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CDSCO Manufacturing License for Shunt thrombus suction set

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in the Indian medical devices sector, ensuring the safety and efficacy of products that directly impact patient health. The regulatory body tasks itself with strengthening the national healthcare sector and bolstering India's status as a global healthcare pioneer. This requires ensuring the standardization and control of drugs and medical devices – a responsibility carried out through rigorously applying manufacturing licenses. One such device of medical significance is the Shunt Thrombus Suction Set used extensively in nephrology and renal care. Eager manufacturers can learn more about CDSCO and its licensing process at CDSCO's portal.

What is a Shunt Thrombus Suction Set?

The Shunt Thrombus Suction Set is a unique medical device specifically designed to suction a thrombus (blood clot) in an arteriovenous shunt during procedures like hemodialysis. Hemodialysis, an integral facet of nephrology, and renal care, relies heavily on this device for maintaining the patency of the shunt.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been serving as the cornerstone of medical device regulation in India since its inception. Its mission – to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. For the Shunt Thrombus Suction Set and similar medical devices, CDSCO provides a comprehensive regulatory framework to control their performance and safety standards.

How to Manufacture a Shunt Thrombus Suction Set

The production process of a Shunt Thrombus Suction Set involves strict compliance with CDSCO regulations. Given its classification as a Class B device, specific controls and standard operative procedures should be followed meticulously to ensure the device's quality and safety.

Fees for Manufacturing License for a Shunt Thrombus Suction Set

Manufacturing a Class B device such as the Shunt Thrombus Suction Set requires an MD5 license. The MD5 license incurs a cost of Rs. 5,000, and an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for a Shunt Thrombus Suction Set?

Obtaining a manufacturing license is vital to ensure the quality, safety, and compliance with regulatory standards of medical devices. Besides, regulatory compliance protects consumers and patients from subpar products, ultimately uplifting the reputation of the healthcare service providers.

Steps to Obtain a CDSCO Manufacturing License for a Shunt Thrombus Suction Set

To secure a manufacturing license for your Shunt Thrombus Suction Set, prepare a Device Master File, Quality Management Certificate, and other details about the device and its manufacturing site. Following this, submit your application, making sure to comply promptly with additional requests during the approval process. Further details on navigating the license acquisition process — including potential challenges — are available here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Shunt Thrombus Suction Set as per Medical Device Rules, 2017?

  • A: Shunt Thrombus Suction Set is classified as a Class B medical device.

Q2. What license is needed to manufacture Shunt Thrombus Suction Set?

  • A: Manufacturing a Shunt Thrombus Suction Set requires an MD5 license.

Q3. What is the fee for an MD5 license for a Shunt Thrombus Suction Set?

  • A: The license 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 a Shunt Thrombus Suction Set?

  • A: The state FDA issues the license for manufacturing Class B devices like the Shunt Thrombus Suction Set.

Q5. Is repackaging of a Shunt Thrombus Suction Set considered manufacturing?

  • A: Yes. Repackaging of drugs, as per the Drugs and Cosmetics Act's definition of manufacturing, also applies to medical devices. The repackaging of a Shunt Thrombus Suction Set, therefore, is considered manufacturing requiring an MD5 license.

Conclusion

The process to produce Shunt Thrombus Suction Set—and other such medical devices—doesn't have to be haphazard. Assured regulatory compliance significantly eases the way to success in the healthcare sector. To learn more or to seek assistance regarding the licensing process, reach out to Pharmadocx Consultants, call "+91-7404557227" or email at "[email protected]". The journey to medical device manufacturing can be hassle-free with Pharmadocx Consultants by your side.

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