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CDSCO Manufacturing License for Battery-powered trephine system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body in India for the regulation of medical devices and drugs. The chief function of CDSCO is to ensure the safety, efficacy and quality of health commodities that are available to the public. It achieves this by enforcing stringent standards for the medical device industry. A critical part of this enforcement is the requirement for obtaining manufacturing licenses for the production of medical devices.

In the world of medical devices, Battery-powered trephine systems are vital, particularly in the field of dermatological and plastic surgery. These devices play a critical role in various medical procedures, ensuring precision and safety. An understanding of the regulatory framework needed for their manufacture is essential for adherence to quality standards. Visit the official CDSCO portal for updated information: CDSCO Portal

What is a Battery-powered trephine system?

A Battery-powered trephine system is a rotary surgical device which consists of an engine and a cylindrical or trephine insertion part. These systems offer extreme precision and are commonly used for the removal of intervertebral discs, hard tissues or soft tissues. They are often equipped with a speed control device to increase their functionality and safety. Battery-powered trephine systems find their purposes primarily within the fields of dermatological and plastic surgery.

The Role of CDSCO in Medical Device Regulation

The mission of CDSCO includes regulating the manufacturing, sales and distribution of drugs and medical devices. Providing licenses to ensure standard and quality across all medical devices is a part of their regulatory framework. Medical devices such as the Battery-powered trephine system fall under this purview and require specific licenses to be manufactured.

How to manufacture a Battery-powered trephine system

To be discussed...

Fees for manufacturing license for a Battery-powered trephine system

The Battery-powered trephine system falls under Risk Class B, for which a MD5 license is required. The fees for obtaining this license are Rs. 5000 for the license and Rs. 500 per product manufactured.

Why is a Manufacturing License Necessary for a Battery-powered trephine system?

Manufacturing licenses are crucial for the production of medical devices like the Battery-powered trephine system. They are required by law and ensure that the manufacturing of these devices adheres to quality standards, guaranteeing safety and efficacy. The license stems from the need for regulatory compliance within the healthcare sector, protecting consumers and patients from subpar products.

Steps to Obtain a CDSCO Manufacturing License for a Battery-powered trephine system

The process of obtaining a manufacturing license from CDSCO involves several steps and requires specific documentation. Essential documents include Device Master File, Quality Management Certificate, Device Details, Site details, etc.

To avoid common challenges during the application process, it is crucial to ensure that all requirements are fulfilled on time with diligent submission of the necessary documentation.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Battery-powered trephine system as per Medical Device Rules, 2017?

Risk Class B.

Q2. What license is needed to manufacture a Battery-powered trephine system?

MD5 license.

Q3. What is the fees for the MD5 license for a Battery-powered trephine system?

Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue a manufacturing license for a Battery-powered trephine system?

For Class B devices like the Battery-powered trephine system, the state FDA will issue the license.

Q5. Is repackaging of a Battery-powered trephine system considered manufacturing?

Yes, under the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Similarly, medical devices like the Battery-powered trephine system also fall under this category. Thus, repackaging would require an MD5 license.

Conclusion

Understanding the medical device regulatory landscape can be complex and time-consuming. If you need assistance in the licensing process for the Battery-powered trephine system or any other medical device, we recommend reaching out to the expert consultants at Pharmadocx Consultants. They can provide you with the necessary guidance to ensure a smooth licensing process. You can contact them on +91-7404557227 or send an email to [email protected].

For more information on MD5 License for Class B medical devices such as the Battery-powered trephine system, follow this link - MD5 License Class A/B Medical Devices.

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