CDSCO Manufacturing License for Fluorescent scanner

Introduction

The Central Drugs Standard Control Organization (CDSCO) functions as the national regulatory body for Indian pharmaceuticals and medical devices. Its responsibilities encompass ensuring quality measures, safety, and efficacy of drugs, cosmetics, diagnostics, and devices that are available to Indian consumers. In a similar vein, CDSCO oversees the regulation and standards of manufacturing licenses, which play a critical role in the medical device industry.

This post offers an extensive insight into the process for acquiring the CDSCO manufacturing license for the Fluorescent scanner, a radiology device classified under risk class C. Medical devices, such as the Fluorescent scanner, profoundly impact healthcare and patient treatment progressions. A more detailed understanding of this device and the license requisites can be found on CDSCO's official portal.

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

What is Fluorescent Scanner?

A Fluorescent scanner is a medical device designed to measure induced fluorescent radiation in the body. It achieves this by exposing the body to certain x-rays or low-energy gamma rays. This distinct measurement technology is employed across medical establishments for various procedures and is integral to the realm of healthcare and diagnostics.

The Role of CDSCO in Medical Device Regulation

CDSCO, by virtue of its regulatory framework, influences the medical device industry strongly. Its mission lies in achieving the highest standards in public healthcare by regulating efficient, transparent, and accountable product approval. Its regulations for medical devices are designed to facilitate innovation while assuring safety, effectiveness, and conformance with essential principles of quality management.

How to manufacture Fluorescent Scanner

Fluorescent Scanner, due to its risk class C categorization, requires adherence to stringent guidelines and protocols for manufacturing. This includes adherence to safety standards, quality control, and periodical audits.

Fees for manufacturing license for Fluorescent Scanner

To manufacture Fluorescent Scanner, an MD9 license is needed. The fees for this license are Rs. 50,000 along with Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Fluorescent Scanner?

A CDSCO manufacturing license is obligatory for producing Fluorescent Scanners. This license upholds the standards in medical device production, ensuring quality and safety. Moreover, regulatory compliance in the healthcare sector is critical to protect consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Fluorescent Scanner

Acquiring a CDSCO Manufacturing License for Fluorescent Scanner involves:

1. Coming up with the Device Master File and Quality Management certificate.
2. Meeting site detail requirements along with providing device details.
3. Submitting application and awaiting approval.
4. Navigating any challenges that may arise during the process, with proper consultation and guidance.

Frequently Asked Questions (FAQs)

1. What is the risk class of Fluorescent Scanner as per Medical Device Rules, 2017?

   Risk class of Fluorescent Scanner is class C.

2. What license is needed to manufacture Fluorescent Scanner?

   An MD9 license is required to manufacture Fluorescent Scanner.

3. What is the cost of an MD9 license for a Fluorescent Scanner?

   For an MD9 license, the fee will be Rs. 50,000 for the license and Rs. 1,000 per product.

4. Who will issue manufacturing license for Fluorescent Scanner?

   For class C devices like the Fluorescent Scanner, CDSCO HQ in New Delhi will issue the license.

5. Is repackaging of Fluorescent Scanner 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. Therefore, repackaging of Fluorescent Scanner is also considered manufacturing, requiring an MD9 license.

Conclusion

The CDSCO Manufacturing License is a nuanced process requiring an understanding of the risk classification, the right paperwork, and the corresponding fee structure. At Pharmadocx Consultants, we are well-equipped to guide you through this process, whether you're interested in manufacturing Fluorescent Scanners or another medical device. Feel free to reach out to us for consultation or assistance regarding the licensing process. Visit our website Pharmadocx Consultants or call us on +91-7404557227, or write an email to [email protected].

For more information about MD9 manufacturing license visit this article.