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CDSCO Manufacturing License for Catheter-balloon inflator, reprocessed

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CDSCO Manufacturing License for Catheter-balloon inflator, reprocessed

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body for pharmaceuticals and medical devices in India. The organization plays an essential role in ensuring the safety, efficacy, and quality of medical devices manufactured and imported in the country. Manufacturing licenses in the medical device industry are key for producers to legally operate and market their products.

The device in focus here is a Catheter-balloon inflator, reprocessed. This device is of great important in the medical industry. Potential manufacturers can secure an understanding of the device's significance and the licensing fees by visiting CDSCO's portal here.

What is Catheter-balloon inflator, reprocessed?

A Catheter-balloon inflator, reprocessed, is a device designed to inflate and control the pressure of a balloon catheter manually. This device aids medical procedures by injecting and aspirating fluid or air within the balloon, and also deflating the balloon when necessary. It's commonly used during angiography, angioplasty, gastrointestinal (GI), or sinuplasty procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO, established over 50 years ago, looks to protect and promote public health in India by overseeing the quality of drugs, cosmetics and medical devices, including devices like the Catheter-balloon inflator. Their regulatory framework for medical devices covers the device's entire lifecycle, from the approval and production stage to post-market surveillance.

How to manufacture Catheter-balloon inflator, reprocessed

Fees for manufacturing license for Catheter-balloon inflator, reprocessed

Catheter-balloon inflator, reprocessed falls under Risk Class B and requires an MD5 license. The fee for obtaining the MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

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

Manufacturing licenses are mandatory to ensure quality and safety in the medical device production process. Regulatory compliance in the healthcare sector is of utmost importance, protecting consumers and patients from substandard and potentially harmful products.

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

For the manufacturing license, it is necessary to have a Device Master File, Quality Management Certificate, Device Details, Site details etc. The application process includes the submission of appropriately filled forms and requisite documentation, with approval often requiring adherence to certain specifications and inspections.

FAQs

Q1. What is the risk class of Catheter-balloon inflator, reprocessed as per Medical Device Rules, 2017? The Catheter-balloon inflator, reprocessed, falls under Risk Class B.

Q2. What license in needed to manufacture Catheter-balloon inflator, reprocessed? An MD5 license is needed to manufacture Catheter-balloon inflator, reprocessed.

Q3. What is the fees for MD5 license for Catheter-balloon inflator, reprocessed? The fee for an MD5 license is Rs. 5,000, with an additional fee of Rs. 500 per product.

Q4. Who will issue the manufacturing license for Catheter-balloon inflator, reprocessed? For Class B devices, like Catheter-balloon inflator, reprocessed, the state FDA will issue the license.

Q5. Is repackaging of Catheter-balloon inflator, reprocessed considered manufacturing? Yes, by definition under the Drugs and Cosmetics Act, repackaging of drugs and by extension, medical devices, is considered manufacturing. As such, repackaging the Catheter-balloon inflator, reprocessed, would also require an MD5 license.

Conclusion

Navigating the licensing process can be complex but it's a crucial step in ensuring regulatory compliance and protecting public health. For those looking for assistance or consultation on obtaining a CDSCO manufacturing license, feel free to reach out to the experts at Pharmadocx Consultants, call +91-7404557227, or email [email protected]. For more detailed information on obtaining an MD5 license, refer to this article.

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