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CDSCO Manufacturing License for Flexible video oesophagoscope, reusable

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in regulating medical devices in India. It's a regulatory body that oversees the quality and safety of drugs and medical devices, ensuring they meet international safety standards. One of their imperative roles involves issuing manufacturing licenses crucial in the medical device industry.

Today, we will dive into the specifics of manufacturing the Flexible video oesophagoscope, reusable. This device has significant medical importance and falls under risk Class B category. We will provide insights on its intended use, risk class, and category, all through this comprehensive guide. For more information, you can visit the official CDSCO portal here.

What is a Flexible Video oesophagoscope, reusable?

The Flexible video oesophagoscope, reusable, is essentially an endoscope manufactured with a flexible inserted portion designed for visual examinations and treatments of the oesophagus. The device enters the body through the mouth, capturing anatomical images via an incorporated camera at its distal end. These images then project onto a monitor for further assessments. This type of oesophagoscope is extensively used for examining tissue structure abnormalities and oesophagus mucous lining. As its name suggests, it's a reusable medical device.

The Role of CDSCO in Medical Device Regulation

CDSCO's mission is to safeguard and enhance public health in India by ensuring the quality, safety, efficiency, and efficacy of drugs, cosmetics, and medical devices. Established over 50 years' ago, CDSCO has been instrumental in developing regulatory frameworks for medicines and medical devices alike. Notably for medical devices, it categorizes them into four risk classes (A, B, C, D) based on potential health risks where Class A being the lowest risk and Class D the highest.

How to Manufacture Flexible Video oesophagoscope, reusable

In understanding the complexities involved in manufacturing a medical device like the Flexible video oesophagoscope, reusable, it's important to note that it falls under risk class B. Therefore, this device requires an MD5 manufacturing license as dictated by CDSCO regulatory framework.

Fees for Manufacturing License for Flexible Video Oesophagoscope, Reusable

To manufacture the Flexible Video oesophagoscope, reusable, applicants need to acquire an MD5 license which has a fee structure of Rs. 5,000 for the license and Rs. 500 per product. You can learn more about the MD5 license here.

Why is a Manufacturing License Necessary for Flexible Video Oesophagoscope, Reusable?

Acquiring a manufacturing license, in this case, an MD5 license for manufacturing the Flexible video oesophagoscope, reusable, is mandatory. It ensures quality control and safety in medical device production while underlining regulatory compliance in the healthcare sector. This, in turn, safeguards healthcare consumers and patients from potential harm caused by substandard medical products.

Steps to Obtain a CDSCO Manufacturing License for Flexible Video Oesophagoscope, Reusable

Before applying for a license, certain pre-requisites and documentation are required. This includes Device Master File, Quality Management Certificate, Device Details, Site details etc. The application process involves submitting all the necessary documents, waiting for approval, and overcoming common challenges.

  1. Faqs

  • Q: What is the risk class of "Flexible video oesophagoscope, reusable" as per Medical Device Rules, 2017? A: The risk class of "Flexible video oesophagoscope, reusable" is Class B.

  • Q: What license is needed to manufacture "Flexible video oesophagoscope, reusable"? A: An MD5 license is required to manufacture "Flexible video oesophagoscope, reusable".

  • Q: What is the fees for MD5 license for "Flexible video oesophagoscope, reusable"? A: The fees for an MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

  • Q: Who will issue the manufacturing license for "Flexible video oesophagoscope, reusable"? A: For Class B devices, like "Flexible video oesophagoscope, reusable", the state FDA will issue the license.

  • Q: Is repackaging of "Flexible video oesophagoscope, reusable" considered manufacturing? A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Therefore, repackaging of "Flexible video oesophagoscope, reusable" is also considered manufacturing requiring an MD5 license.

Conclusion

Acquiring a manufacturing license for medical devices can seem daunting. We'd like to remind you that you're not alone in navigating this process. Feel free to reach out for consultation or assistance regarding the licensing process with Pharmadocx Consultants. Connect with them here, call them at +91-7404557227, or email at [email protected].

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