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CDSCO Manufacturing License for Powered rectal/colostomy irrigation system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. When it comes to the manufacture of medical devices, obtaining the necessary licenses is crucial. This license ensures that the product adheres to precise standards, guaranteeing its efficacy and safety.

The medical device in focus for this blog post is the Powered rectal/colostomy irrigation system. This device plays a significant role in the field of Gastroenterology, used primarily to treat patients suffering from faecal incontinence or constipation.

For more information, please visit CDSCO's portal here.

What is a Powered rectal/colostomy irrigation system?

A Powered rectal/colostomy irrigation system is a battery-powered ensemble used for controlled introduction of a non-medicated solution, typically water, into patients' rectum. This device is most commonly used to treat conditions such as faecal incontinence and constipation. Besides, it aids in irrigation of colostomy sites for patients who have undergone colostomy.

The Role of CDSCO in Medical Device Regulation

The CDSCO operates under the Drugs and Cosmetics Act. Its mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. CDSCO regulates the manufacturing of medical devices in India through a comprehensive process involving licensing, inspections, and monitoring.

How to manufacture a Powered rectal/colostomy irrigation system

The manufacturing of a Powered rectal/colostomy irrigation system, a Class B medical device, necessitates adherence to CDSCO’s guidelines. Manufacturers must obtain the appropriate manufacturing license, which in this case is an MD5 license.

Fees for a manufacturing license for a Powered rectal/colostomy irrigation system

The fees for obtaining an MD5 license to manufacture a Class B medical device like a Powered rectal/colostomy irrigation system is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for a Powered rectal/colostomy irrigation system?

Ensuring quality, safety, and efficacy are integral components of the medical device production process. A manufacturing license is mandatory for a Powered rectal/colostomy irrigation system, like all medical devices. This requirement is established to protect patients from substandard products and to ensure that the healthcare sector maintains adherence to regulatory compliance.

Steps to Obtain a CDSCO Manufacturing License for a Powered rectal/colostomy irrigation system

  1. Ensure all pre-requisites are satisfied and necessary documentation, such as Device Master File, Quality Management Certificate, Device Details, Site details, is ready.
  2. Submit the application for a manufacturing license through the appropriate channels.
  3. Follow through the process, ensuring all requirements are met throughout the period up until approval of the license.
  4. Be aware of potential challenges in the application process and be prepared to address them.

For more detailed information about obtaining an MD5 license, you can refer to this link.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Powered rectal/colostomy irrigation system as per Medical Device Rules, 2017?

The risk class of a Powered rectal/colostomy irrigation system as per Medical Device Rules, 2017, is Class B.

Q2. What license is needed to manufacture a Powered rectal/colostomy irrigation system?

An MD5 license is required to manufacture a Powered rectal/colostomy irrigation system.

Q3. What is the fee for an MD5 license for a Powered rectal/colostomy irrigation system?

The fee for an MD5 license for a powered rectal/colostomy irrigation system is Rs. 5,000 for the license, and Rs. 500 per product.

Q4. Who will issue a manufacturing license for a Powered rectal/colostomy irrigation system?

The state FDA will issue the manufacturing license for a Powered rectal/colostomy irrigation system which is a class B device.

Q5. Is repackaging of a Powered rectal/colostomy irrigation system considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices are also classified as drugs and the same rules apply. Hence repackaging of a Powered rectal/colostomy irrigation system is also considered manufacturing, requiring an MD5 license.

Conclusion

Navigating the licensing process can be complex and time-consuming. As leaders in medical and pharmaceutical consulting, Pharmadocx Consultants can provide expert guidance to streamline the process and ensure compliance. We encourage anyone interested in manufacturing medical devices to reach out via link, phone at +91-7404557227 or email us at [email protected]. We are here to assist and guide you every step of the way.

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