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CDSCO Manufacturing License for Flexible video gastroscope

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Introduction

The Central Drugs Standard Control Organization (CDSCO), the principal regulatory body in India overseeing the safety, efficacy, and quality of medical devices, understandably requires medical device manufacturers to acquire specific licenses based on the risk level associated with the device. Medical devices span an enormous range, from simple devices like bandages to complex devices like pacemakers, and the requirement for a manufacturing license ensures the safety and efficacy of these devices.

In this light, we introduce the Flexible Video Gastroscope, a pivotal tool in gastroenterology. Pioneering advancements in internal medicine, gastroscopies enable doctors to visually examine a patient's gastrointestinal tract and make crucial diagnoses.

For more information on the CDSCO and medical devices, visit CDSCO's portal

What is a Flexible Video Gastroscope?

A Flexible Video Gastroscope is an essential medical device used in the field of gastroenterology. Boasting a flexible insert portion, the device is designed for visual examination and treatment of the oesophagus and stomach. A doctor performs a gastroscopy by inserting the gastroscope through the patient's mouth and down the oesophagus into the stomach. The flexible body of the gastroscope allows for convenient navigation through the twisted structure of the upper gastrointestinal tract, resulting in highly effective diagnostics and treatments.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been the principal regulatory body governing the safety, quality, and distribution of medical devices and drugs in India. One of CDSCO's pivotal roles is the regulation of medical devices, where it categorises devices into four classes - A, B, C, D based on the risk associated. CDSCO's regulatory framework for medical devices ensures only safe, effective, and quality devices reach patients.

How to Manufacture a Flexible Video Gastroscope

The manufacturing of a Flexible Video Gastroscope involves intricate processes conforming to stringent regulations set by the CDSCO. Ensure your facility is equipped with the latest technology and follows the best manufacturing practices.

Fees for Manufacturing License for a Flexible Video Gastroscope

As a Class B device, the manufacturing license required for a Flexible Video Gastroscope is MD5. The license fee for MD5 is Rs. 5,000 along with a product fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for a Flexible Video Gastroscope?

Maintaining a CDSCO-approved license is mandatory, not optional, for manufacturing medical devices. This license ensures the manufacturer meets the quality and safety standards set by the CDSCO, consequently protecting consumers and patients from low-quality or dangerous products. Further, adherence to these regulations fosters trust in the healthcare sector and underscores the value of regulatory compliance.

Steps to Procure a CDSCO Manufacturing License for a Flexible Video Gastroscope

Here are simplified steps to procure the license -

  1. Prepare the necessary documents, including Device Master File, Quality Management Certificate, Device Details, and Site Details, among others.
  2. Submit the application with supporting documents.
  3. Navigating the review and approval stages by the CDSCO officials.
  4. Overcoming common challenges such as documentation errors by being meticulous and thorough in application preparation.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Flexible Video Gastroscope as per Medical Device Rules, 2017?

Answer - Flexible Video Gastroscope is classified as a Class B device.

Q2. What license is needed to manufacture a Flexible Video Gastroscope?

Answer - An MD5 license is required to manufacture a Flexible Video Gastroscope.

Q3. What is the fee for an MD5 license for a Flexible Video Gastroscope?

Answer - The license fee for MD5 is Rs. 5,000, and the product fee is Rs. 500 per product.

Q4. Who will issue a manufacturing license for a Flexible Video Gastroscope?

Answer - For a Class B device like a Flexible Video Gastroscope, the state FDA will issue the license.

Q5. Is repackaging of a Flexible Video Gastroscope considered manufacturing?

Answer - Yes, as per the Drugs and Cosmetics Act's definition, repackaging of drugs and by extension, medical devices, is considered manufacturing. Thus, repackaging a Flexible Video Gastroscope requires an MD5 license.

Conclusion

Complying with all CDSCO license requirements can be daunting and time-consuming. However, rest assured that Pharmadocx Consultants can provide expert assistance in obtaining the required licenses or any other regulatory consultation. Visit Pharmadocx's website for more information. One can also call us directly at +91-7404557227 or drop an email at [email protected]. To learn in more detail about the MD5 license required for class A and B devices, visit this link here.

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