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CDSCO Manufacturing License for Endoscopic needleless submucosal lift catheter

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Introduction

The Central Drugs Standard Control Organization (CDSCO), India's main regulatory body for pharmaceuticals and medical devices, plays a pivotal role in ensuring the quality, safety, and efficacy of medical devices used across the country. One key element of this role is the issuing of manufacturing licenses, a crucial step in the medical device industry that helps maintain high standards and protect the health of patients everywhere.

Today, we will be discussing the Endoscopic Needleless Submucosal Lift Catheter, a medical device that has significant applications in the field of gastroenterology. For more details on the CDSCO and its regulatory process for medical devices, visit their official portal here.

What is The Endoscopic Needleless Submucosal Lift Catheter?

The Endoscopic Needleless Submucosal Lift Catheter is a sterile, flexible tube designed to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract. This device is primarily used during flexible endoscopic procedures like gastroscopy and colonoscopy to lift a lesion, generally for subsequent excision. This action aids in easier and safer removal of early-stage tumors and other potentially harmful lesions in the gastrointestinal tract.

The Role of CDSCO in Medical Device Regulation

CDSCO, is the national regulatory body for Indian pharmaceuticals and medical devices. Their mission is to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. It is CDSCO's responsibility to regulate medical devices under its Medical Devices Rules, 2017.

How to manufacture The Endoscopic Needleless Submucosal Lift Catheter

In order to manufacture an Endoscopic Needleless Submucosal Lift Catheter, it is necessary to have a comprehensive understanding of the design and material requirements for the device. Details like accurate dimensions, optimal material choice, and rigorous quality checks are important to ensure a product that meets international standards.

Fees for a manufacturing license for Endoscopic Needleless Submucosal Lift Catheter

The Endoscopic Needleless Submucosal Lift Catheter falls under the Class B risk category. As per the CDSCO norms, the manufacturing of Class B devices requires an MD5 license. The fees involved are Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for The Endoscopic Needleless Submucosal Lift Catheter?

Acquiring a manufacturing license is mandatory for producing Class B medical devices like the Endoscopic Needleless Submucosal Lift Catheter. The license acts as a guarantee of the manufacturer's adherence to quality standards and safety guidelines laid down by the CDSCO. In a sector as sensitive as healthcare, regulatory compliance is indispensable for ensuring patient safety and high-quality healthcare services.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Needleless Submucosal Lift Catheter

  1. Gathering and preparing all the required documentation, including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. The manufacturing license application must be correctly filled and submitted.
  3. Ensuring the proper follow-up of the submitted application.
  4. Overcoming any challenges that arise during the application review process.

Frequently Asked Questions (FAQs)

  1. What is the risk class of the Endoscopic Needleless Submucosal Lift Catheter as per Medical Device Rules, 2017?
    • The Endoscopic Needleless Submucosal Lift Catheter falls under the Class B risk category.
  2. What license is needed to manufacture the Endoscopic Needleless Submucosal Lift Catheter?
    • The manufacturing of Class B devices like the Endoscopic Needleless Submucosal Lift Catheter requires an MD5 license.
  3. What are the fees for an MD5 license for the Endoscopic Needleless Submucosal Lift Catheter?
    • The fees involved are Rs. 5,000 for the license and Rs. 500 per product.
  4. Who will issue the manufacturing license for the Endoscopic Needleless Submucosal Lift Catheter?
    • For Class B devices such as the Endoscopic Needleless Submucosal Lift Catheter, the state FDA will issue the license.
  5. Is repackaging of the Endoscopic Needleless Submucosal Lift Catheter considered manufacturing?
    • 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 the Endoscopic Needleless Submucosal Lift Catheter is also considered manufacturing requiring an MD5 license.

Conclusion

Understanding the CDSCO's regulations for medical devices can be complicated. At Pharmadocx Consultants, we offer consultation and guidance to help navigate this process. If you would like to learn more about the process of obtaining an MD5 license for manufacturing class B medical devices like the Endoscopic Needleless Submucosal Lift Catheter, please read our detailed article here.

Please feel free to reach out to us for consultation or assistance regarding the licensing process. Contact us here or call us at +91-7404557227 or email us at [email protected]. We are here to assist you every step of the way!

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