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CDSCO Manufacturing License for Flexible video choledochoscope, single- use

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary regulatory body for pharmaceuticals and medical devices. It is responsible for ensuring that the medicines, medical devices, and cosmetics available in the country are safe, effective, and meet internationally recognized standards of quality. Manufacturing licenses play a vital role in the medical device industry, acting as a guarantee of quality and safety for healthcare professionals and the public.

One such medical device, of great significance in the field of Gastroenterology, is the Flexible Video Choledochoscope. This breakthrough device has revolutionized the way doctors examine and treat disorders of the biliary tract. In this article, we will explain the importance of obtaining a CDSCO manufacturing license for this device and provide detailed information about the licensing process and the necessary fees.

You can access CDSCO's portal for more information here

What is Flexible Video Choledochoscope?

Flexible Video Choledochoscope is an endoscope with a flexible inserted portion designed explicitly for visual examination and treatment of the biliary tract and related ducts. This includes the common bile duct (CBD), cystic duct, and pancreatic duct. The device is also used for the removal of gallstones, making it a quintessential tool in gastroenterology. The incorporation of video capability provides a comprehensive visual representation, leading to more accurate diagnoses and efficient treatments.

The Role of CDSCO in Medical Device Regulation

CDSCO was established with the mission to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. In the case of medical devices, CDSCO has put forth an extensive regulatory framework, stratifying devices into four risk-based classes (A, B, C, D). Each device then requires a specific manufacturing license, either MD5 or MD9, depending on its risk class.

How to manufacture the Flexible Video Choledochoscope

The manufacture of the Flexible Video Choledochoscope requires strict adherence to all the guidelines established by the CDSCO. This ensures that the product meets the globally recognized standards of quality and safety, offering maximum benefits to the patients and healthcare professionals using the device.

Fees for manufacturing license for the Flexible Video Choledochoscope.

Since the Flexible Video Choledochoscope falls under risk Class B, it requires an MD5 manufacturing license. The fee for the license is Rs. 5,000, and there's an additional fee of Rs. 500 per product. More details about the MD5 license can be obtained from this article.

Why is a Manufacturing License Necessary for the Flexible Video Choledochoscope?

A manufacturing license is mandatory for producing medical devices like the Flexible Video Choledochoscope. It not only ensures quality and safety in the production but also underscores the significance of regulatory compliance in the healthcare sector. Moreover, it protects consumers and patients from substandard products, thereby upholding public health standards.

Steps to Obtain a CDSCO Manufacturing License for the Flexible Video Choledochoscope

Obtaining a CDSCO manufacturing license involves several steps:

  1. Gather all prerequisite documents such as the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application to the CDSCO
  3. Wait for CDSCO's evaluation and approval
  4. Address any queries or objections raised by CDSCO

Frequently Asked Questions (FAQs)

  1. What is risk class of the Flexible Video Choledochoscope as per Medical Device Rules, 2017? The Flexible Video Choledochoscope falls under risk Class B.

  2. What license in needed to manufacture the Flexible Video Choledochoscope? Flexible Video Choledochoscope requires an MD5 manufacturing license.

  3. What is the fees for the MD5 license for the Flexible Video Choledochoscope? The fee for the MD5 license is Rs. 5,000, and there's an additional fee of Rs. 500 per product.

  4. Who will issue manufacturing license for the Flexible Video Choledochoscope? For Class B devices like the Flexible Video Choledochoscope, the state FDA will issue the license.

  5. Is repackaging of the Flexible Video Choledochoscope considered manufacturing under CDSCO guidelines? Yes, as per the Drug and Cosmetic Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices such as the Flexible Video Choledochoscope are also considered drugs under this Act. Hence, repackaging would require an MD5 license.

Conclusion

The process of obtaining a manufacturing license for medical devices in India can be a complex one, requiring the careful navigation of regulatory guidelines and requirements. If you need consultation or assistance in obtaining a CDSCO manufacturing license for Flexible Video Choledochoscope, consider reaching out to Pharmadocx Consultants for professional help. Feel free to call us on "+91-7404557227" or email us at "[email protected]".

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