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CDSCO Manufacturing License for Angiographic x- ray system
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Introduction
The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in ensuring public health safety in India by regulating quality and standards of drugs and medical devices. Its comprehensive guidelines and stringent norms have streamlined the manufacturing and distribution of medical devices in the country. One of its core responsibilities includes granting manufacturing licenses for various classes of medical devices. Having a manufacturing license is not just mandatory but also asserts the superiority and safety of the medical devices produced.
One such critical medical device that requires a CDSCO manufacturing license is the Angiographic x-ray system. This highly sophisticated and powerful equipment plays a vital role in diagnosing and managing vascular conditions. For more details on CDSCO's regulations and guidelines, one can visit the organisation's portal, CDSCO
- What is Angiographic x- ray system?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Angiographic x-ray system
- Fees for manufacturing license for Angiographic x- ray system
- Why is a Manufacturing License Necessary for Angiographic x-ray system
- Steps to Obtain a CDSCO Manufacturing License for Angiographic x- ray system
- Frequently Asked Questions (FAQs)
- Conclusion
What is Angiographic x- ray system?
Angiographic x-ray system is a specialised radiological device used for visualising the heart, lymphatic system, and blood vessels under certain circumstances. This imaging technique involves the injection of a contrast medium, which helps in viewing these structures in detail.
Angiography helps healthcare professionals in diagnosing and managing several vascular conditions, such as blood clots, arteriovenous malformations, and even heart diseases. It aids not only in diagnostic procedures but also serves as a guiding tool during interventional procedures.
The Role of CDSCO in Medical Device Regulation
Since its inception, CDSCO has been committed to safeguarding public health in India by ensuring only the highest-quality and safest drugs and medical devices are available in the market. CDSCO's regulatory framework for medical devices is structured, relying on the risk level associated with each device. It categorises medical devices into four risk classes - Class A, B, C, and D, with Class A having the lowest risk and Class D the highest.
How to manufacture Angiographic x-ray system
As per CDSCO's guidelines, any manufacturer intending to produce Class C device such as Angiographic X-Ray System is required to obtain an MD9 manufacturing license.
Fees for manufacturing license for Angiographic x- ray system
For acquiring an MD9 license for manufacturing Angiographic X-ray system, you would need to pay Rs. 50,000 for the license and Rs. 1,000 per product. For more details refer to this article.
Why is a Manufacturing License Necessary for Angiographic x-ray system
Obtaining a manufacturing license for a device such as an Angiographic X-ray System is not only mandatory but also crucial for numerous reasons. This includes ensuring quality standards, safeguarding public health, maintaining regulatory compliance, and protecting consumers and patients from substandard products.
Steps to Obtain a CDSCO Manufacturing License for Angiographic x- ray system
The process for obtaining a manufacturing license includes certain pre-requisites such as the submission of Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application process involves submission, assessment, and final approval. It is important to be aware of potential stumbling blocks and know how to overcome them.
Frequently Asked Questions (FAQs)
Q1. What is risk class of Angiographic x-ray system as per Medical Device Rules, 2017? A. The Angiographic X-ray system falls under Class C as per Medical Device Rules, 2017.
Q2. What license is needed to manufacture Angiographic x-ray system? A. An MD9 license is required to manufacture the Angiographic X-ray system.
Q3. What is fees for MD9 license for Angiographic x-ray system? A. The fee for an MD9 license for manufacturing an Angiographic x-ray system is Rs. 50,000 for the license and Rs. 1,000 per product.
Q4. Who will issue a manufacturing license for Angiographic x-ray system? A. For Class C devices like the Angiographic x-ray system, the CDSCO HQ in New Delhi will issue the manufacturing license.
Q5. Is repackaging of Angiographic x-ray system considered manufacturing? A. 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 Angiographic x-ray system is also considered manufacturing requiring a license on MD9.
Conclusion
Navigating the often complex world of medical device licensing and regulation can be intimidating. Professionals at Pharmadocx Consultants are here to help. For consultation or assistance regarding the licensing process, feel free to call us at "+91-7404557227" or email us at "[email protected]".
