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CDSCO Manufacturing License for Epistaxis balloon

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's topmost governing body for the regulation and approval of drugs and medical devices. With a vision to safeguard public health, CDSCO holds the crucial responsibility to certify the safety, efficacy, and quality of the medical products circulated in the market. With an extensive reach over diverse healthcare sectors, one of its crucial concerns is the regulation and licensing of medical devices manufacturing, to ensure their compliance with the laid standards and protocols.

In the world of medicine, the significance of medical devices is unparalleled. Among these devices, one such innovative instrument is the Epistaxis balloon, an essential addition to medical facilities dealing with ENT disorders. As a life-saving device, the Epistaxis balloon marks its importance in managing nose bleeds, a condition often challenging to manage.

Kindly visit CDSCO's portal to get more information about these regulations and many more.

What is an Epistaxis Balloon?

The Epistaxis balloon is a medical device specifically designed to control internal nasal bleeding by applying adequate pressure against the sphenopalatine artery. It's a major breakthrough in the field of medicine, particularly the ENT specialty, for its effectiveness in managing epistaxis or nose bleeding.

The Epistaxis balloon is usually used in managing severe and recurrent cases of nose bleeding, where conventional measures are inadequate. It offers a minimally invasive technique, meaning fewer complications and shorter hospital stays.

The Role of CDSCO in Medical Device Regulation

The CDSCO has established itself as a potent body that ensures the delivery of safe, effective, and quality medical products in India. With a robust regulatory framework, it smoothly governs the manufacture, sale, and distribution of medical devices.

CDSCO's primary tasks involve setting standards, approving licenses, conducting clinical trials supervision, import control, coordination with state regulators, and more. It manages the Medical Device Rules of 2017, under which medical devices are categorized into Class A, B, C, and D based on their potential risks and complexities associated with them.

How to Manufacture an Epistaxis Balloon

The manufacturing of an Epistaxis balloon involves complying with the regulations set by the CDSCO. The first step is understanding the risk class for the device, which forms the base for the type of manufacturing license required.

In the case of the Epistaxis balloon, it's categorized under Class B, a low to moderate risk device. Therefore, as per the CDSCO's regulatory guidance, the license required for manufacturing an Epistaxis balloon is an MD5 license.

Fees for Manufacturing License for an Epistaxis Balloon

As per the CDSCO's fee structure, an MD5 license for the manufacturing of Class B devices costs Rs. 5,000 along with an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for an Epistaxis Balloon?

A manufacturing license embodies a mark of assurance on the product in terms of its safety, quality, and effectiveness. It's a mandatory requirement as per the laws, but it serves the rather noble purpose of safeguarding public health.

This mandate ensures that every Epistaxis balloon produced in the market complies with the necessary standards, truncate the circulation of substandard products, and ultimately protecting the consumers - the patients in this case. Regulatory compliance sets the ground for high-quality healthcare deliverance.

Steps to Obtain a CDSCO Manufacturing License for an Epistaxis Balloon

The process of obtaining a manufacturing license for an Epistaxis balloon through CDSCO involves a few necessary steps -

  1. Preparation of required documents including the Device Master File, Quality Management Certificate, Device Details, and Site Details.
  2. Submission of the documents along with the application form.
  3. Approval from the CDSCO after thorough examination.
  4. Overcoming any challenges likely to be faced during the process with expert guidance.

Learn more about the licensing process and compliance requirements at MD5 License procedure.

Frequently Asked Questions (FAQs)

1. Q: What is risk class of Epistaxis Balloon as per Medical Device Rules, 2017?

A: The Epistaxis Balloon is categorized under Risk Class B as per the Medical Device Rules, 2017.

2. Q: What license is needed to manufacture Epistaxis Balloon?

A: An MD5 license is required to manufacture an Epistaxis Balloon.

3. Q: What is fees for MD5 license for Epistaxis Balloon?

A: The fee for an MD5 license for an Epistaxis Balloon is Rs. 5,000 for the license and an additional Rs. 500 per product.

4. Q: Who will issue manufacturing license for Epistaxis Balloon?

A: For Class B devices like Epistaxis Balloon, the state FDA will issue the license.

5. Q: Is repackaging of Epistaxis Balloon considered manufacturing?

A: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and medical devices, including the Epistaxis Balloon is considered manufacturing requiring an MD5 license.

Conclusion

Navigating through the intricate milieu of medical device regulations can be a daunting task. But worry not! With experts like us at your service, you can ensure a smooth, hassle-free journey from application to approval. Feel free to reach out for consultation or assistance regarding the licensing process to Pharmadocx Consultants, or call us directly at +91-7404557227, or drop us an email at [email protected]. We are just a click away!

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