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CDSCO Manufacturing License for Extracorporeal circuit waste bag

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary body for the regulation of pharmaceuticals and medical devices. Manufacturing licenses are crucial in the healthcare industry as they help safeguard public health by ensuring that only superior quality medical devices are manufactured and supplied. Today, in the spotlight, we have the Extracorporeal Circuit Waste Bag, a distinct medical device that significantly contributes to the field of Nephrology and Renal Care. To learn more about medical devices and their related licenses, I recommend CDSCO's portal, here.

What is an Extracorporeal Circuit Waste Bag?

An Extracorporeal Circuit Waste Bag is a medical device designed to collect waste fluids during the preparation and processing of an extracorporeal circuit. This includes procedures such as haemodialysis, haemofiltration, apheresis, and adsorption treatments. The bag also serves the purpose of collecting and rinsing ultrafiltrate fluid, which may contain blood components.

The Role of CDSCO in Medical Device Regulation

Originally established as the Central Drugs Laboratory in Kolkata in 1931 under the Drugs and Cosmetics Act, CDSCO has evolved into a pivotal entity of the Ministry of Health and Family Welfare, Government of India. It ensures the safety, quality, and efficacy of medical devices and pharmaceutical products throughout the country.

How to Manufacture Extracorporeal Circuit Waste Bag

Complying with strict quality assurance protocols is crucial during the manufacturing of Extracorporeal Circuit Waste Bags. Manufacturers must obtain an MD5 license as per the guidelines of CDSCO to ensure safety and hygiene standards are maintained given its class B risk category.

Fees for Manufacturing License for Extracorporeal Circuit Waste Bag

For a Class B device like the Extracorporeal Circuit Waste Bag, an MD5 license is needed. The fees for obtaining this license are Rs. 5,000 with an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for Extracorporeal Circuit Waste Bag?

Applications for a manufacturing license are mandatory and ensure the product adheres to the highest standards of quality and safety required in medical device production. Regulatory compliance in the healthcare sector is significant, ensuring protection against substandard products for consumers and patients.

Steps to Obtain a CDSCO Manufacturing License for Extracorporeal Circuit Waste Bag

  1. Prepare necessary documentation such as the Device Master File, Quality Management Certificate, Device Details and Site details.
  2. Submit application for review.
  3. Await the licensing authority's approval.
  4. Address any challenges during the review process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Extracorporeal Circuit Waste Bag as per Medical Device Rules, 2017?

Class B is the risk class of an Extracorporeal Circuit Waste Bag.

Q2. What license is needed to manufacture an Extracorporeal Circuit Waste Bag?

An MD5 license is required.

Q3. What is the fee for an MD5 license for an Extracorporeal Circuit Waste Bag?

The license costs Rs. 5,000, plus Rs. 500 per product.

Q4. Who will issue manufacturing license for Extracorporeal Circuit Waste Bag?

The State FDA will issue the license for the Extracorporeal Circuit Waste Bag.

Q5. Is the repackaging of an Extracorporeal Circuit Waste Bag considered manufacturing?

Yes, repackaging of medical devices, including the Extracorporeal Circuit Waste Bag, is considered manufacturing and requires an MD5 license.

Conclusion

Securing a manufacturing license may seem daunting, but with the right guidance, the process becomes a lot easier. For professional assistance with CDSCO licenses, consider reaching out to Pharmadocx Consultants. You can also contact them by phone on +91-7404557227 or email at [email protected]. For further support and detailed information, you can read more about MD5 licenses here.

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