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CDSCO Manufacturing License for Warming high-flow infusion pump

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the premier regulatory body in India responsible for the safety, quality, and efficacy of medical devices and pharmaceuticals. It operates under the directives of the Ministry of Health & Family Welfare. Its focus lies in the standardization and regulation of medical devices and drugs, ensuring they follow the highest standards before entering the market.

Manufacturing licenses play a critical role in the medical device industry, serving as a regulatory measure to protect consumers and maintain quality assurance. One such regulated device is the Warming high-flow infusion pump, which plays a vital role in providing medical treatment for patients. This pump is often used during surgical procedures involving major bleeding, burns, or injuries. You can find more detailed information about obtaining a manufacturing license for medical devices on CDSCO's portal here.

What is Warming high-flow infusion pump?

A Warming high-flow infusion pump is a device designed for the rapid heating and infusion of blood or other fluids during surgical procedures. The purpose of this essential piece of medical equipment is to mitigate the risks associated with hypothermia that can occur during major surgical procedures. They are used to infuse warm fluids and maintain the body’s temperature, hence preventing complications like hypothermia.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a rich history and a vital mission in ensuring the safety and quality of medical devices like the Warming high-flow infusion pump. They aim to create a robust regulatory framework for medical devices that protects patients while facilitating the growth of India's medical device industry.

How to manufacture Warming high-flow infusion pump

Depending upon the risk class, different licenses are required for manufacturing medical devices. For instance, with a risk class of C, a Warming high-flow infusion pump requires an MD9 license.

Fees for manufacturing license for Warming high-flow infusion pump

For obtaining an MD9 license, an initial fee of Rs. 50,000 is required, followed by Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Warming high-flow infusion pump?

A manufacturing license is mandatory for producing any medical device. It plays a crucial role in ensuring quality and safety in the production of medical devices. Furthermore, it reaffirms the significance of regulatory compliance in the healthcare sector, assuring consumers and patients against substandard products.

Steps to Obtain a CDSCO Manufacturing License for Warming high-flow infusion pump

Acquiring a license includes, but is not limited to, providing a Device Master File, Quality Management Certificate, Device Details, Site details, and other relevant documentation. During the application process, be prepared to submit documents, handle inspections, address queries and await the approval. Understanding these steps and how to navigate these challenges is where professional assistance can prove invaluable.

Frequently Asked Questions (FAQs)

  • Q: What is the risk class of the Warming high-flow infusion pump as per Medical Device Rules, 2017?

A: The Warming high-flow infusion pump falls under the risk class 'C'.

  • Q: What license is needed to manufacture the Warming high-flow infusion pump?

A: An MD9 license is required to manufacture the Warming high-flow infusion pump.

  • Q: What is the fee for the MD9 license for the Warming high-flow infusion pump?

A: The fee for the MD9 license is Rs. 50,000 and an additional Rs. 1000 per product.

  • Q: Who will issue the manufacturing license for the Warming high-flow infusion pump?

A: The manufacturing license for class C devices like the Warming high-flow infusion pump is issued by the CDSCO headquarters in New Delhi.

  • Q: Is repackaging of the Warming high-flow infusion pump considered manufacturing?

A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices like the Warming high-flow infusion pump fall under this definition. Repackaging of this device would also necessitate obtaining an MD9 license.

Conclusion

Obtaining a CDSCO Manufacturing License for medical devices can appear to be a daunting task due to its complex process and intricate regulatory compliance. However, with guided professional assistance and insights, the process can become less challenging. Our team of experts at Pharmadocx Consultants provide dedicated support to help you navigate through the licensing process. Reach out for consultation or assistance on our website Pharmadocx, by calling us at +91-7404557227, or emailing us at [email protected].

For more information regarding the licensing process for the MD9 license, you can refer to the detailed article here.

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