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CDSCO Manufacturing License for Externally-propelled flexible video colonoscope

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Introduction

The Central Drugs Standard Control Organization (CDSCO), the apex drug regulatory body in India, plays a crucial role in ensuring the safety, efficacy, and quality of medical devices produced within its jurisdiction. A pivotal part of that role involves issuing manufacturing licenses for medical devices, thereby ascertaining that these crucial health products meet stringent quality checks and have undergone rigorous testings.

One such medical device that has revolutionized the field of gastroenterology is the Externally-propelled flexible video colonoscope, a class B, non-sterile endoscope designed for adult colon examination. This article provides comprehensive details about this device and guides you through the necessities to manufacture it, including obtaining the requisite CDSCO licenses. To facilitate your understanding, we will link the CDSCO's portal here.

What is an Externally-propelled flexible video colonoscope?

An Externally-propelled flexible video colonoscope is a sophisticated non-sterile endoscope that offers a visual examination of the complete adult colon, a key component of the lower gastrointestinal (GI) tract. By providing an inside view, this device empowers physicians to identify, diagnose, and if needed, perform therapeutic procedures on potential health issues associated with the colon.

This device is predominantly used in colonoscopy procedures. A colonoscopy is a medical diagnostic procedure used to detect abnormalities or changes in the lower part of the gastrointestinal tract. It is capable of detecting early signs of colon cancer, confirm the presence of inflammatory bowel diseases, and offer therapeutic intervention like removal of polyps etc.

The Role of CDSCO in Medical Device Regulation

Establishing and maintaining high-quality standards in the larger healthcare domain is the key responsibility of CDSCO. Originated from the Drugs and Cosmetics Act, 1940, CDSCO today regulates the manufacture, import, conduct of clinical trials, laying down standards, sale and distribution of drugs and cosmetics under this act.

CDSCO’s regulatory framework for medical devices is divided into four risk classes – A, B, C, D. Externally-propelled flexible video colonoscope falls under the category of Class B devices, assigning that this device is of moderate risk, requiring stringent regulatory control to assure safety, quality, and performance.

How to manufacture an Externally-propelled flexible video colonoscope

In order to manufacture this Class B device, specific guidelines and regulatory requirements need to be followed. The manufacturing process involves various phases, starting from modeling and testing and finally acquiring the license from the drug regulatory authority. Adherence to quality management system and bio-compatibility testing are some of the crucial aspects.

Fees for Manufacturing License for Externally-propelled flexible video colonoscope

For manufacturing an Externally-propelled flexible video colonoscope, a Class B device, you’ll need an MD5 license. The fees structure for this license is as follows:

  • License fee: Rs. 5,000
  • Per Product fee: Rs. 500

Check out here for more details.

Why is a Manufacturing License Necessary for Externally-propelled flexible video colonoscope

Being a mandatory requirement, a manufacturing license ensures that the device is safe and upholds its performance. It reinforces quality and safety in the production of medical devices, promoting transparency and trust. This compulsory tool acts as a regulatory compliance in the healthcare sector thus protecting consumers and patients from substandard or misleading products.

Steps to Obtain a CDSCO Manufacturing License for Externally-propelled flexible video colonoscope

The process of procuring a CDSCO manufacturing license involves these steps:

  1. Device Master File
  2. Acquire Quality Management Certificate
  3. Provide Detailed Device Description
  4. Site details

Despite these steps being seemingly straightforward, there can be unexpected challenges. An experienced regulatory consultant can be a valuable asset through this process.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of Externally-propelled flexible video colonoscope as per Medical Device Rules, 2017?
    A: It is classified as Risk Class B.

  2. Q: What license is needed to manufacture Externally-propelled flexible video colonoscope?
    A: An MD5 license is required to manufacture Externally-propelled flexible video colonoscope.

  3. Q: What is the fees for MD5 license for Externally-propelled flexible video colonoscope?
    A: The license fee for MD5 is Rs. 5,000 and the per product fee is Rs. 500.

  4. Q: Who will issue the manufacturing license for Externally-propelled flexible video colonoscope?
    A: For Class B devices like the Externally-propelled flexible video colonoscope, the state FDA will issue the license.

  5. Q: Is repackaging of Externally-propelled flexible video colonoscope 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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Externally-propelled flexible video colonoscope is also considered manufacturing requiring an MD5 license.

Conclusion

Understanding the importance and need for a medical device license can be a complex process. At Pharmadocx Consultants, we're committed to making this easier for you. Our team of experts can guide you through each step of the licensing process, from understanding the need for a license to completing the application process.

Have a question or need clarification? Don’t hesitate to reach out to us at Pharmadocx Consultants or call us on +91-7404557227 or send us an email to [email protected]. We provide assistance on all regulatory services and will simplify the process for you. Let us guide your way to regulatory compliance!

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