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CDSCO Manufacturing License for Endoscopic electrosurgical electrode/submucosal lift needle

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Introduction

CDSCO, also known as the Central Drugs Standard Control Organization, plays an integral role in managing the use and production of medical devices in India. Navigating the complexities and mandatory requirements is not an easy task, which is why obtaining a manufacturing license becomes a crucial step in the medical device industry. One such device that requires a manufacturing license is the Endoscopic Electrosurgical Electrode/Submucosal Lift Needle.

This blog post aims to provide a comprehensive understanding of this specific medical device, its significance in the medical field and the regulatory requirements involved in its production. More information about it can be obtained from CDSCO's portal here

What is an Endoscopic Electrosurgical Electrode/Submucosal Lift Needle?

The Endoscopic Electrosurgical Electrode/Submucosal Lift Needle is a sterile, invasive, endoscopic device created with a dual purpose; to deliver a submucosal lifting solution as well as an electrosurgical current in a monopolar configuration to tissues for cutting/coagulation. This device's primary use falls under the bracket of Gastroenterology and is classified as a Risk Class B.

The Role of CDSCO in Medical Device Regulation

CDSCO's history of medical device regulation dates back years, with them being responsible for the establishment of quality standards, safety monitoring and regulatory approval.

How to manufacture an Endoscopic Electrosurgical Electrode/Submucosal Lift Needle?

To manufacture this device in India, one must first obtain manufacturing license from the regulatory authority. The license necessary for a Class B medical device is MD5.

Fees for manufacturing license for Endoscopic Electrosurgical Electrode/Submucosal Lift Needle

The fees for obtaining an MD5 license is Rs. 5000, and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Endoscopic Electrosurgical Electrode/Submucosal Lift Needle?

It is mandatory for manufacturers to obtain a license as it ensures the product’s quality and safety. Acquiring this license is an essential step in ensuring regulatory compliance in the healthcare sector. It primarily exists to protect consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Electrosurgical Electrode/Submucosal Lift Needle

  1. Assemble the necessary documents including the Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submit the application to the relevant regulatory body.
  3. Await the approval.
  4. After the approval, you can start manufacturing.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Endoscopic Electrosurgical Electrode/Submucosal Lift Needle as per Medical Device Rules, 2017? A. The Risk Class for this device is Class B.

  2. What license is needed to manufacture Endoscopic Electrosurgical Electrode/Submucosal Lift Needle? A. The required license is MD5.

  3. What is the fees for MD5 license for Endoscopic Electrosurgical Electrode/Submucosal Lift Needle? A. The fee for the MD5 license is Rs. 5000 for license and Rs. 500 per product.

  4. Who will issue a manufacturing license for Endoscopic Electrosurgical Electrode/Submucosal Lift Needle? A. For class B devices, state FDA will issue the license.

  5. Is repackaging of Endoscopic Electrosurgical Electrode/Submucosal Lift Needle 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 Endoscopic Electrosurgical Electrode/Submucosal Lift Needle is also considered manufacturing requiring a license on MD5.

Conclusion

Our firm, Pharmadocx Consultants, are experts at guiding you through this process. If you require further consultation on obtaining a license or need assistance in the process, we are there to help you. Reach out to us at "+91-7404557227" or email us at "[email protected]". Additionally, to get precise details of the license procedure and documents required for MD5 license, please go to this article.

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