CDSCO Manufacturing License for Oxygen/air breathing gas mixer

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the Indian healthcare sector. Tasked with ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices, this regulatory body is indispensable to India's health and economy.¹

One area that CDSCO heavily impacts is the manufacturing of medical devices. Given the crucial role that these devices play in healthcare delivery and patient well-being, the importance of manufacturing licenses cannot be overstated. These licenses guarantee compliance with stringent quality and safety standards, protecting patients and healthcare providers alike.

In this post, we are going to focus on a specific medical device — the Oxygen/air breathing gas mixer. This Anesthesia device is an essential medical tool, and manufacturing it in compliance with CDSCO regulations is integral to its effectiveness and safety.

More details about CDSCO and its various activities can be found on their official portal here.

• What is Oxygen/air breathing gas mixer?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Oxygen/air breathing gas mixer
• Fees for manufacturing license for Oxygen/air breathing gas mixer
• Why is a Manufacturing License Necessary for Oxygen/air breathing gas mixer?
• Steps to Obtain a CDSCO Manufacturing License for Oxygen/air breathing gas mixer
• Frequently Asked Questions (FAQs)
• Conclusion

What is Oxygen/air breathing gas mixer?

An Oxygen/air breathing gas mixer is a portable mechanical device designed to mix air and oxygen during first aid or emergency situations. This device is a crucial part of the medical landscape, particularly in Anesthesia procedures, due to its contribution to maintaining a patient's vital functions during operations.

The Role of CDSCO in Medical Device Regulation

CDSCO has a rich legacy of safeguarding public health in India through strict regulation and monitoring of pharmaceutical products and medical devices. One of its main duties is the administration of the Medical Device Rules, which govern the manufacture, sale, and distribution of medical devices.

The regulatory framework emphasizes not only the physical safety of these devices but also their efficacy and performance. CDSCO continually adapts its regulations to keep pace with technological advancements in the medical field, thus ensuring the highest possible standards of patient safety and care.

How to manufacture Oxygen/air breathing gas mixer

The manufacturing of an Oxygen/air breathing gas mixer must comply with the guidelines outlined in the Medical Device Rules administered by the CDSCO. The manufacturing process should be holistic, beginning from the sourcing of materials to the rigorous testing for quality and efficacy.

Fees for manufacturing license for Oxygen/air breathing gas mixer

As a class B medical device as per Medical Device Rules, 2017, manufacturing an Oxygen/air breathing gas mixer requires an MD5 license. The cost of this license is Rs. 5,000, with an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Oxygen/air breathing gas mixer?

Manufacturing licenses are mandatory for several reasons:

1. They ensure quality and safety in medical device production.
2. They support regulatory compliance in the healthcare sector.
3. They protect consumers from substandard products.

Careful adherence to these regulations helps maintain trust in the healthcare sector and fosters a safe environment for patients and medical professionals.

Steps to Obtain a CDSCO Manufacturing License for Oxygen/air breathing gas mixer

Obtaining a manufacturing license requires careful preparation and strict adherence to protocol. Here are the basic steps involved:

1. Gather the required documentation, such as Device Master File, Quality Management Certificate, Device Details, Site details, and more.
2. Submit your completed application to the designated authority.
3. Wait for your application to be reviewed and approved.
4. Resolve any issues that might arise during the application process promptly.

For more information about the MD5 license needed for manufacturing a class B medical device like the Oxygen/air breathing gas mixer, click here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Oxygen/air breathing gas mixer as per Medical Device Rules, 2017?

The Oxygen/air breathing gas mixer is a class B device as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Oxygen/air breathing gas mixer?

An MD5 license is required to manufacture an Oxygen/air breathing gas mixer.

Q3. What is the fee for an MD5 license for Oxygen/air breathing gas mixer?

The fee for an MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Oxygen/air breathing gas mixer?

As a class B device, the state FDA will issue the license for manufacturing the Oxygen/air breathing gas mixer.

Q5. Is repackaging of Oxygen/air breathing gas mixer considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Therefore, repackaging of an Oxygen/air breathing gas mixer will also require an MD5 license.

Conclusion

We hope this guide was informative and helpful. If you need consultation on CDSCO medical device licenses, or assistance regarding the licensing process, please feel free to reach out to the knowledgeable team at Pharmadocx Consultants. You can contact them through the website, call them on +91-7404557227, or email your queries to [email protected].