CDSCO Manufacturing License for Low energy ultrasound wound cleaner

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the principal body governing the quality of medicines and medical devices in India. The manufacturing licenses issued by this organization serve to ascertain that all medical devices produced within the country abide by the necessary quality and safety standards.

One such medical device that requires CDSCO manufacturing license for production is the Low energy ultrasound wound cleaner. Recognized for its significant role in Dermatological and Plastic surgery, this device uses ultrasound energy to vaporize a solution and generate a mist that is instrumental for the cleaning and maintenance debridement of wounds.

To gain more information about the CDSCO and its services, you can make use of CDSCO's portal here.

• What is a Low energy ultrasound wound cleaner?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture a Low energy ultrasound wound cleaner
• Fees for manufacturing license for a low energy ultrasound wound cleaner
• Why is a Manufacturing License Necessary for a Low energy ultrasound wound cleaner?
• Steps to Obtain a CDSCO Manufacturing License for a low energy ultrasound wound cleaner
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Low energy ultrasound wound cleaner?

A low energy ultrasound wound cleaner is a specialized tool used in the medical field, particularly in dermatological and plastic surgery practices. It utilizes ultrasound energy to create a vaporized solution which, when condensed, forms a mist. This mist is then directed towards wounds with the intention of cleaning them and keeping them free from debris.

The low energy ultrasound wound cleaner aids in the facilitation of quicker wound healing and minimization of infection risks. It is commonly invoked in procedures that entail wound care such as surgeries, burns treatments, and trauma cases.

The Role of CDSCO in Medical Device Regulation

The CDSCO, has been crucial in assuring the safety, effectiveness, and quality of drugs, cosmetics, and medical devices in India. It is involved in various activities like granting approval for clinical trials, marketing of new drugs, and overseeing the standards of imported drugs and vaccines.

When it comes to regulating medical devices, CDSCO follows a detailed and comprehensive framework. Given the diverse nature and varying risk levels of medical devices, they are broadly categorized into four classes - A, B, C, and D. Class A is considered as the lowest risk class and Class D as the highest. The low energy ultrasound wound cleaner falls under Class B risk category.

How to manufacture a Low energy ultrasound wound cleaner

Manufacturing a low energy ultrasound wound cleaner involves following a variety of processes, each designed to ensure the quality and safety of the end product. It begins with a thorough understanding of the design and functional requirements of the device, followed by the material selection process. After completing the preliminary steps, manufacturing can commence under regulated conditions that meet the standards set by the CDSCO.

Fees for manufacturing license for a low energy ultrasound wound cleaner

As the low energy ultrasound wound cleaner falls under the Class B risk category, an MD5 license is required for its manufacturing. The costs associated with this license include an initial license fee of Rs. 5,000 and a product fee of Rs. 500 for each device.

MD5 License cost details are available here

Why is a Manufacturing License Necessary for a Low energy ultrasound wound cleaner?

A manufacturing license is legally mandatory for producing any medical device, including the low energy ultrasound wound cleaner. Alongside legal adherence, this requirement also ensures the production of high-quality and safe devices. The regulatory compliance upheld in the healthcare sector keeps patients and consumers shielded from the jeopardy of substandard products.

Steps to Obtain a CDSCO Manufacturing License for a low energy ultrasound wound cleaner

Obtaining a CDSCO manufacturing license involves a detailed process that includes submitting documents such as Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application subsequently undergoes a rigorous scrutiny by the CDSCO followed by the granting of the license if all conditions are met. It's important to navigate this process with meticulousness as challenges may arise.

Frequently Asked Questions (FAQs)

1. What is the risk class of a Low energy ultrasound wound cleaner as per Medical Device Rules, 2017?
   The Low energy ultrasound wound cleaner falls under Class B risk category.

2. What license is needed to manufacture a Low energy ultrasound wound cleaner?
   An MD5 license is required to manufacture this device.

3. What is the fees for MD5 license for Low energy ultrasound wound cleaner?
   The fees for an MD5 license include an initial license fee of Rs. 5,000 and a per product fee of Rs. 500.

4. Who will issue manufacturing license for Low energy ultrasound wound cleaner?
   The manufacturing license for Class B devices like Low energy ultrasound wound cleaner will be issued by the state FDA.

5. Is repackaging of Low energy ultrasound wound cleaner considered manufacturing?
   Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Low energy ultrasound wound cleaner is also considered manufacturing requiring a license of MD5.

Conclusion

Navigating through the intricacies of obtaining a manufacturing license can be a daunting task. However, the expert team at Pharmadocx Consultants is here to assist you. Reach out to us by calling on "+91-7404557227" or email us at "[email protected]" for guidance on this process.