Published on

CDSCO Manufacturing License for Cholangiopancreatography catheter, single-use

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national authority in India that controls and permits the manufacture, import, and distribution of medical devices. Its purpose is to ensure that medical devices adhere to predefined standards and that they are safe for consumers. Manufacturing licenses issued by the CDSCO are a critical aspect of the medical device industry as they offer assurance that a product is safe and efficient. One such medical device that requires a CDSCO manufacturing license is the Cholangiopancreatography catheter.

The Cholangiopancreatography catheter, single-use, is a medical device of notable importance due to its critical part in diagnosing disorders related to the pancreas, liver, and gallbladder. This is achieved by its use in a procedure called endoscopic retrograde cholangiopancreatography (ERCP). Specific details about the manufacturing license required for Cholangiopancreatography catheter, single-use, could be found on the official CDSCO's portal here.

What is a Cholangiopancreatography catheter, single-use?

A Cholangiopancreatography catheter is a flexible tube that is used for endoscopic cannulation of the gastrointestinal ductal system. Its primary purpose is to facilitate the performance of ERCP, a procedure that helps diagnose conditions of the liver, gallbladder, and pancreas. This device is made for single use, ensuring it adheres to the highest standards of hygiene and safety.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a pivotal role in the regulation of medical devices in India. Its mandate includes the licensing of manufacturing operations, regulation of imports, and oversight of the post-marketing surveillance of medical devices. This aim is to ensure that all medical devices that reach consumers meet the highest standards of safety and efficiency.

How to manufacture a Cholangiopancreatography catheter, single-use

Manufacturing a Cholangiopancreatography catheter, single-use requires adherence to specific guidelines and regulations as outlined by the CDSCO. The process includes the design of the device, procurement of appropriate materials, assembly, and testing. Additionally, all manufacturing activities undergo rigorous quality control to ensure that the final product meets the desired characteristics.

Fees for manufacturing license for Cholangiopancreatography catheter

The Cholangiopancreatography catheter falls under the Class B risk group, requiring the MD5 license for manufacturing. The fee for this license is Rs. 5,000, with an additional Rs. 500 required for each product. Visit this link for further information.

Why is a Manufacturing License Necessary for Cholangiopancreatography catheter, single-use?

Obtaining a manufacturing license for the Cholangiopancreatography catheter, single-use is mandatory under Indian law. Importantly, the license assures the quality and safety of the medical device, ensuring that it meets all necessary regulations for its intended use. This process protects both consumers and patients from unregulated, potentially harmful products.

Steps to Obtain a CDSCO Manufacturing License for Cholangiopancreatography catheter, single-use

  1. Gathering required documentation such as the Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submitting the application and required documentation.
  3. Waiting for approval from CDSCO or the relevant state FDA.
  4. Overcoming common challenges that might occur, such as discrepancies in documentation or incorrect information provided.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Cholangiopancreatography catheter, single-use as per Medical Device Rules, 2017? Cholangiopancreatography catheter, single-use falls under Class B risk group as per Medical Devices Rules, 2017.

  2. What license is needed to manufacture Cholangiopancreatography catheter, single-use? The MD5 license is required to manufacture Cholangiopancreatography catheter, single-use.

  3. What is the fees for MD5 license for Cholangiopancreatography catheter, single-use? The fee for the MD5 license is Rs. 5,000, with an additional Rs. 500 required for each product.

  4. Who will issue manufacturing license for Cholangiopancreatography catheter, single-use? For Class B devices such as the Cholangiopancreatography catheter, single-use, the state FDA will issue the license.

  5. Is repackaging of Cholangiopancreatography catheter, single-use considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and by extension, medical devices like the Cholangiopancreatography catheter is indeed considered manufacturing.

Conclusion

Acquiring a manufacturing license for a Cholangiopancreatography catheter, single-use might be a challenging process. However, with the right guidance and resources, it is achievable. For consultation or assistance regarding the manufacturing license process, feel free to reach out to Pharmadocx Consultants or call at +91-7404557227 or send an email to [email protected]. Our team of experts will guide you step-by-step, ensuring that you navigate the process with ease.

cdsco import license in india banner
cdsco manufacturing license in india banner