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CDSCO Manufacturing License for Flexible video choledochoscope

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the healthcare sector, particularly in regulating the manufacturing, import, and distribution of medical devices in India. It maintains a rigorous process of licensing to ensure safety, quality, and efficacy standards are met. This is critically significant when it comes to medical devices like the Flexible video choledochoscope, a critical tool used widely in Gastroenterology.

The manufacturing license provided by the CDSCO helps to protect both manufacturers and consumers by ensuring that only quality products are made available in the market. These regulations safeguard public health by guaranteeing that medical devices used for diagnostic, therapeutic or surgical purposes are safe and effective. To explore more about CDSCO's regulatory procedures, visit their online portal: CDSCO online portal

What is Flexible video choledochoscope?

The flexible video choledochoscope is an advanced medical device designed to visually examine and treat the choledoch, a duct that carries bile from the liver to the small intestine (duodenum). Enhanced by video capability, this gadget helps medical professionals perform intricate procedures, enabling them to diagnose and treat conditions affecting the bile ducts and other parts of the digestive system more accurately and effectively.

The Role of CDSCO in Medical Device Regulation

Established under the Drugs and Cosmetics Act, 1940, the CDSCO is the National Regulatory Authority (NRA) of India that ensures the safety, efficacy, and quality of medical products manufactured, imported, and distributed in India. In the realm of medical devices, CDSCO has devised a well-structured regulatory framework to oversee and control their production under the provisions of Drugs and Cosmetic Rules, 1945.

How to manufacture Flexible video choledochoscope

The manufacturing process of a Flexible video choledochoscope involves numerous strict regulatory compliances set by CDSCO. As a Class B medical device, the manufacturing license required for its production is MD5.

Fees for manufacturing license for Flexible video choledochoscope

Given that the Flexible video choledochoscope falls under Class B, the fee for its manufacturing license, MD5 is Rs. 5,000 and an additional charge of Rs. 500 per product.

Why is a Manufacturing License Necessary for Flexible video choledochoscope?

The manufacturing license is a strict mandate set by the regulatory authority, CDSCO, to ensure that the gadgets are produced in compliance with the safety and quality norms. Besides, it significantly contributes to upholding public health by protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Flexible video choledochoscope

Obtaining a manufacturing license involves pre-requisites like submitting the Device Master File, Quality Management Certification, Device Details, Site details, etc. The application process includes submission, evaluation, and approval stages, and it's not always smooth. However, with the right guidance, it's possible to overcome these challenges. To know more about the licensing process, refer to this article - MD5 license.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of the Flexible video choledochoscope as per Medical Device Rules, 2017?

    A: The Flexible video choledochoscope has been classified as a Class B device.

  2. Q: What license is needed to manufacture a Flexible video choledochoscope?

    A: The manufacturing of a Flexible video choledochoscope requires an MD5 license.

  3. Q: What is the fee for an MD5 license for a Flexible video choledochoscope?

    A: The license fee for MD5 is Rs. 5,000 and Rs. 500 per product.

  4. Q: Who will issue the manufacturing license for a Flexible video choledochoscope?

    A: For Class B devices like Flexible video choledochoscope, the state FDA will issue the license.

  5. Q: Is repackaging of a Flexible video choledochoscope 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. Therefore, repackaging of a Flexible video choledochoscope also necessitates a license on MD5.

Conclusion

The CDSCO plays a significant role in regulating medical devices in India, and a deep understanding of the various procedures and requirements can ensure a smooth licensing process. If you need help navigating this robust landscape or require more personalized consulting services, reach out to us at Pharmadocx Consultants or call us at +91-7404557227 or email us at [email protected]. We will be more than willing to assist you.

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