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CDSCO Manufacturing License for Cine or spot fluorographic x- ray camera

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Introduction

The Central Drugs Standard Control Organization, often known as CDSCO, plays a crucial role in the Indian healthcare ecosystem. Acting as the national regulatory body for Indian pharmaceuticals and medical devices, CDSCO is charged with ensuring the quality, safety, and efficacy of these products. It is also responsible for the issuance of licenses, in this specific instance, medical device licenses, which ensure compliance with both national and international standards in the healthcare sector.

In the realm of medical devices, the manufacturing license is of paramount importance. The process of obtaining the license demonstrates a manufacturer's commitment to upholding health and safety standards, stimulating trust among consumers and medical professionals. In essence, the manufacturing license serves as a testament to the quality, efficacy, and safety of a medical device.

We will be discussing Cine or spot fluorographic x-ray camera, its significance, the role CDSCO plays in medical device regulation, the manufacturing license required, its fees, and why such a license is essential. For more information, kindly refer to the CDSCO portal.

What is Cine or spot fluorographic x-ray camera?

A cine or spot fluorographic x-ray camera is used within the medical field to capture diagnostic images produced by x-rays functioning along with an image intensifier. It's essentially a medical imaging device capable of presenting real-time moving pictures of internal structures within the human body.

Common applications of a cine or spot fluorographic x-ray camera include creating detailed visual images of organs, bones, and tissues, aiding doctors in conducting comprehensive diagnostic analyses or guiding invasive procedures.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a pivotal role in regulating the manufacturing, sale, and distribution of medical devices, including ciné or spot fluorographic x-ray cameras, within India's borders. The organization is committed to ensuring the safety, efficacy, and quality of medical devices, safeguarding the public health of Indian citizens.

The CDSCO adopts a risk-based regulatory framework for medical devices. This system is designed to ensure that the safety requirements and regulatory controls are proportional to the potential risks posed by the respective medical device.

How to manufacture Cine or spot fluorographic x-ray camera

To manufacture a cine or spot fluorographic x-ray, a comprehensive understanding and adherence to various guidelines and regulations is necessary. Detailed documentation and proper approval procedures are essential. Abiding by the manufacturing process will ensure production of efficient and standard quality medical devices.

Fees for manufacturing license for Cine or spot fluorographic x-ray camera

As a Class C device, a cine or spot fluorographic x-ray camera requires an MD9 license to manufacture. The fees for this license are Rs. 50,000, with an additional fee of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Cine or spot fluorographic x-ray camera?

Acquiring a manufacturing license for a cine or spot fluorographic x-ray camera is not just an administrative obligation. It's essential to ensure that the medical device produced aligns with the high standards of safety, quality, and efficacy that govern the healthcare sector.

A medical device manufacturing license further promotes regulatory compliance, an integral aspect of operating within the healthcare sector. Moreover, it provides a means of patient protection against substandard products, guaranteeing the continued provision of high-quality healthcare services.

Steps to Obtain a CDSCO Manufacturing License for Cine or spot fluorographic x-ray camera

Acquiring a manufacturing license requires a meticulous procedure that involves multiple steps:

  1. Preparation of the necessary documentation - Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submission of all relevant documents through the CDSCO portal.
  3. Patient waiting for approval from the regulatory body.
  4. Overcoming any challenges that may arise, and navigating any required revisions successfully.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Cine or spot fluorographic x-ray camera as per Medical Device Rules, 2017? A Cine or spot fluorographic x-ray camera belongs to risk class C as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Cine or spot fluorographic x-ray camera? An MD9 license is needed to manufacture a Cine or spot fluorographic x-ray camera.

Q3. What is fees for MD9 license for Cine or spot fluorographic x-ray camera? The fees for an MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Cine or spot fluorographic x-ray camera? The CDSCO HQ in New Delhi will issue the manufacturing license for Ciné or spot fluorographic x-ray camera, being a Class C device.

Q5. Is repackaging of Cine or spot fluorographic x-ray camera considered manufacturing? Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. As per the same definition, the repackaging of Cine or spot fluorographic x-ray camera falls under manufacturing, thereby requiring an MD9 license.

Conclusion

Navigating the maze of manufacturing licenses, particularly in the medical device sector, can be a challenging task. Nevertheless, a nuanced understanding of these processes is crucial to ensure compliance, safety, and efficacy. Our team at Pharmadocx Consultants is geared to provide consultation or assistance regarding the intricate processes of licensing. Don't hesitate to reach out – give us a call at +91-7404557227, send us an email to [email protected], or visit our articles about MD9 license. We're here to guide you every step of the way!

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