Published on

CDSCO Manufacturing License for Flexible video oesophagoscope, single- use

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the Indian medical device industry by safeguarding public health and ensuring safety. The organization is entrusted with the responsibility of approving licenses to manufacture and distribute medical devices in the country. In this article, we will extensively discuss the CDSCO manufacturing license for a very important device in gastroenterology - the Flexible video oesophagoscope. With medical technology constantly evolving, this device marks a significant milestone in diagnosing and treating diseases related to the oesophagus in a less invasive way. Understand more about the device and its manufacturing regulation on CDSCO's portal.

What is a Flexible Video Oesophagoscope?

A Flexible video oesophagoscope is an advanced medical instrument mainly used in gastroenterology, an area of medicine focused on the digestive system and its disorders. This endoscope comes with a flexible inserted portion designed for the visual examination and treatment of the oesophagus. It allows doctors to see the inside of the oesophagus and thus diagnosing or treat potential problems.

The Role of CDSCO in Medical Device Regulations

CDSCO serves as the national regulatory body for Indian pharmaceuticals and medical devices. CDSCO is indispensable in establishing standards and regulatory measures for the safe and effective production of medical devices. The medical device regulations are based on a risk-based approach, categorizing devices into four classes - A,B, C, D. The Flexible video oesophagoscope falls under Class B.

How to Manufacture a Flexible Video Oesophagoscope

Manufacturing a Flexible Video Oesophagoscope requires appropriate regulatory approval and licensing governed by CDSCO. It should abide by the regulations concerning manufacturing conditions, safety, efficacy, and quality of the device.

Fees for Manufacturing License for Flexible Video Oesophagoscope

Given the Flexible video oesophagoscope falls under the Class B category, the necessary license required is MD5. The fees for MD5 is Rs. 5,000 for the license and Rs. 500 per product, as per CDSCO guidelines.

Why is Manufacturing License Necessary for Flexible Video Oesophagoscope?

Acquiring a manufacturing license is mandatory and for good reasons. It ensures quality, safety, and compliance in the production of medical devices. It also protects the patients and consumers from substandard, and potentially dangerous devices. Furthermore, it signifies that the device holds up to the medical standards as per the regulatory authorities.

Steps to Obtain a CDSCO Manufacturing License for Flexible Video Oesophagoscope

Obtaining a manufacturing license from CDSCO involves several stags which include preparing necessary documentation such as Device Master File, Quality Management Certificate, Device Details, Site details, etc., and going through the application process from submission to approval. Following this, there may be challenges that arise and understanding ways to overcome them is critical.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Flexible Video Oesophagoscope as per Medical Device Rules, 2017? A. The Flexible Video Oesophagoscope falls under Risk Class B.

Q2. What license is needed to manufacture Flexible Video Oesophagoscope? A. To manufacture Flexible Video Oesophagoscope, an MD5 license is needed.

Q3. What is the fees for MD5 license for Flexible Video Oesophagoscope? A. The license fee for MD5 is Rs. 5,000 and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Flexible Video Oesophagoscope? A. For Class B devices like Flexible Video Oesophagoscope, the state FDA will issue the license.

Q5. Is repackaging of Flexible Video Oesophagoscope considered manufacturing? A. Yes, under Drugs and Cosmetics Act's definition, repackaging of drugs and hence medical devices like Flexible Video Oesophagoscope is considered manufacturing. A license on MD5 is required for it.

Conclusion

The regulatory process may seem overwhelming but it is crucial in maintaining the quality of medical devices. For expert consultation or for assistance in acquiring CDSCO manufacturing license, you may consider reaching out to Pharmadocx Consultants or call directly on "+91-7404557227" or drop an email to "[email protected]". For more detailed information about the MD5 license, follow this link. Fight your way through the bureaucracy and regulations with experienced guidance to reach your manufacturing goals successfully.

cdsco import license in india banner
cdsco manufacturing license in india banner