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CDSCO Manufacturing License for Endoscopic spray catheter

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Introduction

The Central Drugs Standard Control Organization, commonly termed CDSCO, is India’s primary national regulatory body for pharmaceuticals and medical devices. This organization is the core regulatory authority monitoring the safety, effectiveness, and quality of medical products manufactured, imported, or distributed in India. Within the thriving medical device industry, obtaining the requisite manufacturing licenses is a paramount step, ensuring that companies adhere to stringent quality standards set forth by the CDSCO.

In this context, we take a close look at the Endoscopic Spray Catheter, an essential medical device used extensively within gastroenterology. This essential piece of medical equipment plays a crucial role in administering fluids in a spray form during endoscopy, which is a crucial procedure within gastroenterology.

For more information about CDSCO and the crucial role it plays in regulating medical devices in India, visit the organization's official portal at - CDSCO.

What is an Endoscopic Spray Catheter?

The Endoscopic Spray Catheter is a flexible, sterile tube intended for use with an endoscope, primarily colonoscope, to administer fluids, such as dyes for mucosal coloration in a spray form. It is a crucial medical device in the field of gastroenterology, allowing medical practitioners to perform endoscopic procedures efficiently and effectively.

The Role of CDSCO in Medical Device Regulation

Since its initiation, the CDSCO has been committed to safeguarding public health in India by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. Within its broad regulatory framework, the CDSCO has a set, extensive process that includes the classification of medical devices, licensing, surveillance, and other regulatory activities indispensable to managing the quality of medical devices in India.

How to Manufacture an Endoscopic Spray Catheter

The manufacture of an Endoscopic Spray Catheter must comply with the regulations and guidelines set forth by the CDSCO and Medial Device Rules 2017. For a class B medical device like the Endoscopic Spray Catheter, the MD5 license is needed.

Fees for Manufacturing License for Endoscopic Spray Catheter

For a class B device like the Endoscopic Spray Catheter, the required license - MD5 calls for a fee of Rs. 5,000 and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Endoscopic Spray Catheter?

The acquisition of a manufacturing license, such as MD5, is essential for class B medical devices, including the Endoscopic Spray Catheter. This requirement guarantees adherence to the strict quality and safety standards set by the regulatory body, thereby safeguarding the healthcare sector from substandard products while ensuring regulatory compliance.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Spray Catheter

To obtain the necessary manufacturing license from the CDSCO, the following prerequisites and documentation are required notably, Device Master File, Quality Management Certificate, Device Details, Site details, and more. The application process involves submission, scrutiny, and eventually, approval. However, this process may encounter several challenges, the solutions to which can be found at our consultant site, Pharmadocx Consultants.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Endoscopic Spray Catheter as per the Medical Device Rules, 2017?

The Endoscopic Spray Catheter is classified as a Class B medical device.

Q2. What license is needed to manufacture an Endoscopic Spray Catheter?

A MD5 license is needed for manufacturing an Endoscopic Spray Catheter.

Q3. What is the fee for an MD5 license for the Endoscopic Spray Catheter?

The fee for an MD5 license is Rs. 5,000, plus an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for the Endoscopic Spray Catheter?

The state FDA is responsible for issuing the MD5 license for class B devices like the Endoscopic Spray Catheter.

Q5. Is the repackaging of an Endoscopic Spray Catheter considered manufacturing?

Yes, as per the Drug and Cosmetics Act's definition of manufacturing that includes the repackaging of drugs. By this definition, medical devices such as the Endoscopic Spray Catheter are also considered drugs and their repackaging requires an MD5 license.

Conclusion

Pharmadocx Consultants offers expert guidance to those seeking assistance concerning the CDSCO license process. With well-qualified consultants, they provide consultations and assistance relating to the license process. To reach for consultation, please visit https://www.pharmadocx.com, call at "+91-7404557227", or send an email to "[email protected]". Use this link for articles related to acquiring MD5 licenses for class A and B medical devices.

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