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CDSCO Manufacturing License for High-flow blood transfusion pump

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Introduction

Manufacturing of medical devices is regulated worldwide to ensure safety, quality, and efficacy. In India, the Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority responsible for overseeing the safety, efficacy, and quality of medical devices. It plays a vital role in guaranteeing the quality of the products made available in the Indian market and affiliation to international standards.

Manufacturing licenses are critical in the medical device industry. They help with maintaining quality in manufacturing, ensuring that good manufacturing practices are followed, and giving confidence to customers about the product's integrity. In this blog, we delve into the specificities of obtaining a CDSCO manufacturing license for High-flow blood transfusion pumps.

High-flow blood transfusion pumps are specific medical equipment used in conditions necessitating rapid infusion of blood or other fluids, such as surgical operations involving major bleeding or extensive burns and injuries. To learn more about CDSCO and its processes, you can visit the CDSCO portal here.

What is a High-flow Blood Transfusion Pump?

A high-flow blood transfusion pump is a medical device designed for rapidly infusing blood or other body fluids during surgical procedures involving major blood loss, burns or injuries. Its purpose is to speed up the process of blood transfusion, enhancing the management of high-risk medical procedures. These devices are commonly used in operating theatres, intensive care units (ICUs), and emergency departments.

The Role of CDSCO in Medical Device Regulation

CDSCO is the national regulatory agency for Indian pharmaceuticals and medical devices, akin to the US FDA. Its mission is to safeguard and improve public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. They have established a robust regulatory framework for medical devices, ensuring the highest quality levels are met during manufacturing.

How to manufacture a High-flow blood transfusion pump

Manufacturing of medical devices, including a High-flow blood transfusion pump, requires adherence to guidelines stipulated by the CDSCO, encompassing sustainable procurement of raw materials, quality control measures, routine testing, and adherence to Good Manufacturing Practices (GMP).

Fees for the manufacturing license of a High-flow blood transfusion pump

The license needed to manufacture a High-flow blood transfusion pump is MD9. The fee for the MD9 license is Rs. 50,000, and an additional Rs. 1,000 per product is required. You can know more about MD9 license from this informative article here.

Why is a Manufacturing License Necessary for a High-flow blood transfusion pump?

It is mandatory to take a manufacturing license to ensure quality and safety in medical device production. Regulatory compliance in the healthcare sector is crucial to guard against potential harm from substandard products. Moreover, manufacturing licenses protect consumers and patients.

Steps to Obtain a CDSCO Manufacturing License for a High-flow blood transfusion pump

  1. Prepare necessary pre-requisites and documentation: This includes a Device Master File, Quality Management Certificate, Device Details, Site details, and other relevant documents.
  2. Submit the application form: The application should be submitted to CDSCO through the Sugam portal.
  3. Periodic follow up: Regular tracking of the application help quicken the process.
  4. Approval: The approval of the license normally takes a few weeks and is subject to the review process by the CDSCO.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of a High-flow blood transfusion pump as per Medical Device Rules, 2017? A: It falls under Risk Class C.
  2. Q: What license is needed to manufacture a High-flow blood transfusion pump? A: You need an MD9 license to manufacture a High-flow blood transfusion pump.
  3. Q: What is the fee for an MD9 license for a High-flow blood transfusion pump? A: The fee for an MD9 license is Rs. 50,000, and an additional Rs. 1,000 per product is needed.
  4. Q: Who will issue the manufacturing license for a High-flow blood transfusion pump? A: For Class C devices, the CDSCO HQ in New Delhi will issue the manufacturing license.
  5. Q: Is repackaging of a High-flow blood transfusion pump considered manufacturing? A: Yes, repackaging of medical devices is considered manufacturing and requires a license.

Conclusion

Obtaining a manufacturing license for medical devices like a High-flow blood transfusion pump is a comprehensive process involving numerous dedicated steps. For assistance with the licensing process, reach out to Pharmadocx Consultants for expert consultation. Visit the website by clicking here, call on "+91-7404557227", or email at "[email protected]".

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