CDSCO Manufacturing License for Non-image- intensified fluoroscopic x- ray system

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the significant pharmaceutical and medical device regulatory body in India. Its primary functions include approving new drugs, regulating drug manufacturing, sales, and distribution, awarding licenses, and maintaining vigilance over product quality. If aimed at the local or international market, Indian manufacturers are mandated to follow CDSCO guidelines for the production and licensing of medical devices.

Manufacturing licenses play a vital role within the industry. They provide the legal ground for pharmaceutical and medical device companies to engage in production activities. Moreover, they ensure the adherence of manufacturers to standards that ensure quality, effectiveness, and safety of medicinal products and medical devices, such as Non-image- intensified fluoroscopic x- ray system, a significant device in the field of radiology. For more information about such devices and the procedures for acquiring a manufacturing license, one may visit the CDSCO's portal here.

• What is Non-image- intensified fluoroscopic x-ray system?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Non-image- intensified fluoroscopic x-ray system
• Fees for manufacturing license for Non-image- intensified fluoroscopic x-ray system
• Why is a Manufacturing License Necessary for Non-image- intensified fluoroscopic x-ray system?
• Steps to Obtain a CDSCO Manufacturing License for Non-image- intensified fluoroscopic x-ray system
• Frequently Asked Questions (FAQs)
• Conclusion

What is Non-image- intensified fluoroscopic x-ray system?

A Non-image-intensified fluoroscopic x-ray system falls under the category of Radiology in medical devices. This device is intended to create a visible image through fluorescence by converting x-radiation into a visible light component. It allows physicians to visualize anatomical structures during diagnostic and treatment procedures.

The Role of CDSCO in Medical Device Regulation

Since its inception, the CDSCO aims to ensure the quality, effectiveness, and safety of pharmaceutical products and medical devices in India. It adopts a comprehensive regulatory framework for medical devices that covers their manufacture, import, distribution, and sale. The CDSCO continuously strengthens its regulatory system to address emerging challenges in healthcare and to protect public health.

How to manufacture Non-image- intensified fluoroscopic x-ray system

The manufacturing of a Non-image- intensified fluoroscopic x-ray system requires compliance with appropriate manufacturing procedures and quality specifications. It is a complex process that necessitates proper training, standards, and safety measures.

Fees for manufacturing license for Non-image- intensified fluoroscopic x-ray system

The Non-image- intensified fluoroscopic x-ray system is a Class C device, thus it requires an MD9 license, which costs Rs. 50,000 for the license fee and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Non-image- intensified fluoroscopic x-ray system?

A manufacturing license is a mandatory requirement by law for manufacturers. It ensures that the Non-image- intensified fluoroscopic x-ray system is produced according to the highest safety and quality standards. Adherence to regulatory compliance protects consumers and patients from substandard products, therefore upholding the integrity of the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Non-image- intensified fluoroscopic x-ray system

1. Prepare all the necessary documents such as Device Master File, Quality Management Certificate, Device Details, Site details etc.
2. Submit the application and all the requirements to CDSCO.
3. Wait for the evaluation and approval of the application.
4. Address any challenges and issues that may arise during the application process.

For more detailed information about the licensing procedure for Class C medical devices, refer to this article.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Non-image- intensified fluoroscopic x-ray system as per Medical Device Rules, 2017?
The Non-image- intensified fluoroscopic x-ray system is classified as a Class C device.

Q2. What license in needed to manufacture Non-image- intensified fluoroscopic x-ray system?
An MD9 license is needed to manufacture Non-image- intensified fluoroscopic x-ray system.

Q3. What is fees for MD9 license for Non-image- intensified fluoroscopic x-ray system?
The fee for an MD9 license for Non-image- intensified fluoroscopic x-ray system is Rs. 50,000 for the license fee and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Non-image- intensified fluoroscopic x-ray system?
The manufacturing license will be issued by CDSCO HQ in New Delhi for Class C devices.

Q5. Is repackaging of Non-image- intensified fluoroscopic x-ray system considered manufacturing?
Yes. According to the Drugs and Cosmetics Act, repackaging is considered as manufacturing. As per this Act, medical devices are also considered drugs. Thus, repackaging the Non-image- intensified fluoroscopic x-ray system requires an MD9 license.

Conclusion

Navigating the regulatory landscape for manufacturing medical devices such as the Non-image- intensified fluoroscopic x-ray system in India may be challenging. But with the right guidance, acquiring the necessary licenses can be managed seamlessly. Our team of consultants at Pharmadocx is ready to help. Reach out to us at Pharmadocx Consultants or call at [+91-7404557227] or email us at [[email protected]] for assistance.