CDSCO License for Low energy ultrasound wound cleaner

Introduction to Low Energy Ultrasound Wound Cleaner and Regulatory Importance

A Low Energy Ultrasound Wound Cleaner is an innovative medical device designed to assist in wound management by using ultrasound energy to vaporize a solution, creating a mist for effective wound cleaning and maintenance debridement. Classified under dermatological and plastic surgery devices, this technology enhances wound care by promoting a cleaner environment conducive to healing.

Given its specialized use in clinical settings, regulatory compliance through the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to market this device in India. Ensuring adherence to CDSCO’s regulatory framework not only guarantees patient safety but also streamlines market entry and long-term business success.

CDSCO Regulatory Framework for Low Energy Ultrasound Wound Cleaner

The CDSCO regulates medical devices based on risk classification and intended use. As per the notification 29/Misc./03/2020-DC (147) dated 26.7.2021, the Low Energy Ultrasound Wound Cleaner falls under Class B (low moderate risk) within the dermatological and plastic surgery device category.

Being a Class B device, the regulatory oversight involves obtaining an MD5 manufacturing license from the State Licensing Authority. This process is designed to ensure that the device meets stringent quality, safety, and performance standards before entering the Indian market.

Risk Classification and License Requirements for Class B Devices

Class B devices present low to moderate risk to users and patients. The CDSCO mandates that manufacturers of such devices secure an MD5 license, which involves comprehensive evaluation including product testing, documentation scrutiny, and an audit conducted by an accredited notified body.

Understanding the exact classification is crucial. You can verify your device’s risk class on our detailed Medical Device Classification resource.

Manufacturing License Process for MD5 (Class B Devices)

The MD5 license process for Class B devices like the Low Energy Ultrasound Wound Cleaner typically spans 3 to 4 months and consists of the following sequential steps:

1. Test License Application (Form MD13): Apply for a test license to manufacture the device for testing purposes. This step generally takes 1.5 to 2 months.

2. Product Testing: Conduct device testing at CDSCO-approved government laboratories to validate safety and performance. Refer to the Testing Laboratories list.

3. Document Preparation: Prepare essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. MD5 License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo a compliance audit by an accredited notified body. Check the Notified Bodies List to select an appropriate auditor.

6. Query Resolution: Address any queries raised during the audit or by the licensing authority promptly.

7. Grant of MD5 License: Upon successful completion, the state authority issues the MD5 manufacturing license.

Manufacturing License Documents Required for Low Energy Ultrasound Wound Cleaner

To ensure a smooth application process, manufacturers should prepare the following key documents:

• Company Constitution Documents: Memorandum and Articles of Association or Partnership Deed
• Proof of Ownership or Tenancy of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Description of the manufacturing facility and quality control systems (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File: Identification and mitigation of potential risks (Risk Management Resource)
• Test Reports from Government Approved Labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: ISO 13485 certification and SOPs

Preparing these documents meticulously reduces the risk of application rejection or delays.

Import License Process (MD15) for Low Energy Ultrasound Wound Cleaner

For importers intending to bring the Low Energy Ultrasound Wound Cleaner into India, obtaining an MD15 import license from the Central Licensing Authority is mandatory. This process generally takes 5 to 6 months and does not require a test license.

Steps involved include:

1. Document Preparation: Collect all necessary documents such as the 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.

2. Submit License Application (Form MD14) via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any queries raised by CDSCO.

4. License Grant: Upon satisfactory review, CDSCO issues the MD15 import license.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent international certification
• Detailed Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Planning your project timeline with these durations in mind helps avoid costly delays.

Government Fees and Costs for MD5 License

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

These fees are payable to the State Licensing Authority via the online portal. Additional costs may include testing fees at government-approved laboratories and audit fees charged by notified bodies.

Common Challenges and Solutions

Challenge 1: Incomplete Documentation

Solution: Engage experienced consultants early for document preparation, ensuring all mandatory files such as Device Master File and Risk Management are comprehensive.

Challenge 2: Delays in Product Testing

Solution: Schedule testing well in advance and select government-approved labs with shorter lead times. Refer to the official Testing Laboratories list.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal audits and mock inspections before the notified body audit. Utilize the Notified Bodies List to choose experienced auditors.

Challenge 4: Query Resolution Delays

Solution: Assign a dedicated regulatory liaison to respond promptly with accurate information.

Expert Consultation and Support

With over 25 years of regulatory consulting experience and having successfully supported 500+ companies, we provide tailored guidance throughout your CDSCO licensing journey. From pre-submission document reviews to audit preparedness and post-license compliance, our expertise ensures a smooth and efficient process.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your Low Energy Ultrasound Wound Cleaner is Class B under CDSCO regulations.

2. Prepare Required Documentation: Utilize our comprehensive guides on Device Master Files and Plant Master Files to assemble your dossiers.

3. Apply for Test License: Initiate the process by submitting Form MD13 on the CDSCO MD Online Portal.

4. Schedule Product Testing: Coordinate with government-approved labs for timely product evaluation.

5. Submit MD5 License Application: After successful testing, apply for manufacturing license on Form MD3.

6. Prepare for Audit: Engage with notified bodies early to schedule and prepare for the audit.

7. Resolve Queries Promptly: Maintain close communication with CDSCO and the auditing body.

Embarking on your CDSCO licensing journey with detailed planning and expert support significantly increases your chances of timely market entry. Contact us today to leverage our extensive experience and dedicated services for your Low Energy Ultrasound Wound Cleaner licensing needs.