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CDSCO Manufacturing License for Disposable Hemoperfusion Cartridge

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in ensuring the nation's health and wellness. It remains at the core of defining and regulating standards in the realms of drugs, medical devices, and cosmetics. One of the critical aspects central to CDSCO's functions is the issuance of manufacturing licenses for medical devices.

This license assures that the manufacturing of medical devices aligns with the standard and safety guidelines. Therefore, obtaining a manufacturing license is an indispensable step in the cycle of medical device production.

This post will delve deep into the manufacturing license processes required for a unique medical device known as the Disposable Hemoperfusion Cartridge. This life-saving device has significantly impacted the arena of Nephrology and renal care.

For more information, the CDSCO's portal provides a detailed guide https://cdscomdonline.gov.in/NewMedDev/Homepage.

What is a Disposable Hemoperfusion Cartridge?

A Disposable Hemoperfusion Cartridge is a specialized device designed for use in hemoperfusion machines. It is designed to selectively remove specific toxins or drugs from the blood by means of extracorporeal circulation. This device is integral in the treatment of severe drug overdoses or poisoning.

The Role of CDSCO in Medical Device Regulation

CDSCO lies at the heart of overseeing the safety, efficacy, and quality of medical devices in India. It ensures that factors such as the clinical efficacy, safety, performance, quality, and labeling of medical devices align with the stipulated norms.

How to manufacture a Disposable Hemoperfusion Cartridge

Manufacturing a Disposable Hemoperfusion Cartridge is a complex and critical process. It requires compliance with good manufacturing practices and safety guidelines to ensure the production of a high-quality device that adheres to regulatory norms.

Fees for Manufacturing License for Disposable Hemoperfusion Cartridge

To manufacture a Disposable Hemoperfusion Cartridge, which is classified as a class C medical device, an MD9 license is required. The fees for obtaining an MD9 license are Rs. 50,000 along with an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Disposable Hemoperfusion Cartridge?

Obtaining a manufacturing license is a statutory mandate for the production of any medical device. The license not only validates the manufacturing process, but also ensures that the device complies with the quality and safety regulations. Furthermore, the license protects consumers and patients, ensuring that they receive products of the best standards.

Steps to Obtain a CDSCO Manufacturing License for Disposable Hemoperfusion Cartridge

The process to obtaining a license involves a few steps:

  1. Submission of required documents like Device Master File, Quality Management Certificate, Device Details, Site details, etc.,
  2. Review and verification of these documents,
  3. Inspection of the manufacturing site,
  4. Issue of license after satisfactory completion of all the above steps.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Disposable Hemoperfusion Cartridge as per Medical Device Rules, 2017?

Disposable Hemoperfusion Cartridge is classified as a Class C medical device.

Q2. What license is needed to manufacture a Disposable Hemoperfusion Cartridge?

The required license to manufacture a Disposable Hemoperfusion Cartridge is MD9.

Q3. What is the fee for an MD9 license for the Disposable Hemoperfusion Cartridge?

The fee for an MD9 license is Rs. 50,000, along with an additional Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Disposable Hemoperfusion Cartridge?

The CDSCO HQ in New Delhi will issue the manufacturing license for Class C & D devices, including the Disposable Hemoperfusion Cartridge.

Q5. Is repackaging of Disposable Hemoperfusion Cartridge considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and medical devices is considered manufacturing. Therefore, repackaging of a Disposable Hemoperfusion Cartridge also requires an MD9 license.

Conclusion

Navigating the process of obtaining a manufacturing license can be a complex procedure, fraught with intricacies. Seeking expert consultancy can not only ease the process but ensure compliance with all regulations and norms. At Pharmadocx Consultants, we offer comprehensive services to assist you through every step of acquiring your manufacturing license.

You can reach out to us for more details and support via our website "https://www.pharmadocx.com", call us on "+91-7404557227", or drop us an email at "[email protected]".

To read more about the MD9 license, please visit "https://pharmadocx.com/cdsco-md9-manufacturing-license-consultant-for-medical-devices-in-india/".

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