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CDSCO Manufacturing License for Flexible video duodenoscope, reusable

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. With many medical gadgets playing an essential part in the healthcare sector, the importance of obtaining manufacturing licenses should not be underestimated.

In this write-up, we'll put a focus on a crucial medical device known as the Flexible Video Duodenoscope, reusable. With its central role in visual examination and treatment of the duodenum, it is of great significance in the field of gastroenterology. For additional information, the CDSCO's dedicated portal can be accessed through the link - (https://cdscomdonline.gov.in/NewMedDev/Homepage).

What is Flexible Video Duodenoscope, reusable?

Being a type of endoscope, the Flexible Video Duodenoscope, reusable is intended for the visual examination and treatment of the duodenum. Its ability to be flexibly inserted makes it a significant device in gastroenterology. It is commonly used in procedures like ERCP (Endoscopic Retrograde Cholangiopancreatography) to diagnose and treat diseases within the bile or pancreatic ducts.

The Role of CDSCO in Medical Device Regulation

The CDSCO's mission is to safeguard and enhance the public health by ensuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Under the CDSCO's regulatory framework, medical devices like the Flexible Video Duodenoscope, reusable, fall under risk class B.

How to manufacture Flexible Video Duodenoscope, reusable

Considering it belongs to class B, the required license to manufacture Flexible Video Duodenoscope, reusable is MD5.

Fees for manufacturing license for Flexible Video Duodenoscope, reusable

To obtain the MD5 license, an amount of Rs. 5,000 is to be paid as license fee and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Flexible Video Duodenoscope, reusable?

Being legally mandatory, a manufacturing license ensures quality and safety in the production of medical devices. It stands as a testament to the regulatory compliance in the healthcare sector while protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Flexible Video Duodenoscope, reusable

  1. Completing pre-requisites including Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submission of the application along with supporting documents.
  3. Review and evaluation of the submitted application.
  4. Approval of the application and issuance of the required license.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Flexible Video Duodenoscope, reusable as per Medical Device Rules, 2017? A. The Flexible Video Duodenoscope, reusable falls under risk class B.

Q. What license in needed to manufacture Flexible Video Duodenoscope, reusable? A. The MD5 license is needed to manufacture Flexible Video Duodenoscope, reusable.

Q. What is the fees for MD5 license for Flexible Video Duodenoscope, reusable? A. The fees for obtaining the MD5 license is Rs. 5,000 and an additional fee of Rs. 500 per product.

Q. Who will issue manufacturing license for Flexible Video Duodenoscope, reusable? A. For class B devices like the Flexible Video Duodenoscope, reusable, the state FDA will issue the license.

Q. Is repackaging of Flexible Video Duodenoscope, reusable considered manufacturing? A. Yes, per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is considered as manufacturing. Hence repackaging of Flexible Video Duodenoscope, reusable also requires a license, which in this case would be MD5.

Conclusion

Obtaining a CDSCO manufacturing license might seem tricky at first, but with the proper guidance and support, it can be an achievable task. For expert consultation or assistance regarding the licensing process, feel free to reach out to Pharmadocx Consultants on +91-7404557227, or drop an email at [email protected]. For more details on MD5 license, refer to this article.

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