takes approximately 5-6 months.

Timeline and Processing Duration

Process StepDuration
Test License (MD13)1.5 – 2 months
Product Testing2 – 3 weeks
Document Preparation2 – 3 weeks
License ApplicationImmediate online
Audit and Inspection1 – 1.5 months
Query Resolution2 – 3 weeks
Total Time3 – 4 months

Government Fees and Costs for MD5 License

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

Additional costs include fees for testing at government labs and audit fees payable to notified bodies. Budget approximately Rs 50,000 to Rs 1,00,000 depending on the scope of testing and audit requirements.

Common Challenges and Practical Solutions

  • Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. We recommend a thorough pre-submission audit.

  • Delays in Test Reports: Leverage government-approved labs with faster turnaround times. Plan testing early.

  • Notified Body Audit Scheduling: Book audits well in advance as slots can fill quickly.

  • Query Management: Maintain prompt communication with CDSCO to avoid processing delays.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Drawing on our experience assisting 500+ firms, we provide tailored support including document preparation, audit readiness, and liaison with authorities. Our deep understanding of CDSCO processes ensures smoother, faster approvals.

Getting Started with Your CDSCO License Application for Airway Device Cleaning Utensils

  1. Assess Your Device Classification: Confirm Class A status per Medical Device Classification.

  2. Register on the CDSCO MD Online Portal: Start your application journey here.

  3. Plan Testing and Documentation: Initiate product testing and prepare your DMF, PMF, and risk files.

  4. Engage a Notified Body Early: Identify and contact notified bodies from the CDSCO notified bodies list.

  5. Submit Test License Application: Apply for Form MD13 to begin the process.

  6. Prepare for Audit: Ensure your manufacturing site is compliant with CDSCO requirements.

By following these steps and leveraging expert insights, you can efficiently obtain your MD5 license and enter the Indian medical device market with confidence.

For personalized assistance and detailed regulatory strategies, feel free to reach out to our consultancy team specialized in medical device compliance.

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About the Author

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Tails Azimuth
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