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CDSCO Manufacturing License for Anaesthesia workstation gas scavenger

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Introduction

Central Drugs Standard Control Organization (CDSCO) in India is the central regulatory authority for the quality control, licensing, formulation of standards, and regulation of import/export of medical devices. Ensuring the safety and quality of drugs, cosmetics, diagnostics, and devices in the country, it plays a vital role in fostering public health.

In the medical device industry, owning a manufacturing license is of paramount importance. It marks the entry into a regulated market, ensuring the reliability and safety of the medical devices produced. It reflects the manufacturer's adherence to the rules and regulations that govern the medical device industry.

Today, we delve into the world of Anaesthesia workstation gas scavengers, a Class B medical device. This device plays a critical role in the operating room, ensuring the safe disposal of waste anaesthetic gases. For more information, visit CDSCO's portal.

What is an Anaesthesia workstation gas scavenger?

Anaesthesia workstation gas scavenger is a device that connects the expiratory valve/port of a breathing circuit to the extraction system. Its main function is to remove waste anaesthetic, exhaled, or other trace gases from the work environment and channel them outside the building. It ensures a safer and cleaner workspace for healthcare professionals.

This device is used widely in various medical procedures, especially in those involving the use of anesthesia. It plays an important role in maintaining air quality in the operation theatre and protecting medical staff from prolonged exposure to waste anesthetic gases.

The Role of CDSCO in Medical Device Regulation

Over the span of its existence, CDSCO has been dedicated to protecting and promoting public health, by ensuring the safety, efficacy, and quality of drugs and medical devices. Its regulatory framework for medical devices is comprehensive and structured, designed to facilitate the production of high-quality, safe, and effective medical devices.

How to manufacture an Anaesthesia workstation gas scavenger?

Given that an Anaesthesia workstation gas scavenger is a Class B medical device, the manufacturing process requires adherence to certain standards and regulations set by CDSCO. This is to ensure the utmost quality and safety of the device.

Fees for manufacturing license for Anaesthesia workstation gas scavenger

The manufacturing license for a Class B medical device such as the Anaesthesia workstation gas scavenger requires an MD5 license. The fee for obtaining an MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for an Anaesthesia workstation gas scavenger?

Manufacturing licenses are obligatory for the production of medical devices, not only to maintain a certain level of quality and safety but also to conform to the rules and regulations set by the regulatory authorities.

They play a significant role in assuring regulatory compliance in the healthcare sector. Hence, a license is necessary for the manufacturing of an Anaesthesia workstation gas scavenger.

Steps to Obtain a CDSCO Manufacturing License for an Anaesthesia workstation gas scavenger

Obtaining a manufacturing license involves presenting the Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application process includes submission of all required documents to obtaining approval. Clear details on how to apply for the license can be found in these articles MD-5

Frequently Asked Questions (FAQs)

1. What is the risk class of Anaesthesia workstation gas scavenger as per Medical Device Rules, 2017?

  • The risk class for Anaesthesia workstation gas scavenger is Class B.

2. What license is needed to manufacture Anaesthesia workstation gas scavenger?

  • MD5 license is required to manufacture Anesthesia workstation gas scavenger.

3. What is the fee for the MD5 license for Anaesthesia workstation gas scavenger?

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

4. Who will issue the manufacturing license for Anaesthesia workstation gas scavenger?

  • For Class B devices like the Anaesthesia workstation gas scavenger, the state FDA will issue the license.

5. Is repackaging of Anaesthesia workstation gas scavenger considered manufacturing?

  • Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and by definition, medical devices are considered manufacturing. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Anaesthesia workstation gas scavenger is also considered manufacturing requiring an MD5 license.

Conclusion

Navigating through the regulatory processes might seem overwhelming, but it doesn't have to be. Expert consultancy services like Pharmadocx Consultants can assist you in understanding and simplifying the process of obtaining a manufacturing license. Reach out to us at +91-7404557227 or email us at [email protected] for consultations or any other information you may need.

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