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CDSCO Manufacturing License for Catheter-balloon inflator, reusable

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Introduction

The Central Drugs Standard Control Organization, also known as CDSCO is the national regulatory authority of India that is responsible for license approval for manufacturing of new medical devices and the regulation of these devices. Ensuring safety and effectiveness, and sustaining the quality of medical devices manufactured in India is of pivotal importance for this organization.

In the ever-evolving medical industry, manufacturing licences play a crucial role in supply chain management and quality control. Manufacturing licenses ensure that medical devices adhere to necessary safety standards and guidelines, therefore ensuring the manufacturing of safe and reliable medical devices.

One such medical device that holds substantial importance in medical procedures involving the intestines, stomach, and other parts of the gastrointestinal system is the Catheter-balloon inflator, reusable. In this blog post, we will be discussing various aspects related to the manufacturing, intended use, and the licensing process of this medical device.

Here is the link to CDSCO's official portal CDSCO

What is Catheter-balloon inflator, reusable?

A Catheter-balloon inflator, reusable is a medical device designed for the purpose of manually inflating and regulating the pressure of a balloon catheter. This is achieved by injecting and aspirating fluid or air within the balloon. Moreover, this device is also used to deflate the balloon during a medical procedure.

Commonly used in procedures such as angioplasty and stent placement, this device plays an integral role in treating various cardiac and gastrointestinal disorders.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) is a long-standing pillar of medical device regulations in India. Established under the provisions of Drugs and Cosmetics Act, it serves the purpose of standardizing and controlling the production and availability of drugs and medical devices in India.

CDSCO's regulatory framework for medical devices is designed to ensure that medical devices meet standardized safety measures and guidelines before they are released into the market.

How to manufacture Catheter-balloon inflator, Reusable

Manufacturing of a Catheter-balloon inflator, reusable requires adherence to strict quality standards and norms which are dictated by medical regulatory authorities such as CDSCO. Furthermore, the manufacturer must possess a valid manufacturing license.

Fees for the manufacturing license for Catheter-balloon inflator, reusable

For Risk Class B medical devices like the Catheter-balloon inflator, reusable, an MD5 license is required. The license fee for an MD5 license is set at Rs. 5,000 and an additional product fee of Rs. 500 per product is charged.

Why is a Manufacturing License Necessary for Catheter-balloon inflator, Reusable?

A manufacturing license is mandatory for medical devices manufacturing as it ensures the quality and safety in the production process. This plays a significant role in safeguarding consumers and patients from substandard products, proving the regulatory compliance in the healthcare sector is of massive importance.

Steps to Obtain a CDSCO Manufacturing License for Catheter-balloon inflator, reusable

Here we have broadly simplified the steps to acquire the requisite license.

  • Preparatory requisites: Possess necessary documents like Device Master File, Quality Management Certificate, Device Details, Site details etc.
  • Application Process: Complete the application and submit it to the relevant authority.
  • Verification Process: Wait for your application's processing and approval

Further details can be found in this article MD 5 License.

Frequently Asked Questions (FAQs)

  1. What is risk class of Catheter-balloon inflator, reusable as per Medical Device Rules, 2017? Risk class of Catheter-balloon inflator, reusable is Class B.

  2. What license is needed to manufacture Catheter-balloon inflator, reusable? MD5 license is required to manufacture Catheter-balloon inflator, reusable.

  3. What is the fee for MD5 license for Catheter-balloon inflator, reusable? The fee for the MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

  4. Who will issue manufacturing license for Catheter-balloon inflator, reusable? The state FDA will issue the license for Class B devices like Catheter-balloon inflator, reusable.

  5. Is repackaging of Catheter-balloon inflator, reusable considered manufacturing? Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Catheter-balloon inflator, reusable is also considered manufacturing and requires an MD5 license.

Conclusion

The manufacturing of medical devices like Catheter-balloon inflator, reusable, involves intricate procedures and regulations. Compliance with these guidelines is not just for legal adherence, but it is also a means to ensure the safety and well-being of the users of these medical devices.

If you're in need of assistance regarding the application or understanding of the licensing process for medical devices, feel free to reach out for consultation to our experienced team at Pharmadoxc Consultants, or call us on "+91-7404557227" or drop us an email at "[email protected]".

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