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CDSCO Manufacturing License for Image- intensified fluoroscopic x- ray system
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO), is the backbone of India's medical device industry. It serves as the pivotal regulatory authority for ensuring the safety, efficacy and the quality of medical devices manufactured and sold in India. Acquiring a manufacturing license from CDSCO is a crucial step for manufacturers pursuing to deliver excellence in the field of medical devices.
Among thousands of medical devices regulated by CDSCO, an integral one is the Image- intensified fluoroscopic x-ray system. This high-risk class C device is extensively used for visualizing anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. The CDSCO portal link provides comprehensive details regarding the manufacturing license.
- What is Image- intensified fluoroscopic x-ray system?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Image- intensified fluoroscopic x-ray system
- Fees for manufacturing license for Image- intensified fluoroscopic x-ray system
- Why is a Manufacturing License Necessary for Image- intensified fluoroscopic x-ray system?
- Steps to Obtain a CDSCO Manufacturing License for Image- intensified fluoroscopic x-ray system
- Frequently Asked Questions (FAQs)
- Conclusion
What is Image- intensified fluoroscopic x-ray system?
An image-intensified fluoroscopic x-ray system is a radiological device designed to amplify faint x-rays into visible light images. They play a crucial role in various medical procedures to obtain real-time moving images of the patient's anatomy.
The Role of CDSCO in Medical Device Regulation
The development and evolution of the Central Drugs Standard Control Organization roots back towards the mission of protecting public health by ensuring the safety, efficacy, and quality of drugs, cosmetics and medical devices. The organization is the nodal regulatory authority for medical devices in the country and sets up stringent standards that manufacturers must comply with.
How to manufacture Image- intensified fluoroscopic x-ray system
Prior to manufacturing an Image- intensified fluoroscopic x-ray system, it is crucial to obtain a manufacturing license. The license needed for this high-risk class C device is MD9.
Fees for manufacturing license for Image- intensified fluoroscopic x-ray system
The fees for obtaining an MD9 manufacturing license is Rs. 50,000. Additionally, for each product manufactured, there is a fee of Rs. 1,000.
Why is a Manufacturing License Necessary for Image- intensified fluoroscopic x-ray system?
Acquiring a Manufacturing License is mandatory to ensure quality and safety in medical device production. It plays a vital role in enforcing stringent regulatory compliance in the healthcare sector and safeguards consumers from substandard medical devices.
Steps to Obtain a CDSCO Manufacturing License for Image- intensified fluoroscopic x-ray system
- Prepare essential documents including the Device Master File, Quality Management Certificate, Device Details, Site details.
- Submit the application and requisite fee.
- Wait for the approval from CDSCO.
- Overcome challenges if any, abide by the regulations and safety protocols.
Frequently Asked Questions (FAQs)
Q.1. What is risk class of Image- intensified fluoroscopic x-ray system as per Medical Device Rules, 2017?
Class C.
Q.2. What license is needed to manufacture Image- intensified fluoroscopic x-ray system?
MD9 license is required.
Q.3. What is fees for MD9 license for Image- intensified fluoroscopic x-ray system?
The fee for the MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.
Q.4. Who will issue manufacturing license for Image- intensified fluoroscopic x-ray system?
The manufacturing license for Class C devices is issued by the CDSCO Headquarters in New Delhi.
Q.5. Is repackaging of Image- intensified fluoroscopic x-ray system 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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Image- intensified fluoroscopic x-ray system is also considered manufacturing requiring a license on MD9.
Conclusion
Procuring a CDSCO Manufacturing License is a complex process. Understanding each procedure and the compliance with all the regulations could be a daunting task. Reach out to Pharmadocx Consultants for expert guidance and assistance in navigating these processes. Get in touch with us at "+91-7404557227" or drop us an email at "[email protected]".
Read more about MD9 license here.
