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CDSCO Manufacturing License for Gastrointestinal catheter/endoscope tracking system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a vital role in safeguarding the public health in India. In the arena of medical devices, the importance of licenses can't be overstated. These licenses ensure medical practitioners and patients across the nation have access to safe and effective medical devices.

In our focused discourse today, we dive into the realm of Gastrointestinal catheter/endoscope tracking systems. These intricate pieces of technology are crucial for diagnosis and treatment procedures in the field of Gastroenterology.

CDSCO's official portal provides a wealth of information on the manufacturing licenses and procedures related to these devices. For quick access, click here.

What is a Gastrointestinal catheter/endoscope tracking system?

A Gastrointestinal catheter/endoscope tracking system is a multi-component assembly of AC-powered devices used in gastroenterology for real-time visualization/navigation of a catheter and/or endoscope. It creates an electromagnetic (EM) field to detect the position and movement of the catheter or endoscope and provides a three-dimensional (3-D) virtual image display through a monitoring screen.

The Role of CDSCO in Medical Device Regulation

With a rich history of safeguarding public health, CDSCO’s mission focuses on providing and maintaining international standards of quality in drugs, cosmetics and medical devices. The organization follows an intricate regulatory framework for medical devices, which includes risk-based classification, clinical trials, conformity assessments, licenses, and post-marketing surveillance.

How to manufacture a Gastrointestinal catheter/endoscope tracking system

Medical devices, especially those of Class B, such as the Gastrointestinal catheter/endoscope tracking system, must undergo an intensive manufacturing process that must adhere to the stringent guidelines and regulations outlined by CDSCO.

Fees for manufacturing license for Gastrointestinal catheter/endoscope tracking system

The Gastrointestinal catheter/endoscope tracking system falls under the Risk Class B. To manufacture it, an MD5 license is required. As per the CDSCO fee structure, the license costs Rs. 5,000 and an additional fee of Rs. 500 is levied per product.

Why is a Manufacturing License Necessary for a Gastrointestinal catheter/endoscope tracking system?

Regulation is paramount in the world of healthcare, and medical devices are no exception. A manufacturing license is not only mandatory but also instrumental in maintaining the quality and safety of these intricate devices. A license ensures regulatory compliance, protecting patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Gastrointestinal catheter/endoscope tracking system

  1. Prerequisites and Documentation: Important documents such as Device Master File, Quality Management Certificate, Device Details, Site details are required.
  2. Submission of Application: The application must be submitted to CDSCO through their official portal.
  3. Review and Approval: After a thorough examination, if your application meets all the necessary guidelines and regulations, it is approved.
  4. Issuance of License: Post approval, the manufacturing license is issued.

Frequently Asked Questions (FAQs)

Q: What is the risk class of a Gastrointestinal catheter/endoscope tracking system as per Medical Device Rules, 2017? A: The Gastrointestinal catheter/endoscope tracking system falls under Risk Class B.

Q: What license is needed to manufacture a Gastrointestinal catheter/endoscope tracking system? A: An MD5 license is required to manufacture a Gastrointestinal catheter/endoscope tracking system.

Q: What is the fees for an MD5 license for a Gastrointestinal catheter/endoscope tracking system? A: The fees is Rs. 5,000 for the license and an additional Rs. 500 is charged per product.

Q: Who will issue the manufacturing license for a Gastrointestinal catheter/endoscope tracking system? A: The state FDA will issue the license for a Class B medical device such as a Gastrointestinal catheter/endoscope tracking system.

Q: Is repackaging of a Gastrointestinal catheter/endoscope tracking system considered manufacturing? A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of the Drug Act only and hence repackaging of a Gastrointestinal catheter/endoscope tracking system is also considered manufacturing requiring an MD5 license.

Conclusion

Embarking on the journey of manufacturing a medical device requires thorough understanding of regulations and guidance. For any inquiries or consultation on the licensing process, reach out to the team of experts at Pharmadocx Consultants. Feel free to give us a call at +91-7404557227 or send an email to [email protected] for immediate assistance. For detailed information on MD5 license, check out this article.

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